[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteoporosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteoporosis":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,113,0,25,[9,41,71,98,125,157,181,210,240,265,287,314,339,372,401,423,447,473,494,522,546,571,597,623,650],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100652795","the-relationship-between-lipedema-and-osteoporosis-100652795",false,"NCT07779603","The Relationship Between Lipedema and Osteoporosis","The Relationship Between Lipedema and Osteoporosis: A Cross-Sectional Observational Study","Inclusion Criteria:\n\n* being literate\n* voluntarily agreeing to participate in the study\n* being a postmenopausal woman\n* having a diagnosis of lipedema\n\nExclusion Criteria:\n\n* the presence of other types of edema in which a component other than lipedema predominates (e.g., lymphedema, venous edema, edema associated with heart or kidney failure, etc.)\n* chronic liver disease,\n* body mass index (BMI) of over 50.0 (this condition reflects severe obesity, which has a significant impact on health beyond lipedema alone)\n* the presence of rheumatological diseases that may lead to secondary osteoporosis\n* a history of cancer, endocrine disorders, neurological disorders, certain gastrointestinal disorders\n* use of medications related to osteoporosis\n* being under 18 years of age",true,"ALL","18 Years",{"count":21,"type":22},120,"ESTIMATED","1 Day","OBSERVATIONAL","The purpose of this study is to evaluate the relationship between lipedema and osteoporosis and to examine factors that may be associated with osteoporosis in individuals with lipedema.",[27,28],"Lipedema","Osteoporosis","NOT_YET_RECRUITING","2026-08-18",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":22},"2026-08-20",{"date":37,"type":22},"2026-09-16",{"name":39,"class":40},"Fatih Sultan Mehmet Training and Research Hospital","OTHER",{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100546511","dynamics-in-bone-turnover-markers-during-and-after-short-term-glucocorticoid-treatment-in-patients-with-an-inflammatory-joint-disease-100546511","NCT06395883","Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease","Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease - the BOOGIE Study","BOOGIE","Inclusion Criteria:\n\n* diagnosis of inflammatory rheumatic joint disease\n* indication of disease modifying treatment initiation with or without glucocorticoids OR\n* stable DMARD treatment with parenteral glucocorticoid injection\n\nExclusion Criteria:\n\n* known osteoporosis or osteoporosis treatment\n* women during the transitory phase\n* oestrogen treatment\n* any fracture within the last year\n* chronic glucocorticoid treatment\n* glucocorticoid treatment within the last year prior to inclusion\n* active cancer\n* kidney failure","25 Years","90 Years",{"count":52,"type":22},160,"Bone turnover markers (BTMs) are recommended as an important tool in follow-up of osteoporosis treatment. However, there is a lack of knowledge in the reliability of BTMs during and after glucocorticoid treatment. Glucocorticoids suppresses BTMs during treatment with at least 30% and, moreover, glucocorticoids increase the risk of fractures. Patients with an inflammatory joint disease are at increased risk of osteoporosis, and disease flares are often treated with glucocorticoids, which in turn can lead to loss in reliability of the BTMs in patients who also are on osteoporosis treatment.\n\nThere is a need of more knowledge on BTM changes during and after glucocorticoid treatment for optimized patientcare, reduced risk of side effects and reduced health economic costs.",[28,55,56],"Osteoporosis, Steroid Induced","Inflammatory Rheumatism",[58,59,60],"Bone turnover","Bone turnover markers","Glucocorticoids","RECRUITING",{"date":63,"type":33},"2026-08-19",{"date":65,"type":33},"2025-01-01",{"date":67,"type":22},"2028-12",{"name":69,"class":40},"Diakonhjemmet Hospital",2,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100640591","post-osteoporotic-fracture-exercise-program-100640591","NCT07595991","Post-osteoporotic Fracture Exercise Program","Community Osteoporosis Exercise Class for People Post Fracture","Inclusion Criteria:\n\n* Diagnosed with osteoporosis.\n* History of low trauma fracture within the past year\n* Cleared for physical activity using the get active questionnaire, 100 bpm resting heart rate or less, 160 mm Hg diastolic blood pressure or less\n* Able to understand and provide informed consent.\n* Residing within the study's geographic area (e.g., London, Ontario).\n\nExclusion Criteria:\n\n* Individuals who do not understand the English language\n* Medical conditions contraindicating participation in exercise (e.g., uncontrolled cardiovascular disease, severe respiratory illness).\n* Cognitive impairments that prevent informed consent or participation.\n* Recent major surgeries or medical events limiting physical activity.\n* Participation in conflicting clinical trials or rehabilitation programs.\n* Residents outside the designated study area.",{"count":79,"type":22},100,"INTERVENTIONAL",[82],"NA","Those with osteoporosis often have weaker bones and this leads to higher chances of fractures. Therefore, the investigators want to evaluate the feasibility and safety of group exercise classes specifically designed for individuals with osteoporosis who had an osteoporotic fracture. By focusing on this high-risk population, the investigators want to see whether such exercise interventions can be an option for improving bone health, reducing the risk of future fractures, and enhancing physical function without compromising safety.",[28,85],"Osteoporotic Fracture",[28,87,88],"Exercise Intervention","Osteoporotic fracture","2026-08-17",{"date":35,"type":33},{"date":92,"type":22},"2026-09",{"date":94,"type":22},"2028-02",{"name":96,"class":40},"Western University, Canada",1,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":124},"100495566","osteomics-identifying-regulators-of-bone-homeostasis-100495566","NCT05732870","OSTEOMICS: Identifying Regulators of Bone Homeostasis","OSTEOMICS","Inclusion Criteria:\n\n1. Patients with osteoarthritis undergoing total joint arthroplasty, osteotomy or arthrodesis of any joint (including hip, knee, shoulder, wrist, elbow, ankle).\n2. Patient with fractured neck of femurs undergoing hemiarthroplasty or total hip arthroplasty, or other internal fixation procedure.\n3. Patients undergoing acute low-velocity or fragility fracture fixation surgery.\n4. Patients aged between 18-110 years old with capacity to consent.\n\nSince deteriorating bone health including diseases like osteoporosis are primarily conditions of older age there is no practical upper age-limit. However, study involvement is limited by suitability for surgery which encompasses multiple factors considered on an individual case basis including age, frailty, comorbidities, baseline mobility, renal function and ability to consent (for instance due to dementia or delirium).\n\nWe note that our inclusion criteria is purposefully broad as we aim to deduce trends across a wide range of conditions and backgrounds.\n\nExclusion Criteria:\n\n1. Patients unable to provide informed consent.\n2. Patients with suspected\u002Festablished underlying malignancy.\n3. Patients with suspected\u002Festablished osteomyelitis.\n4. Patients with suspected\u002Festablished bloodborne disease\n5. Patients who are currently a subject of a clinical trial involving an investigational medicinal product.","110 Years",{"count":107,"type":22},2000,"Diseases of bone associated with ageing, including osteoporosis (OP) and osteoarthritis (OA), reduce bone mass, bone strength and joint integrity. Current non-surgical approaches are limited to pharmaceutical agents that are not disease modifying and have poor patient tolerability due to side effect profiles. Developing a fundamental understanding of cellular bone homeostasis, including how key cell types affect tissue health, and offering novel therapeutic targets for prevention of bone disease is therefore essential. This is the focus of OSTEOMICS.\n\nA number of factors have been linked to increased risk of bone disease, including genetic predisposition, diet, smoking, ageing, autoimmune disorders and endocrine disorders. In our study, we will recruit patients undergoing elective and non-elective orthopaedic surgery and obtain surgical bone waste for analysis. This will capture a cohort of patients with bone disorders like OP and OA, in addition to patients without overt clinical bone disease. We will study the relationship between the molecular biology of bone cells, bone structure, genetics (DNA) and environmental factors with the aim of identifying and validating novel therapeutic targets.\n\nWe will leverage modern single cell technologies to understand the diversity of cell types found in bone. These technologies have now led to the characterisation of virtually every tissue in the body, however bone and bone-adjacent tissues are massively underrepresented due to the anatomical location and underlying technical challenges. Early protocols to demineralise bone and perform single cell profiling have now been developed. We will systematically scale up these efforts to observe how genetic variation at the population level leads to alterations in bone structure and quality.