[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteoporosis-in-post-menopausal-women\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteoporosis-in-post-menopausal-women":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,84,112],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100652358","phase-4-sequential-treatment-with-romosozumab-followed-by-denosumab-vs-zoledronic-acid-for-gains-in-hip-bmd-100652358",false,"NCT07772609","Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD","Short-course Romosozumab Followed by Denosumab Versus Zoledronic Acid: A Multicentre Randomized Active-controlled Trial in Postmenopausal Women at High Fracture Risk","STRONG-HIP","Inclusion Criteria:\n\n1. The subject is a postmenopausal woman aged 60 years or older at screening.\n2. The subject has provided written informed consent before any trial-specific procedure is performed.\n3. The subject has osteoporosis at screening defined as a T-score of -2.5 or lower at the total hip or lumbar spine (L1-L4) on central reader confirmed bone densitometry by DXA.\n4. The subject is at high fracture risk, defined by at least one of the following: a previous low-trauma fracture after age 50 years (excluding skull, face, fingers and toes); FRAX probability at or above the age-specific Swedish intervention threshold (using Nordic and Nordic borne calculations, as appropriate) in use at screening.\n5. Corrected plasma calcium or ionized calcium is within the local reference range before randomization.\n6. Serum 25-hydroxyvitamin D concentration ≥50 nmol\u002FL before randomization.\n7. Adequate renal function for zoledronic acid treatment, defined as creatinine clearance ≥35 mL\u002Fmin calculated using the clinical trial center specified calculation procedure (e.g. the Cockcroft-Gault equation) before randomization.\n8. The subject is able and willing, in the investigator's judgment, to comply with the trial procedures and attend scheduled visits.\n9. For participants entering the extension, separate written extension consent is obtained before any extension-specific procedure is performed.\n\nExclusion Criteria:\n\n1. Severe osteoporosis, defined as total hip or lumbar spine T-score \\\u003C -3.5 and\u002For prevalent grade 2 or grade 3 vertebral fracture.\n2. Previous myocardial infarction or stroke at any time before screening.\n3. Transient ischemic attack, unstable angina, coronary or major peripheral revascularization within 12 months before screening, decompensated heart failure, uncontrolled clinically relevant arrhythmia, or any cardiovascular condition that in the investigator's judgment confers unacceptably high risk of a major adverse cardiovascular event during study participation.\n4. Use of intravenous bisphosphonate therapy or teriparatide within 3 years before randomization.\n5. Use of oral bisphosphonate or denosumab within 12 months before randomization.\n6. Any previous use of romosozumab.\n7. Use of systemic estrogen, selective estrogen receptor modulator within 3 months.\n8. Use of oral glucocorticoids for more than 14 consecutive days during the 6 months before screening.\n9. Known metabolic bone disease other than postmenopausal osteoporosis, including but not limited to Pagets disease, osteomalacia, untreated hyperparathyroidism, osteogenesis imperfecta, or active renal osteodystrophy.\n10. Creatinine clearance below 35 mL\u002Fmin, rapidly deteriorating renal function, or another renal condition that makes zoledronic acid unsafe.\n11. Hypocalcaemia (ionized calcium \\\u003C1.15 mmol\u002Fl or total albumin corrected calcium of \\\u003C2.15 mmol\u002Fl) or vitamin D 25-OH-vit-D \\\u003C50nmol\u002Fl, not corrected before randomization.\n12. Unexplained serum alkaline phosphatase \\>2 times the local upper limit of normal.\n13. Malignancy within the last 5 years, except adequately treated basal-cell carcinoma of the skin, squamous-cell carcinoma in situ of the skin, or cervical carcinoma in situ.\n14. Current osteonecrosis of the jaw, unhealed oral or jaw lesions, active dental or jaw infection, or planned invasive dental extraction\u002Fimplant procedure that has not been completed and healed before randomization, if considered by the investigator to represent a contraindication or unacceptable risk for treatment with romosozumab, denosumab or zoledronic acid.\n15. Known hypersensitivity or contraindication to romosozumab, denosumab, zoledronic acid, calcium supplementation, or vitamin D supplementation that cannot be safely managed under the protocol.\n16. Inability to undergo protocol DXA\u002FVFA reliably, for example because of body habitus exceeding scanner limits, inability to position safely, or interfering hardware or artefacts that prevent valid endpoint assessment.\n17. Current participation, or recent participation within 30 days or five half-lives (whichever is longer), in another interventional clinical trial that could affect safety or data interpretation.\n18. Any other medical, psychiatric, social or logistical condition that, in the investigators opinion, makes participation unsafe or would compromise protocol adherence or data reliability.","FEMALE","60 Years",{"count":20,"type":21},216,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Osteoporosis is associated with a high risk of fractures, disability, loss of independence, and excess mortality. Zoledronic acid is an established first-line treatment in Sweden, but many patients at high fracture risk remain at substantial residual fracture risk. Short-course treatment with romosozumab followed by denosumab produces large increases in bone mineral density, but has not been directly compared with zoledronic acid.\n\nSTRONG-HIP is a multicentre, randomized, active-controlled phase 4 trial in 216 postmenopausal women aged 60 years or older with osteoporosis and high fracture risk. Participants are randomized 1:1 to receive romosozumab 210 mg monthly for 3 months followed by denosumab 60 mg every 6 months, or zoledronic acid 5 mg intravenously at baseline and Month 12.