\n\nOver the next 10 years, we will generate data to comprehensively characterise bone across health and disease, use machine learning to drive analysis, and experimentally validate hypotheses - which will ultimately contribute to developing the next generation of therapeutic agents.",[28,110,111,112,113],"Osteoarthritis","Bone Diseases","Bone Fracture","Bone Marrow Disease","2026-08-12",{"date":116,"type":33},"2026-08-14",{"date":118,"type":33},"2023-01-12",{"date":120,"type":22},"2032-12",{"name":122,"class":123},"Relation Therapeutics","INDUSTRY",8,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":17,"sex":132,"minAge":133,"maxAge":50,"enrollmentInfo":134,"targetDuration":4,"studyType":80,"phases":136,"briefSummary":137,"conditions":138,"keywords":143,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":97},"100651601","calcium-rich-food-versus-calcium-carbonate-for-bone-health-100651601","NCT07763509","Calcium-Rich Food Versus Calcium Carbonate for Bone Health","Evaluating Adherence, Tolerability, and Safety of a Novel Oral Dietary Calcium Chew vs. Calcium Carbonate in Women 40-90: A Real-Life, Prospective, Randomized Controlled Trial","Inclusion Criteria Female at birth, 40 to 90 years of age Family history of osteoporosis or history of fracture Willing and able to provide written informed consent Willing to comply with all study procedures Willing to refrain from making major dietary changes during the 4-week study No known allergy or intolerance to any study product ingredients Exclusion Criteria Medical condition that would interfere with study participation or adherence (including selected oncologic or psychiatric disorders) Known severe allergic reaction requiring an epinephrine auto-injector Pregnant, breastfeeding, or planning to become pregnant during the study Invasive medical procedure within the previous 3 months or planned during the study period Current participation in another research study or planning to participate during the study period Difficulty swallowing (dysphagia)\n\n\\-","FEMALE","40 Years",{"count":135,"type":22},217,[82],"This study will compare adherence, tolerability, safety, and treatment satisfaction between a calcium-rich food and a traditional calcium carbonate supplement in women ages 40 to 90 who are at increased risk for osteoporosis. Participants will be randomly assigned to receive either a calcium-rich food providing 500 mg of calcium from milk-derived minerals or a 500 mg calcium carbonate supplement once daily for four weeks. Participants will complete brief weekly questionnaires assessing supplement use, gastrointestinal symptoms, and treatment satisfaction. The goal of the study is to determine whether the form in which calcium is consumed influences adherence and participant experience. No blood draws, imaging studies, or other invasive procedures are involved",[139,28,140,141,142],"Osteopenia","Bone Health in Perimenopausal Women","Menopause Related Conditions","Fracture Healing",[28,144,145,146,147],"osteopenia","bone health","menopause","Fractures","2026-08-10",{"date":150,"type":33},"2026-08-13",{"date":152,"type":22},"2026-09-01",{"date":154,"type":22},"2027-10-01",{"name":156,"class":40},"Cornell University",{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":18,"minAge":165,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":80,"phases":168,"briefSummary":169,"conditions":170,"keywords":173,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":177,"leadSponsor":179,"locationsCount":97},"100651562","effectiveness-and-clinical-optimization-of-a-standardized-physiotherapy-exercise-program-targeting-balance-posture-interaction-and-fall-risk-in-osteoporosis-a-randomized-controlled-trial-100651562","NCT07763717","EFFECTIVENESS AND CLINICAL OPTIMIZATION OF A STANDARDIZED PHYSIOTHERAPY EXERCISE PROGRAM TARGETING BALANCE-POSTURE INTERACTION AND FALL RISK IN OSTEOPOROSIS: A RANDOMIZED CONTROLLED TRIAL","Effectiveness and Clinical Optimization of a Standardized Physiotherapy Exercise Program Targeting Balance-Posture Interaction and Fall Risk in Osteoporosis: A Randomized Controlled Trial","EFFECTIVENESS","Inclusion Criteria:o Confirmed clinical diagnosis of osteoporosis, established through standard diagnostic procedures such as bone mineral density (BMD) assessment (e.g., T-score ≤ -2.5 at the lumbar spine, femoral neck, or total hip) or a physician's diagnosis based on clinical history and fracture risk assessment.\n\n* Aged 50 years or older.\n* Ability to understand and follow verbal and written instructions in Albanian.\n* Ability to ambulate independently, with or without an assistive device, for at least 10 meters.\n* Willingness to provide informed consent and commit to the full 12-week intervention period and follow-up assessments.\n\nExclusion Criteria:\n\n* o Presence of any neurological disorder (e.g., Parkinson's disease, stroke) that significantly affects balance or mobility.\n\n  * Acute fractures or recent (within the last 6 months) osteoporotic fractures that would preclude participation in an exercise program.\n  * Severe cardiovascular or respiratory conditions that would contraindicate moderate-intensity exercise.\n  * Uncontrolled systemic diseases (diabetes, hypertension).\n  * Cognitive impairment that would interfere with understanding or adhering to the study protocol.\n  * Participation in another balance or strength training program within the last 3 months.\n  * Any other medical condition or medication use that, in the opinion of the primary investigator, would compromise participant safety or the integrity of the study results.","50 Years",{"count":167,"type":22},88,[82],"Osteoporosis is a systemic disorder of the skeletal system characterized by decreased Bone Mass and deterioration of the Microarchitecture, making it significantly easier to fracture the bones. In addition to the increased risk of fracture due to reduced Bone Strength, other common impairments in the balance, postural control and coordination of muscles may increase the risk of falling, as well. Recent research has increasingly begun to conceptually link fall risk to be a multi-factorial issue, due to the interaction of the biomechanical, neuromuscular and functional deficits that an older person most likely experiences in conjunction with the effects of ageing (Papalia et al., 2020). As such, physiotherapy techniques for treating persons at risk of falling have progressed away from providing isolated (and consequently limited) gains in strength or mobility, towards providing a more multi-faceted and thus comprehensive, integrated method of enhancing overall physical performance through exercise.\n\nPhysical activity interventions are being used to treat the condition of osteoporosis and have been identified as an essential component of preventing osteoporosis. Many recent statements have indicated that through the incorporation of organized physical activity into each individual's physical activity routine, as opposed to the previous recommendation for just resistance training and balance activities, the ability for individuals to experience a change in their physical abilities and thereby decrease their risk of falling is significantly improved (Brooke-Wavell et al., 2022; Bae et al., 2023). Among the many types of exercise-based interventions for treating osteoporosis, those that focus on improving balance have been shown to be effective in improving stability of the body postural position as well as decreasing the fear of falling (which can contribute to decreased mobility and increase the risk of falling) (Wei et al., 2023). A systematic review and analysis of the available literature indicates that targeted balance training is effective for improving both static and dynamic postural stability among older adults and persons with osteoporosis; moderate effects were found with regard to the risk of falling as a result of balance training (Zhou et al., 2018; Papalia et al., 2020).\n\nRandomized controlled trials provide additional evidence of the positive impact of physiotherapy programs on their clinical use. For Osteoporotic women, having balance training interventions leads to the to the outcome of significantly reducing falls and enhancing stability (Mikó et al., 2017). On the same note, Multicomponent programs that combine resistance and balance training have resulted in increased muscle strength, physical performance and health-related quality of life for patients with vertebral fractures, along with reduced fear of falling. (Stanghelle et al., 2020). Newer developments in this area such as virtual reality exercise programs have provided additional improvements in Balance performance and increased patient engagement in rehabilitation (Yilmaz \\& Kösehasanoğulları, 2024).",[28,171,172],"Risk of Falls","Rehabilitation",[174],"Physiotherapy, osteoporosis, balance, posture, risk of falls, exercise program, rehabilitation",{"date":150,"type":33},{"date":152,"type":22},{"date":178,"type":22},"2027-06-30",{"name":180,"class":40},"Alma Mater Europaea - Slovenia",{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":80,"phases":191,"briefSummary":193,"conditions":194,"keywords":197,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":97},"100650050","phase-1-pharmacokinetics-of-zoledronic-acid-in-patients-on-dialysis-100650050","NCT07741136","Pharmacokinetics of Zoledronic Acid in Patients on Dialysis","Pharmacokinetics of Zoledronic Acid in Patients With Chronic Kidney Disease on Dialysis","ZADIAL","Inclusion Criteria:\n\n* Individuals aged 18 years or older, with CKD-associated osteoporosis\n* eGFR ≥ 35 mL\u002Fmin\u002F1.73 m2 and advanced CKD on dialysis\n* Agree to participate in the research by signing the informed consent form\n\nExclusion Criteria:\n\n* Individuals under 18 years of age, pregnant or breastfeeding women\n* Patients with CKD with hypocalcemia\u002Fhypophsphatemia\n* Patients with CKD on dialysis with residual diuresis\\*\n* Patients with CKD on low-flux membrane dialysis\\*\n* Patients with neoplasia\n* Hypersensitivity to bisphosphonates, or previous use of the medication\n* Inadequate oral condition or anticipated invasive dental procedure within the next 12 months\n* Alkaline phosphatase \\\u003C 98 IU\u002FL or \\> 180 IU\u002FL\\*\n* PTH \\\u003C 130 pg\u002FmL and \\> 585 pg\u002FmL\\*\n* Severe liver disease\n* Severe heart disease\n* Clinical suspiction of osteomalacia\n* Cytopenias, defined as: platelets \\\u003C 120,000\u002Fmm³, neutrophils \\\u003C 3,000\u002Fmm³, lymphocytes \\\u003C 1,000\u002Fmm³ and hematocrit \\\u003C 26% \\* Applicable only to the group of patients undergoing dialysis.",{"count":190,"type":22},24,[192],"PHASE1","Osteoporosis is a frequent complication of chronic kidney disease (CKD) on dialysis, with an estimated prevalence of approximately 40%. It is associated with increased fracture risk, reduced quality of life, and higher mortality. Despite available therapies, management often remains suboptimal, partly due to limited evidence on the safety and pharmacokinetics of bisphosphonates in this population. Objectives: To understand the pharmacokinetics of zoledronic acid in CKD patients on dialysis, as well as to analyze its effects on biomarkers of bone metabolism, bone mineral density (BMD), and clinical outcomes. Materials and Methods: This prospective clinical study involves 24 adult individuals, 8 with CKD-associated osteoporosis (control group; estimated glomerular filtration rate (eGFR) ≥ 35 mL\u002Fmin\u002F1.73 m²) and 16 with CKD-associated osteoporosis anuric on dialysis patients. Individuals undergoing dialysis will be assigned to receive zoledronic acid at doses of 2.5 mg or 5 mg intravenously (single dose, at the beggining of dialysis session), while patients with CKD-associated osteoporosis (control group; estimated glomerular filtration rate (eGFR) ≥ 35 mL\u002Fmin\u002F1.73 m²) will receive 5 mg, also in a single dose. Serial blood samples will be collected after infusion, during dialysis session and again up to 96h after dialysis session initiation. The dialysate will be continuously sampled in a tank and aliquots collected for further analysis. The plasma levels of zoledronic acid will be calculated from blood and dialysate samples using liquid chromatography mass spectrometry. The primary outcome is the plasma concentration-time curve of zoledronic acid during a regular dialysis session. Secondary outcomes are: (i) plasma concentration of zoledronic acid up to 96h;(ii) the total mass of zoledronic acid extracted by the dialysate; (iii) the dialytic clearance of zoledronic acid. Evaluation of bone biomarkers (e.g., PTH, alkaline phosphatase, calcium, phosphorus, CTX, and P1NP) and BMD (assessed by bone densitometry) will be performed at baseline and at 12 months. The study will be conducted at the UNICAMP Clinical Hospital, with the participation of one participating center, subject to prior approval from the respective Research Ethics Committees. All participants will be included only after signing the Informed Consent Form. Data will be anonymized and processed in accordance with the General Data Protection Law (LGPD). Expected results: To characterize the pharmacokinetic profile and establish the best dosage regimen of zoledronic acid in patients with CKD on dialysis; to observe the impact of the drug on biomarkers of bone metabolism and BMD.",[195,28,196],"Chronic Kidney Disease","Dialysis",[198,199,196,200,28],"Zoledronic acid","bisphosphonate","Pharmacokinetics","2026-07-31",{"date":203,"type":33},"2026-08-03",{"date":205,"type":22},"2026-08-15",{"date":207,"type":22},"2028-08-15",{"name":209,"class":40},"University of Campinas, Brazil",{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":18,"minAge":218,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":80,"phases":221,"briefSummary":222,"conditions":223,"keywords":226,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":239},"100617973","us-prospective-evaluation-of-epione-device-for-percutaneous-msk-procedures-100617973","NCT07325578","U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures","Evaluation of the Epione Robotic System for Image-guided Percutaneous MSK Procedures of the Pelvis and Spine in USA. A Prospective Study on Feasibility, Safety and Accuracy","EPIOS","Inclusion Criteria:\n\n* Patients ≥22 years old,\n* Patients approved for CT- or CBCT-guided MSK procedure in the pelvis or spine (except the cervical area) under general anesthesia,\n* Patients who have signed an IRB-approved informed consent form\n* Patients approved for coverage by their insurance for routine costs involved in this standard of care procedure\n* Inclusion criteria linked to the freehand procedure have been discussed and validated\n\nExclusion Criteria:\n\n* Patients with contraindication to undergo general anesthesia,\n* Patients unable to maintain appropriate breathing control,\n* Patients requiring CT- or CBCT-guided percutaneous procedure on target areas other than those indicated\n* Patients unable to fully understand all relevant aspects of the clinical study necessary for their decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response,\n* Pregnant or breast-feeding women,\n* Patients subject to a legal protection measure,\n* Patients already participating in another conflicting interventional clinical study,\n* Patients for whom the scan field of view cannot contain the anatomy of interest, the overlaying skin surface, skin markers and the whole patient reference.\n* Patients having a coagulation abnormalities or bleeding disorder\n* Patients having an active infection on the day of intervention\n* Patients having a history of previous surgery resulting in an existing hardware precluding percutaneous approach\n* Exclusion criteria linked to the freehand procedure have been discussed and validated","22 Years",{"count":220,"type":22},60,[82],"The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults.\n\nThe main question is the determination of the rate of feasible procedures assisted by the Epione device\n\nParticipants will undergo their procedure(s) as planned by their physician. If they accept to participate to the study, the differences with standard of care will be:\n\n* The use of the Epione device to place the introducer(s), instead of freehand placement if they do not participate\n* Additional CT or CBCT scans during the procedure.",[224,28,225],"Bone Tumor","Traumatic Fracture",[227,228,229],"percutaneous procedure","robot assistance","bone procedure","2026-07-17",{"date":232,"type":33},"2026-07-20",{"date":234,"type":33},"2026-04-28",{"date":236,"type":22},"2027-03",{"name":238,"class":123},"Precision IO Group",3,{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":17,"sex":18,"minAge":247,"maxAge":248,"enrollmentInfo":249,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":4},"100647354","salivary-cytokines-mmp-8-and-dental-caries-in-osteoporosis-patients-100647354","NCT07709247","Salivary Cytokines, MMP-8 and Dental Caries in Osteoporosis Patients","Osteoporoz Hastalarında Tükürük Sitokin, Matrix Metalloproteinase 8 ve Diş Çürüğünün Değerlendirilmesi","Inclusion Criteria:\n\n* Willing to give voluntary consent For Group 1, having been diagnosed with osteoporosis For Group 2, being systemically healthy and not having a diagnosis of osteoporosis\u002Fosteopenia\n\nExclusion Criteria:\n\n* Having a chronic inflammatory or autoimmune disease Using glucocorticoids, anti-anxiety medications, antidepressants, or antiepileptic drugs Having been diagnosed with any malignancy Having any endocrine disease Having undergone periodontal treatment within the last 6 months","45 Years","75 Years",{"count":250,"type":22},50,"This study examines saliva samples from patients with osteoporosis. The levels of cytokines and Matrix Metalloproteinase-8 (MMP-8) enzyme in saliva will be measured. Additionally, the dental caries status of participants will be evaluated. The aim of this study is to understand the relationship between osteoporosis and oral health. Only saliva samples will be collected from participants; no treatment or medication will be administered.",[28,253,254,255],"Dental Caries","Biomarkers","Matrix Metalloproteinase 8","2026-07-12",{"date":258,"type":33},"2026-07-16",{"date":260,"type":22},"2026-07-10",{"date":262,"type":22},"2027-07-10",{"name":264,"class":40},"Afyonkarahisar Health Sciences University",{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":132,"minAge":165,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":80,"phases":274,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":97},"100520642","phase-4-the-optimised-use-of-romozosumab-study-100520642","NCT06059222","The Optimised Use of Romozosumab Study","OPTIMIST","Inclusion Criteria:\n\n* Postmenopausal women (postmenopausal for at least two years)\n* BMD T-score \\\u003C -2.5 at lumbar spine, total hip, or femoral neck\n* Osteoporotic fracture within the last 3 years at the spine, hip, pelvis, humerus or forearm after the age of 50 years.\n\nExclusion Criteria:\n\n* Osteoporosis treatment including hormone replacement therapy within the last 5 years\n* Metabolic bone disease\n* Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, liver dysfunction (baseline phosphatase higher than twice upper limit), rheumatism, severe COPD (chronic obstructive pulmonary disease), hypopituitarism, Cushing's disease\n* Ongoing treatment with glucocorticoids (systemic)\n* Estimated glomerular filtration rate (eGFR) \\\u003C 35 mL\u002Fmin\n* Contraindications for zoledronate according to the Supplementary protection certificates (SPC)\n* Contraindications for romosozumab according to the SPC\n* For the subgroup with Jamshidi biopsies contraindications for local anaesthetics according to the SPC\n* For the subgroup with Jamshidi biopsies contraindications for tetracycline or doxycykline according to the SPC",{"count":273,"type":22},270,[275],"PHASE4","OPTIMIST is a two-year, randomised, active controlled, open-label, multicentre intervention trial. OPTIMIST includes 3 treatment groups each comprising combinations of romosozumab (ROMO) and zoledronate (ZOL) treatment used in standard doses (210 mg monthly (sc) and 5 mg yearly (iv), respectively).\n\nThe study will investigate if it is possible to maximize the effect of romosozumab by giving it in 2 periods of 6 months interrupted by zoledronate for 12 months compared to romosozumab for 12 months uninterrupted followed by zoledronate for 12 months. The investigators will also evaluate if 6 months of romosozumab followed by 18 months of zoledronate is non-inferior to the standard regimen of romosozumab for 12 months followed by zoledronate for 12 months.",[28],"2026-07-01",{"date":280,"type":33},"2026-07-02",{"date":282,"type":33},"2023-10-02",{"date":284,"type":22},"2032-08-31",{"name":286,"class":40},"University of Aarhus",{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":132,"minAge":247,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":296,"conditions":297,"keywords":301,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":97},"100645032","can-serum-lumican-level-identify-a-hidden-fragility-phenotype-beyond-bone-mineral-density-in-postmenopausal-women-100645032","NCT07677072","Can Serum Lumican Level Identify a Hidden Fragility Phenotype Beyond Bone Mineral Density in Postmenopausal Women?","LUMINOS","Inclusion Criteria:\n\nInclusion Criteria:\n\n* Female sex\n* Age 45 years or older\n* Postmenopausal status\n* Attendance at the Physical Medicine and Rehabilitation outpatient clinic\n* Undergoing routine bone mineral density (DEXA) assessment and osteoporosis laboratory evaluation\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\nExclusion Criteria:\n\n* Premenopausal women\n* Secondary causes of osteoporosis (e.g., malignancy, advanced renal failure, severe liver disease, significant endocrine disorders)\n* Active infection or acute inflammatory disease\n* Major surgery within the previous 6 months\n* Neurological or muscular disorders that may significantly affect muscle function\n* Inability to comply with study procedures and assessments\n* Current treatment with medications that significantly affect bone metabolism, including bisphosphonates, denosumab, teriparatide, or other anti-osteoporotic agents\n* Refusal or inability to provide written informed consent",{"count":295,"type":22},98,"Osteoporosis is a major cause of morbidity and fragility fractures in postmenopausal women. Bone mineral density (BMD) alone may not fully reflect fracture risk and skeletal fragility. Lumican, an extracellular matrix proteoglycan involved in collagen organization and musculoskeletal tissue homeostasis, has emerged as a potential biomarker for bone health. This prospective observational study aims to investigate the relationship between serum lumican levels, bone mineral density, muscle strength, and clinical fragility indicators in postmenopausal women. Approximately 100 participants will undergo routine osteoporosis assessment including DEXA, laboratory testing, FRAX evaluation, and handgrip strength measurement. The study will evaluate whether serum lumican levels can identify a hidden fragility phenotype beyond conventional bone mineral density measurements.",[28,298,299,300],"Postmenopausal Osteoporosis","Frailty","Fragility Fractures",[302,28,303,304],"Lumican","Fragility","FRAX","2026-06-24",{"date":307,"type":33},"2026-06-30",{"date":309,"type":33},"2026-05-15",{"date":311,"type":22},"2026-12-01",{"name":313,"class":40},"Kanuni Sultan Suleyman Training and Research Hospital",{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":324,"conditions":325,"keywords":328,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":97},"100644834","functional-muscle-bone-incongruity-index-fkui-a-prospective-observational-study-100644834","NCT07677033","Functional Muscle-Bone Incongruity Index (FKUI): A Prospective Observational Study","Functional Muscle-Bone Incongruity Index (FKUI): Combined Evaluation of Handgrip Strength, Total Hip Bone Mineral Density, and Lumbar-Hip Bone Mineral Density Discordance in Adults Undergoing DXA","FKUI","Inclusion Criteria:\n\n* Age 18 years or older\n* Attendance at the Physical Medicine and Rehabilitation outpatient clinic\n* Scheduled to undergo routine bone mineral density assessment by DXA as part of clinical evaluation\n* Ability to perform handgrip strength testing\n* Availability of lumbar spine and total hip bone mineral density measurements suitable for analysis\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Secondary causes of osteoporosis (e.g., hyperparathyroidism, Cushing syndrome, malignancy, or other conditions affecting bone metabolism)\n* History of metabolic bone disease\n* Major trauma or fracture within the previous 6 months\n* Upper extremity disorders that may significantly affect handgrip strength measurement (e.g., severe osteoarthritis, neurological disorders, major deformities)\n* DXA measurements that are technically inadequate or unsuitable for analysis\n* Refusal or inability to provide written informed consent",{"count":323,"type":22},200,"The Functional Muscle-Bone Incongruity Index (FKUI) is a novel approach developed to evaluate the relationship between muscle function and bone health. This prospective observational study aims to investigate the clinical applicability of FKUI, which combines handgrip strength, total hip bone mineral density (BMD), and lumbar-hip BMD discordance. Approximately 200 adult participants undergoing routine DXA assessment will be enrolled. The study will examine whether the combined evaluation of muscle function and bone health parameters provides a more comprehensive assessment of musculoskeletal status than individual measures alone.",[28,326,327,139],"Musculoskeletal Health","Sarcopenia",[329,320,330,331,332],"Functional Muscle-Bone Incongruity Index FKUI","Bone Mineral Density","Hip-Spine Discordance","Handgrip Strength",{"date":307,"type":33},{"date":335,"type":33},"2026-05-01",{"date":337,"type":22},"2027-05-01",{"name":313,"class":40},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":18,"minAge":133,"maxAge":347,"enrollmentInfo":348,"targetDuration":4,"studyType":80,"phases":350,"briefSummary":351,"conditions":352,"keywords":354,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":70},"100644098","safety-and-efficacy-clinical-trial-of-the-vessel-x-bone-filling-container-system-100644098","NCT07665424","Safety and Efficacy Clinical Trial of the Vessel-X® Bone Filling Container System","The Clinical Investigation to Evaluate the Safety and Efficacy of Vessel-X® Bone Filling Container System","CMT-VX","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for enrollment in this study:\n\n1. Male or female subjects aged ≥40 and ≤95 years.\n2. Subjects admitted with vertebral compression fractures (VCFs) caused by osteoporosis or trauma.\n3. Surgical site within the range of T6 to L5.\n4. Subjects with normal vital signs and hepatic and renal function values within 1.5 times the upper limit of normal (ULN), as determined by the investigator to be suitable for study participation.\n5. Subjects willing to comply with the study schedule and all required assessment procedures.\n6. Subjects who are conscious, cognitively intact, and able to provide written informed consent.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Pathological fractures caused by bone diseases, including benign or malignant tumors, tuberculosis, osteomyelitis, endocrine or metabolic bone disorders, or severe degenerative bone diseases.\n2. Active or severe systemic infections.\n3. Metabolic disorders (e.g., calcium metabolism disorders), immune system disorders, substance abuse, or alcoholism.\n4. Severe primary diseases involving the hematopoietic or endocrine systems, or psychiatric disorders.\n5. History of allergy to implant materials, hypersensitivity reactions, or allergies to multiple medications.\n6. Non-viable bone surrounding the surgical site or insufficient bone quality to support the implant.\n7. Active infection at or adjacent to the surgical site.\n8. Acute spinal instability.\n9. Unwillingness or inability to restrict physical activity or comply with medical instructions.\n10. Considered unsuitable for study participation by the investigator, or unable to provide independent informed consent.","95 Years",{"count":349,"type":22},146,[82],"Osteoporotic vertebral compression fractures (OVCFs) are a common and serious complication of osteoporosis, particularly among elderly and postmenopausal patients. OVCFs may result in severe pain, functional impairment, spinal deformity, and reduced quality of life. Conventional conservative treatments, including bed rest, analgesics, and bracing, may provide limited symptom relief. Minimally invasive vertebral augmentation procedures, such as vertebroplasty and kyphoplasty, have been widely used to improve clinical outcomes; however, risks including bone cement leakage and incomplete vertebral restoration remain concerns.\n\nThe Vessel-X® Bone Filling Container System, manufactured by Central Medical Technologies Inc. (CMT), is a third-generation vesselplasty technology designed for percutaneous vertebral augmentation procedures. The system utilizes an implantable biocompatible polyethylene terephthalate (PET) container with a microporous structure for controlled bone cement delivery. The implant remains within the vertebral body after cement injection and is designed to reduce cement leakage while maintaining vertebral height restoration and pain relief.\n\nThis post-market clinical study evaluates the safety and clinical effectiveness of the Vessel-X® Bone Filling Container System at two medical centers in Taiwan with a total target enrollment of 146 subjects:\n\nTri-Service General Hospital (TSGH): 86 subjects randomized in a 1:1 ratio to the experimental and control groups.\n\nTaoyuan General Hospital, Ministry of Health and Welfare (TYGH): 60 subjects randomized in a 1:1 ratio to the experimental and control groups.\n\nThe primary objective is to evaluate the safety of the device by assessing the incidence of unanticipated serious adverse device effects (USADEs). Secondary objectives include evaluation of pain reduction measured by the Visual Analogue Scale (VAS), functional recovery assessed by the Oswestry Disability Index (ODI), and radiographic outcomes including vertebral height restoration and kyphotic deformity correction.",[28,353],"Osteoporotic Vertebral Compression Fractures",[355,356,357,358,359,360,361,362,363],"Oswestry Disability Index","Visual Analogue Scale","Serious Adverse Device Effect","Last Observation Carry Forward","CMT Vessel-X® Bone Filling Container System","Vesselplasty","Kyphoplasty","Vertebroplasty","Osteoporotic vertebral compression fractures (OVCFs)","2026-06-22",{"date":305,"type":33},{"date":367,"type":33},"2021-04-20",{"date":369,"type":22},"2026-12-31",{"name":371,"class":40},"Juin-Hong Cherng",{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":132,"minAge":165,"maxAge":50,"enrollmentInfo":379,"targetDuration":4,"studyType":80,"phases":381,"briefSummary":382,"conditions":383,"keywords":385,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":97},"100588188","phase-4-effects-of-cycle-therapy-vs-sequential-therapy-with-romosozumab-and-denosumab-in-postmenopausal-osteoporosis-patients-100588188","NCT06938152","Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients","Effects of Cycle Therapy With Romosozumab and Denosumab 2 Years vs 1 Year Romosozumab Followed by 1 Year Denosumab in Postmenopausal Osteoporosis Patients-A Randomized Control Trial","Inclusion Criteria:\n\n* 1\\. Postmenopausal women aged 50-90 years\n* 2\\. BMD T-score ≤ -3.0 at any lumbar vertebra\n* 3\\. Physically and mentally capable of understanding and complying with the study protocol and follow-up\n* 4\\. Signed informed consent\n\nExclusion Criteria:\n\n* 1\\. Previous osteoporosis treatment within the past two years, including Romosozumab, Teriparatide, Denosumab, Alendronate, Ibandronate, Zoledronic Acid, Risedronate, Raloxifene, or Bazedoxifene\n* 2\\. Allergy to Romosozumab or Denosumab\n* 3\\. Secondary osteoporosis\n* 4\\. Autoimmune disease\n* 5\\. Chronic steroid use (e.g., Chronic Obstruction Pulmonary Disease patients)\n* 6\\. Hypercalcemia or hypocalcemia\n* 7\\. Metabolic bone diseases\n* 8\\. Primary or metastatic bone tumors\n* 9\\. Cancer patients (except for in situ carcinoma and non-melanoma skin cancer, unless fully treated and in remission for five years)\n* 10\\. Planned dental procedures (e.g., extractions, implants) within the next year\n* 11\\. History of stent placement, myocardial infarction, stroke, or coronary artery disease\n* 12\\. Renal disease (Creatinine \\> 1.5 mg\u002FdL) or dialysis patients\n* 13\\. Smoking more than one pack per day (except for those who have quit for over ten years)",{"count":380,"type":22},70,[275],"This study is a prospective, randomized, controlled clinical trial comparing the efficacy of a 24-month cyclic therapy regimen (6 months of Romosozumab followed by 6 months of Denosumab, repeated for two years) versus a traditional sequential treatment regimen (12 months of Romosozumab followed by 12 months of Denosumab). The goal is to determine which approach yields better therapeutic outcomes and to optimize drug strategies for osteoporosis patients.",[28,384],"Osteoporosis Postmenopausal",[386,387,388,389,390,391],"postmenopausal","Romosozumab","Denosumab","cycle therapy","Bone mineral density","Bone turnover marker","2026-06-21",{"date":394,"type":33},"2026-06-23",{"date":396,"type":33},"2025-04-08",{"date":398,"type":22},"2029-12-31",{"name":400,"class":40},"National Taiwan University Hospital",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":18,"minAge":165,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":80,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":419,"leadSponsor":421,"locationsCount":97},"100641583","link-between-ascorbemia-level-and-osteoporosis-100641583","NCT07660484","Link Between ASCorbemia Level and Osteoporosis","ASCO Study: Link Between ASCorbemia Level and Osteoporosis","ASCO","Inclusion Criteria:\n\n* Men aged 50 yars or older ;\n* Postmenopausal women ;\n* Afilliated with a health insurance and system ;\n* Written informed consent obtained.\n* Group 1 : Clincal osteoporotic vertebral fracture confirmed by imaging within the previous month ; Followed in the Rheumatology department for management of vertebral fracture.\n* Group 2 : Densitometric osteoporosis (T-score ≤ -2.5) ; No history of severe osteoporotic fracture ; No history of clinical or morphometric vertebral fracture.\n\nExclusion Criteria:\n\n* Legal protection measure (guardianship, curatorship);\n* inability to provide informed consent ;\n* refusal to participate ;\n* Vertebral fracture related to tumor,\n* infection, trauma or non osteoporotic causes ;\n* asymptomatic vertebral fracture discovered incidentally ;\n* Severe densitometric osteoporosis for group 2 ;\n* Previous severe osteoporotic fracture for group B.",{"count":410,"type":22},40,[82],"This monocentric observational study aims to evaluate the association between plasma vitamin C levels (ascorbemia) and the presence of osteoporotic vertebral fractures in patients with osteoporosis. Forty participants will be enrolled at the Rheumatology",[28,414,415],"Vitamin C Deficiency","Vertebral Fractures","2026-06-16",{"date":364,"type":33},{"date":278,"type":22},{"date":420,"type":22},"2028-01-01",{"name":422,"class":40},"Centre Hospitalier Universitaire de Nice",{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":431,"conditions":432,"keywords":435,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":444,"locationsCount":97},"100642638","radiographic-cortical-thickness-of-the-humerus-in-detecting-post-stroke-regional-bone-loss-100642638","NCT07651306","Radiographic Cortical Thickness of the Humerus in Detecting Post-Stroke Regional Bone Loss","Inclusion Criteria:\n\n* Patients aged 18 years and older.\n* A documented history of a single unilateral stroke that occurred at least 6 months prior to evaluation.\n* Presence of clinical hemiparesis.\n* Availability of concurrent standard anteroposterior (AP) shoulder radiographs taken within 6 months post-stroke alongside systemic DXA measurements.\n\nExclusion Criteria:\n\n* History of surgical intervention in either shoulder. History of a proximal humerus fracture.\n* Co-existing metabolic bone diseases, such as primary hyperparathyroidism or osteomalacia.\n* History of malignancy.\n* Documented history of corticosteroid use.\n* Imaging artifacts that compromise the accuracy of DXA measurements.\n* History of a secondary stroke.",{"count":430,"type":22},65,"Post-stroke immobilization and reduced weight-bearing frequently lead to significant regional bone mineral density loss and asymmetry, particularly in the paretic upper extremity, which increases fracture risks. While Dual-Energy X-ray Absorptiometry (DXA) is the gold standard for evaluating systemic bone loss, it primarily focuses on axial or lower extremity sites and lacks universal accessibility. Since routine shoulder radiographs offer an opportunistic screening tool to evaluate regional bone quality without additional radiation , this study aims to compare proximal humerus cortical bone thickness between the paretic and non-paretic sides in stroke patients and assess its correlation with systemic DXA values to determine its clinical utility.\n\nThis cross-sectional, observational study involves a retrospective data analysis of patients aged 18 and older who experienced a single unilateral stroke at least 6 months prior and present with clinical hemiparesis. Eligible participants must have concurrent standard anteroposterior shoulder radiographs and DXA measurements available from their routine clinical follow-ups. Patient demographic data, stroke characteristics, Brunnstrom stages, and systemic DXA measurements (femoral neck and lumbar spine T-scores and bone mineral density values) are systematically recorded for analysis.\n\nCortical bone thickness measurements are performed using ImageJ software on standard radiographs at points 10 cm and 12 cm distal to the highest point of the humerus. To ensure reliability, measurements for both the paretic and non-paretic sides are conducted independently by two researchers who are completely blinded to the DXA results. Statistical analyses, including paired t-tests or Wilcoxon tests and Pearson or Spearman correlations, will be used to compare the sides and evaluate the relationship between radiographic cortical thickness and systemic bone density.",[433,434,28],"Hemiparesis After Stroke","Dual Energy X-ray Absorptiometry",[436,437,28,438],"Stroke","Cortical Bone Thickness","Radiography","2026-06-12",{"date":416,"type":33},{"date":442,"type":33},"2026-02-22",{"date":278,"type":22},{"name":445,"class":446},"Istanbul Physical Medicine Rehabilitation Training and Research Hospital","OTHER_GOV",{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":18,"minAge":454,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":80,"phases":456,"briefSummary":457,"conditions":458,"keywords":460,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":97},"100643506","robot-assisted-minimally-invasive-treatment-versus-conventional-surgery-for-ffp3-4-fragility-fractures-of-the-pelvis-in-elderly-patients-100643506","NCT07639619","Robot Assisted Minimally Invasive Treatment Versus Conventional Surgery for FFP3-4 Fragility Fractures of the Pelvis in Elderly Patients","Comparing the Efficacy and Safety of Robot Assisted Minimally Invasive Treatment Versus Conventional Surgery in Elderly Patients With FFP3-4 Fragility Fractures of the Pelvis","Inclusion Criteria:\n\n* Age ≥ 60 years\n* Low energy trauma\n* Diagnosis of osteoporosis\n* Diagnosis of FFP3 or FFP4 fragility fractures of the pelvis\n* Injury duration less than 3 weeks\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Severe open injury or skin infection at the surgical site\n* Hemodynamic instability preventing anesthesia or surgery\n* Severe psychiatric disorders or dementia\n* Severe obesity affecting imaging quality\n* Severe systemic diseases preventing surgery\n* Pathological fracture\n* Current chemotherapy, radiotherapy, systemic corticosteroid therapy, or growth factor therapy","60 Years",{"count":167,"type":22},[82],"This prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted minimally invasive treatment versus conventional surgery in elderly patients with FFP3-4 fragility fractures of the pelvis. Eligible patients will be stratified according to FFP classification and randomly assigned in a 1:1 ratio to receive either robot assisted minimally invasive fixation or conventional surgical treatment. Primary and secondary outcomes include pain relief, early mobilization, functional recovery, perioperative complications, venous thromboembolism events, laboratory parameters, imaging outcomes, and healthcare resource utilization. The study aims to provide evidence for optimizing surgical treatment strategies in elderly patients with unstable pelvic fragility fractures.",[459,28],"Fragility Fractures of the Pelvis (FFP)",[461,462,463],"Fragility Fracture","Robot Assisted Surgery","pelvis","2026-06-09",{"date":466,"type":33},"2026-06-10",{"date":468,"type":22},"2026-06-01",{"date":470,"type":22},"2028-12-30",{"name":472,"class":40},"Junbo Liang",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":480,"enrollmentInfo":481,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":483,"conditions":484,"keywords":485,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":492,"locationsCount":4},"100642349","clinical-study-on-a-new-diagnostic-strategy-for-osteoporosis-and-sarcopenia-in-chronic-kidney-disease-patients-based-on-mri-ff-100642349","NCT07645794","Clinical Study on a New Diagnostic Strategy for Osteoporosis and Sarcopenia in Chronic Kidney Disease Patients Based on MRI-FF","A Clinical Study on Establishing a New Diagnostic Strategy for Osteoporosis and Sarcopenia in Patients With Chronic Kidney Disease Based on MRI-FFR","Inclusion Criteria:\n\n1. Age between 18 and 80 years old.\n2. Able to understand and sign the informed consent form.\n3. Able to complete MRI-FF scans of the lumbar spine and thigh.\n4. For CKD group: Confirmed diagnosis of chronic kidney disease (eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m² for ≥3 months).\n5. For control group: No history of chronic kidney disease and normal renal function.\n\nExclusion Criteria:\n\n1. Contraindications to MRI (e.g., pacemaker, metal implants, severe claustrophobia).\n2. History of primary bone metabolic disorders (e.g., osteoporosis, hyperparathyroidism) unrelated to CKD.\n3. Current use of anti-osteoporotic drugs (e.g., bisphosphonates, teriparatide).\n4. Severe lower limb deformity or amputation affecting thigh muscle assessment.\n5. Inability to cooperate with the scan due to cognitive impairment or severe illness.","80 Years",{"count":482,"type":22},868,"This is a single-center, observational cohort study aiming to validate the diagnostic value of MRI-FF in identifying osteoporosis and sarcopenia in patients with chronic kidney disease (CKD). A total of 868 participants, including 434 CKD patients and 434 non-CKD controls, will be enrolled at Beijing Jishuitan Hospital. All subjects will undergo MRI-FF scans of the lumbar spine and thigh to assess bone mineral density and muscle fat fraction. The primary objective is to evaluate the correlation between MRI-FF parameters and conventional diagnostic criteria for osteoporosis and sarcopenia, as well as to determine the optimal cut-off values for early detection. The study duration is from March 2026 to December 2028.",[195,28],[195,28,327,486,330,487],"MRI-FF","Muscle Fat Fraction",{"date":439,"type":33},{"date":490,"type":22},"2026-06",{"date":67,"type":22},{"name":493,"class":40},"Capital Medical University",{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":18,"minAge":501,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":80,"phases":504,"briefSummary":505,"conditions":506,"keywords":507,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":97},"100640773","people-with-osteoporosis-can-walk-best-to-reduce-fall-and-fracture-risk-100640773","NCT07621679","People With Osteoporosis Can Walk-BEST to Reduce Fall and Fracture Risk","Walk-BEST","Inclusion Criteria:\n\n* men and women 70 years and older\n* able to walk independently with or without a walking aid\n* experienced a prior fracture after the age of 40, OR two falls in the past 12 months, OR who have a bone mineral density test (done as part of routine clinical evaluation) with a T-score \\\u003C -2.5, OR on a Health Canada-approved anti-osteoporosis medication (oral or intravenous bisphosphonate, denosumab, teriparatide, or romozosumab) to reduce fracture risk or on a bisphosphonate drug holiday (planned treatment interruption)\n\nExclusion Criteria:\n\n* fracture sustained in the past 12 months\n* unable to walk unsupervised because of active medical or neurocognitive reasons\n* unable to provide informed consent, or cannot communicate in English or French","70 Years",{"count":503,"type":22},28,[82],"The aim of the Walk BEST study is to provide evidence that it is feasible to implement the technology assisted gait- focused walking program Walk-BEST™ in older adults with osteoporosis, and that this program is acceptable to this population.",[28],[508,509,510,511,512],"Gait","Wearable","Walking","Falls","Fracture Risk","2026-05-29",{"date":515,"type":33},"2026-06-02",{"date":517,"type":33},"2026-05-07",{"date":519,"type":22},"2027-05",{"name":521,"class":40},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":17,"sex":18,"minAge":133,"maxAge":480,"enrollmentInfo":528,"targetDuration":4,"studyType":80,"phases":530,"briefSummary":531,"conditions":532,"keywords":533,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":239},"100638403","artificial-intelligence-guided-diagnosis-for-high-risk-osteoporosis-populations-a-pragmatic-randomized-clinical-trial-100638403","NCT07620834","Artificial Intelligence-Guided Diagnosis for High-Risk Osteoporosis Populations: A Pragmatic Randomized Clinical Trial","Inclusion Criteria:\n\n* Aged between 40 to 80 years old\n* Identified as high-risk by the Osteoporosis Self-Assessment Tool for Taiwan Postmenopausal Women (OSTAi) \\\u003C-1 or Male Osteoporosis Self-Assessment Tool for Taiwan (MOSTAi) ≦11 based on the individual's age and weight (kg)\n* Had chest x-ray within one year\n\nExclusion Criteria:\n\n* Age \\\u003C 40 years old\n* Age \\>80 years old\n* BMI\\\u003C 18 kg\u002Fm2or \\>30 kg\u002Fm2\n* Pregnant in prior one year\n* Recorded diagnosis of osteoporosis within the past two years\n* History of prior DXA imaging (prior quantification of BMD) within 2 years\n* History of metabolic bone disease",{"count":529,"type":22},1180,[82],"Project Summary\n\nI. Project Objectives\n\nWith the rapid advancement of medical technology, smart medical devices have become one of the key components of modern healthcare. However, integrating these emerging technologies into the national health insurance (NHI) reimbursement system while ensuring their clinical value and economic benefits remains a major challenge worldwide.\n\nThe primary goal of this project is to assist commercialized smart medical device products-those that have passed TFDA review and seek NHI reimbursement-in conducting comprehensive evaluations of their clinical effectiveness and medical economic impact. Through scientific data and standardized impact assessment procedures, the project aims to provide localized evidence to support reimbursement policy decisions and facilitate the market adoption of smart medical technologies. Ultimately, this project seeks to balance therapeutic efficacy and cost control, offering a scientific foundation for NHI decision-making and paving the way for the sustainable development of AI-driven healthcare innovations.\n\nII. Implementation Methods\n\n1. Multi-center Collaborative Network\n\n   This project will be led by Taichung Veterans General Hospital (TCVGH) as the principal site, with collaboration from Kaohsiung Medical University Chung-Ho Memorial Hospital and Changhua Show Chwan Memorial Hospital. This cross-institutional, cross-regional alliance ensures diverse clinical samples, enhances the representativeness of study results, and allows evaluation of AI medical devices across different healthcare systems and environments.\n2. Clinical Trial Design and Implementation for Smart Medical Devices\n\n   The project will design and execute systematic clinical trials for smart medical devices using methodologies such as randomized controlled trials (RCTs), before-and-after studies, pragmatic RCTs (PCTs), cluster RCTs, and stepped-wedge RCTs. These rigorous designs will ensure scientific validity, reproducibility, and practical feasibility in real-world clinical settings.\n3. Health Economic Evaluation\n\n   A key component of this project is the medical economic assessment, conducted by experienced health economists through cost-effectiveness analysis. The evaluation will focus on how smart medical devices reduce healthcare costs, improve diagnostic efficiency, and enhance treatment outcomes, quantifying their economic value within the NHI system. This evidence will guide policy makers in making data-driven reimbursement decisions.\n4. Standardized Impact Assessment Process\n\n   To ensure high-quality research, the project will establish a comprehensive standardized impact assessment framework covering trial design, data collection, statistical analysis, economic evaluation, and ethical review. This standardized approach not only improves the precision of the study but also accelerates the clinical translation of AI medical devices through streamlined application and review processes.\n5. Research Case Study and Clinical Application\n\n   The featured case study in this project is \"VeriOsteo OP® Smart Bone Screening System,\" which targets early osteoporosis screening among adults aged 40 to 80 years in high-risk groups. This study will evaluate the clinical accuracy of AI-based osteoporosis screening and assess its economic contribution to healthcare cost reduction. The findings will directly inform the Ministry of Health and Welfare's NHI Administration in formulating reimbursement standards for AI medical devices.\n6. Data Sharing and Information Security\n\n   Throughout the project, all research data collection, exchange, and sharing will strictly adhere to cybersecurity and privacy regulations. The AI models involved will undergo validation to ensure the reliability and scientific rigor of the results. Furthermore, the project will promote collaboration between manufacturers and healthcare institutions to support the adoption of smart medical technologies.\n7. Final Outcomes and Future Development\n\nThe final deliverables will include a comprehensive evaluation report on the clinical and economic performance of the AI medical device, along with recommendations for NHI reimbursement application. The results will provide a reference model for future AI medical devices entering the reimbursement system and further advance the field of smart healthcare. In the long term, the center aims to expand its research to other disease domains while strengthening data security and ethical oversight to ensure the feasibility and credibility of AI applications in clinical practice.\n\nIII. Expected Outcomes and Future Vision\n\nBy implementing a multi-center collaborative framework, this project aims to promote clinical adoption and economic evaluation of smart medical devices, offering concrete data to support NHI policy-making. Over time, the project is expected to establish a robust evaluation system for AI medical devices, facilitate broader market adoption, and enhance patient outcomes whi",[28],[534,535,536,537],"Software as a Medical Device (SaMD)","Clinical Impact Analysis","Health Economics","Standardization of NHI Reimbursement","2026-05-27",{"date":515,"type":33},{"date":541,"type":33},"2026-03-13",{"date":543,"type":22},"2026-11-12",{"name":545,"class":40},"Taichung Veterans General Hospital",{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":18,"minAge":133,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":555,"conditions":556,"keywords":558,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":70},"100558441","peripheral-mononuclear-cells-to-screen-monitor-and-stratify-the-population-at-risk-of-osteoporosis-and-fractures-100558441","NCT06551155","Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures","Identification, Monitoring, and Classification of Patients at Risk of Osteoporosis and Fractures Using a Method Based on the Use of Mononuclear Cells From Peripheral Blood","DISCERN","Inclusion Criteria:\n\n* Healthy patients (at risk and undergoing periodic follow-up and\u002For attending outpatient visits for preventive screening)\n* Osteopenic patients with an available DXA\n* Osteoporotic patients (fractured and non-fractured) with an available DXA or, for fractured patients, a DXA prescribed as part of clinical practice\n* Aged ≥ 40 years of both sexes\n* Body Mass Index (BMI) between 18.5 and 29.9\n\nExclusion Criteria:\n\n* Hematopoietic system disorders (hemolytic, aplastic, and neoplastic anemias)\n* Coagulation disorders (hereditary or secondary to other disorders)\n* Infections (including HIV-HBV-HCV positivity)\n* Neoplastic diseases (primary and\u002For secondary tumors)\n* Pregnancy or breastfeeding\n* Alcohol consumption (\\>20 g of alcohol per day currently or in the past)\n* Smoking (\\>10 cigarettes per day, currently or in the past)\n* Diabetes\n* Treatment with therapeutic agents that may interfere with hematopoiesis (corticosteroids, immunosuppressive agents, cytotoxic drugs)",{"count":21,"type":22},"Osteoporosis (OP) is one of most common age-associated and chronic metabolic bone diseases, featured by a decrease of bone mineral density (BMD) that increases the risk of bone fractures.OP guidelines agree that Dual-X-ray Absorptiometry (DXA) is the gold standard for BMD assessment, but for the different OP stages screening and diagnosis, BMD by itself is not an accurate predictor. Thus, OP is often misdiagnosed. Aim of the this study is to improve a tool for OP diagnosis based on the ability of circulating peripheral blood mononuclear cells (PBMCs) to maintain or not their in vitro viability (IRCCS Istituto Ortopedico Rizzoli European patent n.3008470 March 21, 2018) for the measurement of the different OP severity levels, also considering specific gender related differences.",[28,139,557],"Osteoporosis Fracture",[559,560,561],"peripheral blood mononuclear cells","screening","diagnosis","2026-05-25",{"date":564,"type":33},"2026-05-28",{"date":566,"type":33},"2024-08-05",{"date":568,"type":22},"2027-02-20",{"name":570,"class":40},"Istituto Ortopedico Rizzoli",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":132,"minAge":165,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":80,"phases":581,"briefSummary":582,"conditions":583,"keywords":585,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":70},"100637120","microrna-and-markers-and-therapeutic-response-to-romosozumab-and-abaloparatide-in-postmenopausal-osteoporosis-100637120","NCT07616401","MicroRNA and Markers and Therapeutic Response to Romosozumab and Abaloparatide in Postmenopausal Osteoporosis","MicroRNA and Circulating Markers Predictive of the Therapeutic Response to Romosozumab and Abaloparatide Treatment in Women With Postmenopausal Osteoporosis","ROMIRNA","Inclusion Criteria:\n\n* Female sex\n* Postmenopause\n* Densitometric diagnosis of osteoporosis\n* Normal calcium diet\n* Supplement with cholecalciferol or calcifediol\n\nExclusion Criteria:\n\n* Premenopause\n* Chronic therapy with glucocorticosteroids, or other treatments that may affect bone metabolism\n* Diseases and conditions that may affect bone metabolism",{"count":580,"type":22},42,[82],"Osteoporosis is a systemic skeletal disorder affecting approximately 10% of individuals over 50 years of age. It is characterised by an increased risk of fragility fractures, which constitute a major source of morbidity, mortality, and healthcare burden worldwide.\n\nA range of pharmacological therapies has been approved for osteoporosis, with demonstrated efficacy in reducing fracture risk. These include anabolic agents that stimulate osteoblast-mediated bone formation (teriparatide, abaloparatide), antiresorptive agents that inhibit osteoclast-driven bone resorption (bisphosphonates, denosumab), and dual-action agents such as romosozumab, which, through sclerostin inhibition, simultaneously enhances bone formation and suppresses resorption. In clinical practice, these agents are administered sequentially or in combination to optimise therapeutic outcomes.\n\nThe primary goal of anti-osteoporotic therapy is to reduce the risk of incident and subsequent fractures. In postmenopausal osteoporosis, this objective is closely linked to meaningful gains in bone mineral density (BMD), as measured by dual-energy X-ray absorptiometry (DEXA), with attainment of osteopenic ranges associated with low fracture probability (\\\u003C15% for major osteoporotic fractures and \\\u003C3% for hip fractures, according to FRAX). However, selecting the most effective therapeutic strategy remains challenging, as robust predictors of individual treatment response are lacking. Although bone turnover markers are widely used to monitor treatment effects, their value in predicting clinical outcomes is limited.\n\nMicroRNAs (miRNAs) are small (\\~22 nucleotides), single-stranded, non-coding RNAs that regulate gene expression at the post-transcriptional level through binding to complementary sequences in target mRNAs. Circulating miRNAs are stabilised by association with proteins and extracellular vesicles, making them attractive candidates as biomarkers. Increasing evidence indicates that miRNAs play key roles in osteoblast and osteoclast differentiation, proliferation, and apoptosis, and distinct miRNA expression profiles have been associated with osteoporosis and fragility fractures.\n\nAn emerging area of interest is the interaction between osteoactive therapies and circulating miRNA signatures. To date, available data are largely limited to antiresorptive agents and teriparatide. No studies have yet addressed miRNA expression profiles in patients treated with romosozumab or abaloparatide.\n\nBeyond miRNAs, additional molecular pathways implicated in osteoimmunological crosstalk and ageing are gaining attention as potential biomarkers. Nitric oxide (NO) plays a multifaceted role in bone homeostasis, inhibiting osteoclast activity while promoting osteoblast function. Reduced circulating NO levels have been identified as an independent predictor of osteoporotic fractures in postmenopausal women. Autophagy is increasingly recognised as a critical regulator of bone remodelling, influencing both osteoblastic and osteoclastic activity. Dysregulation of autophagic pathways disrupts bone homeostasis and contributes to bone loss. These processes are tightly controlled by complex molecular networks, including miRNAs, and are closely linked to lysosomal function. In this context, cathepsin K has emerged as a promising therapeutic target in osteoporosis.\n\nThe present study primarily aims to identify circulating microRNAs, whose early treatment-induced changes are predictive of the outcome of the therapy in terms of changes in BMD. Secondary, it aims to identify correlations of the changes in microRNAs serum concentrations with variations in biomarkers of bone metabolism as well as of aging.\n\nThe study enrols women with diagnosis of severe postmenopausal osteoporosis addressed to treatment with romosozumab or with abaloparatide. All women will be assessed at baseline and after 2, 6 and 12 months of treatment.",[28,584],"Menopause",[28,586,587,387,588],"Bone markers","MicroRNA","Abaloparatide","2026-05-23",{"date":468,"type":33},{"date":592,"type":33},"2025-08-31",{"date":594,"type":22},"2029-08-31",{"name":596,"class":40},"Istituto Auxologico Italiano",{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":601,"acronym":602,"eligibilityCriteria":603,"healthyVolunteers":17,"sex":18,"minAge":133,"maxAge":454,"enrollmentInfo":604,"targetDuration":4,"studyType":80,"phases":606,"briefSummary":607,"conditions":608,"keywords":609,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":618,"completionDateStruct":619,"leadSponsor":621,"locationsCount":97},"100640983","osteoporosis-and-sarcopenia-prevention-in-middle-aged-population-100640983","NCT07611097","Osteoporosis and Sarcopenia Prevention in Middle-Aged Population","FORTIFY","Inclusion Criteria:\n\n* General Population: Women and men aged 40-60 years, defined as age groups where the rate of injuries were still relatively lower, thus considered as a low to moderate risk cohort for osteoporosis.\n* Risk profile: Targets a low to moderate risk cohort for osteoporosis (e.g., as defined by no prior fragility fracture and questionnaire). This aligns with the study's primary prevention objective.\n* Individuals with well-controlled comorbidities like hypertension, diabetes, or pre-diabetes can be included in the study program. Exercise and healthy nutritional diets can also help treat their existing health conditions.\n\nExclusion Criteria:\n\n* Significant comorbidities: Individuals with existing (e.g., severe or uncontrolled) medical illness, due to risk to aerobic exercise. This includes, but is not limited to, active ischemic heart disease, unstable angina, uncontrolled hypertension, or other conditions as determined by study physicians.\n* High baseline activity: Individuals who have engaged in \\>4 hours intensive sports per week will be excluded. This population is deemed to be at very low risk, thus would likely derive minimal additional benefit from the intervention, and their inclusion could represent inefficient use of finite resources (e.g., DEXA scanning services).",{"count":605,"type":22},8336,[82],"This initiative is designed to yield substantial and multi-level benefits for the Hong Kong community by pioneering a transformative model of preventive healthcare. It represents the largest randomized controlled trial for osteoporosis and sarcopenia prevention in the region, adopting a comprehensive approach to fracture prevention through innovative fitness, lifestyle, and digital strategies.\n\nThe study's primary objective is to evaluate the efficacy of preventing fractures, osteoporosis, and sarcopenia through an incentivized program of fitness and lifestyle modifications in adults aged 40-60. The secondary objectives include: (1) to validate the use of simple, low-cost measures (grip strength and InBody body composition analysis) as reliable proxy indicators for osteoporosis and sarcopenia risk relative to the gold-standard DEXA scan; (2) to develop a formal, standardized clinical protocol for early detection and prevention, including specified DEXA anatomical measurement sites, for use by healthcare professionals in primary and community care settings; (3) to assess changes in exercise behavior, musculoskeletal health, physical function, health literacy, and participant engagement with the digital (AI chatbot) support system; (4) to analyze the cost-effectiveness of the intervention compared to standard care or pharmacological treatment, including an assessment of healthcare utilization and Quality-Adjusted Life Years (QALYs).\n\nAfter baseline screening and consent, participants are randomly assigned to one of two groups (1:1 ratio) with intention-to-treat principles. The Control Group will receive passive, static support. This involves participating in one initial FUN Day, receiving standard exercise videos, using a passive chatbot for data reporting, undergoing start and end DEXA scans (which require a co-payment), completing a 3-month assessment, and receiving souvenirs at the study start and end. Meanwhile, the Intervention Group will receive active, dynamic support designed to build and reinforce healthy habits. This involves participating in the initial FUN Day, a reinforcement FUN Day at 2 months, nine mandatory structured exercise touchpoints, using an active chatbot with reminders, feedback, and gamification, undergoing start and end DEXA scans (which require a co-payment), completing a 3-month assessment, and receiving ongoing incentives and souvenirs at multiple points. Therefore, researchers will compare between the control and intervention groups to see if intervention can prevent osteoporosis and sarcopenia at a population level.\n\nAll participants will undergo a series of assessments at specific timepoints. This includes two DEXA scans (at the study start and in the fourth year, requiring a participant co-payment), InBody composition analysis, and physical health assessments (e.g., grip strength, balance, cardiovascular fitness). These assessments will be performed at baseline (during the first FUN Day), 3 months, 12 months, 24 months, and 36 months. A long-term follow-up will continue for up to 10 years to monitor adverse health events such as falls and fractures. Participants will also complete questionnaires via an AI chatbot at baseline, 3 months, and annually during follow-up. The collected data will encompass health literacy (e.g., osteoporosis\u002Fsarcopenia knowledge scores), digital engagement (e.g., chatbot responsiveness), and economic outcomes (e.g., incremental cost per Quality-Adjusted Life Year \\[QALY\\] gained). Data analysis will employ appropriate statistical methods to compare outcomes between the control and intervention groups across all assessments and timepoints.",[28,327],[610,611,612,613,614,615],"Randomized Controlled Trial","Middle-Aged Population","Osteoporosis Prevention","Sarcopenia Prevention","AI Chatbot","DEXA Alternative","2026-05-20",{"date":564,"type":33},{"date":468,"type":22},{"date":620,"type":22},"2036-05-31",{"name":622,"class":40},"The University of Hong Kong",{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":629,"eligibilityCriteria":630,"healthyVolunteers":17,"sex":132,"minAge":631,"maxAge":632,"enrollmentInfo":633,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":635,"conditions":636,"keywords":637,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":70},"100536894","clinical-validation-of-bbct-hip-100536894","NCT06270758","Clinical Validation of BBCT-hip","Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction","ValidaBBCT-hip","Inclusion Criteria:\n\n* caucasic post-menopausal women resident in Emilia-Romagna\n* menopause (\\>= 45 years)\n\nExclusion Criteria:\n\n* tumours\n* not free living\n* Chronic diseases with severe organ failure \u002F endocrine diseases of parathyroid, thyroid, adrenal gland \u002F intestinal malabsorption, osteomalacia \u002F Paget bone \u002F rheumatoid arthritis. Neurodegenerative diseases\n* Long-term continuous therapy (\\>3 months) with corticosteroids and proton pump inhibitors or aromatase inhibitors\n* Previous femur fractures\n* Presence of hip\u002Fknee prosthesis\n\nonly for the fracturegroup:\n\n* presence of fixation devices after the fracture\n* femur fracture due to high energy trauma","65 Years","85 Years",{"count":634,"type":22},300,"The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study.",[28],[638,639,640,641,642],"hip fracture","fracture prediction","finite element","in silico","osteoporotic fracture",{"date":644,"type":33},"2026-05-22",{"date":646,"type":33},"2023-11-07",{"date":648,"type":22},"2030-11-06",{"name":570,"class":40},{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":656,"eligibilityCriteria":657,"healthyVolunteers":17,"sex":18,"minAge":454,"maxAge":4,"enrollmentInfo":658,"targetDuration":4,"studyType":80,"phases":659,"briefSummary":660,"conditions":661,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":664,"lastUpdatePostDateStruct":665,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":669,"locationsCount":97},"100459773","mode-of-exercise-and-bone-biomarkers-in-older-veterans-100459773","NCT05266976","Mode of Exercise and Bone Biomarkers in Older Veterans","Anabolic Versus Catabolic Skeletal Effects of Endurance or Resistance Exercise in Older Veterans","MOVE","Inclusion Criteria:\n\n* Healthy older (60+ y) Veteran women and men in the Denver Metro Area\n* Normally active (e.g., recreational cycling or walking exercise)\n\nExclusion Criteria:\n\n* Impaired renal function, defined as an eGRF of \\\u003C60 mL\u002Fmin\u002F1.73m2\n* Hepatobiliary disease, defined as liver function tests (AST, ALT) \\>1.5 times the upper limit of normal\n* Thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH) \\\u003C0.5 or \\>5.0 mU\u002FL\n* Serum Ca \\\u003C8.5 or \\>10.3 mg\u002FdL\n* Serum 25(OH)D \\\u003C20 ng\u002FmL\n* Uncontrolled hypertension, defined as resting systolic blood pressure (BP) \\>150 mmHg or diastolic BP \\>90 mmHg;\n* History of type 1 or type 2 diabetes\n* Cardiovascular disease, defined as subjective or objective indicators of ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test (GXT). Volunteers who have a positive GXT can be re-considered after follow-up evaluation, which must include diagnostic testing (e.g., stress echocardiogram or thallium stress test) with interpretation by a cardiologist\n* Anemia, defined as a serum hemoglobin \\\u003C12.1 g\u002FdL for women and \\\u003C14.3 g\u002FdL for men\n* Fracture in the past 6 months\n* Current diagnosis or symptoms of COVID-19\n\nIn the event of abnormal BP, live function, TSH, 25(OH)D, or hemoglobin values, volunteers can be reassessed, including after appropriate follow-up evaluation and treatment by a primary care provider. Those who have experienced symptoms of COVID-19 or have been formally diagnosed will be allowed to participate once symptoms have resolved and they are approved to return to exercise by their primary care provider.",{"count":21,"type":22},[82],"Adults are often encouraged to exercise to maintain or improve bone health. However, there is evidence that exercise does not always lead to increases in bone mass, and exercise could lead to bone loss under certain conditions. Endurance exercise can increase bone resorption following an exercise bout, which may explain why bone does not always favorably adapt to exercise, but it is unclear if this also happens with resistance exercise. Further, it is not known how exercise training influences blood markers of bone resorption for either endurance or resistance exercise. The purpose of this study is to determine 1) if resistance exercise causes a similar increase in bone resorption as endurance exercise; and 2) if exercise training influences the increase in bone resorption following exercise for both endurance and resistance exercise.",[662,663,28],"Aging","Musculoskeletal Diseases","2026-05-19",{"date":644,"type":33},{"date":667,"type":33},"2022-07-06",{"date":178,"type":22},{"name":670,"class":671},"VA Office of Research and Development","FED"]