\n\nThe primary objective is to determine whether the romosozumab-denosumab sequence produces a greater percentage increase in total hip bone mineral density from baseline to Month 24 than zoledronic acid. Secondary outcomes include total hip and lumbar spine BMD at earlier time points, vertebral and clinical fractures, bone turnover markers, safety, health-related quality of life, and health-economic outcomes. A mechanistic substudy will assess bone microarchitecture and estimated strength using HR-pQCT.\n\nParticipants are followed for 24 months in the main study and may enter an optional extension with follow-up to Month 48 to assess the durability of treatment effects.",[27],"Osteoporosis in Post-menopausal Women",[29,30,31,32,33,34,35,36,37],"Randomized controlled trial","Romosozumab","Denosumab","High resolution peripheral computed tomography","Bone mineral density","Zoledronic acid","Postmenopausal","Osteoporosis","Fracture risk","NOT_YET_RECRUITING","2026-08-18",{"date":41,"type":42},"2026-08-19","ACTUAL",{"date":44,"type":21},"2027-01-11",{"date":46,"type":21},"2031-12-31",{"name":48,"class":49},"Sahlgrenska University Hospital","OTHER",9,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100613494","bone-health-in-postmenopausal-women-the-effect-of-exercise-with-or-without-medication-for-osteoporosis-100613494","NCT07267325","Bone Health in Postmenopausal Women: The Effect of Exercise With or Without Medication for Osteoporosis","The Effect of Exercise With or Without Antiresorptive Therapy, on Bone Properties in Postmenopausal Women With Low BMD - Randomised Controlled Unilateral Intervention Trial","BEAT-OP","Inclusion Criteria:\n\n* Women aged 55-75 years old\n* \\>4y since menopause\u002Fhysterectomy\u002Foophorectomy.\n* Baseline femoral neck or lumber spine BMD T-score between -1 and -3.\n* Able to complete the hopping exercises.\n* Have no regular involvement for more than once\u002Fweek in:\n\n  1. Strength, powerlifting or high load resistance exercise.\n  2. High to moderate impact exercise that known to involve ground reaction forces 2 to 4 times greater than body weight (e.g. Jogging).\n* Treatment group: taking antiresorptive treatment for osteoporosis continuously for at least 12 months, and who intend to continue this medication for the rest of the study.\n* Control group: not taking any medication affecting bone and no intention to commence such medication for the rest of the study.\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\>35 kg\u002Fm2\n* Any medical condition, surgery, or injuries that contraindicate exercises including lower limb or back pain, knee or hip osteoarthritis.\n* Vertebral fracture or multiple low trauma fractures (recent expert consensus recommends lower impact exercise for these groups)\n* Replacement of hip joint(s)",true,"55 Years","75 Years",{"count":63,"type":21},110,[65],"NA","Osteoporosis is a systemic bone disorder characterised by a reduced bone mass and structural deterioration, increasing the risk of fragility fractures, particularly in women post-menopause. Bone mass and structure can be assessed by scans.\n\nAntiresorptive medications are commonly prescribed to reduce bone resorption, preventing further bone loss and thus reducing the possibility of fracture. Exercise can also benefit bone mass and structure but current evidence do not show whether exercise is more, or less, effective in combination with antiresorptive medication.\n\nThis study will compare the effect of a brief, home-based exercise programme on bone mineral and structural properties in women taking\u002F not taking antiresorptive medication.",[27],[69,33,70,71,37,72,73],"Exercise","Bone strength","Bone geometry","Bone structure","Biomarkers","2025-12-04",{"date":76,"type":42},"2025-12-05",{"date":78,"type":21},"2026-01-01",{"date":80,"type":21},"2027-09",{"name":82,"class":49},"Loughborough University",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100582501","phase-4-a-clinical-study-on-the-effect-of-discontinuing-alendronate-in-postmenopausal-women-with-osteoporosis-after-a-treatment-period-without-fractures-100582501","NCT06864130","A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women With Osteoporosis After a Treatment Period Without Fractures","The Alendronate Discontinuation Study","ALEXIS","Inclusion Criteria:\n\n* Female\n* Postmenopausal\n* Current treatment with Alendronate\n* Alendronate treatment \\>3 år AND no fracture OR\n* Alendronate treatment \\>5 år AND latest low energy fracture \\> 3 years ago\n\nExclusion Criteria:\n\n* T-score \\\u003C - 3,5 in hip (total hip or femoral neck) or lumbar spine\n* Treatment with systemic glucocorticoids, ongoing or within 12 months\n* Uncontrolled inflammatory disease\n* Active malignancy\n* eGFR \\\u003C 40 mL\u002Fmin\n* Atypical femur fracture (ever)\n* OsteoNecrosis of the Jaw (active)\n* Unable to give inform consent",{"count":93,"type":21},1400,[24],"The goal of this clinical trial is to study the effects of discontinuation of Alendronate treatment for three years. The participants are postmenopausal women with osteoporosis, who have had a treatment period without fractures. The study will answer:\n\n* What is the rate of fragility fractures during the study? The hypothesis is that discontinuation of Alendronate after a fracture-free period does not raise the 3-year fracture risk.\n* Are there predictors of significant bone loss after discontinuation of Alendronate? The hypothesis is that clinical, biochemical, cellular, or molecular characteristics can predict bone loss.\n\nResearchers will compare the outcomes of discontinuation of Alendronate with continuing treatment. Participants will be randomly assigned to a group.\n\nParticipants will:\n\n* Either take alendronate once weekly for three years OR discontinue their treatment\n* Visit the clinic at 6 and 18 months for blood samples\n* Visit the clinic at the start of the study and after 1, 2, and 3 years for bone scans and blood samples.",[27],[98,99,36,33,100],"Alendronate","Discontinuation","post-menopausal","RECRUITING","2025-02-28",{"date":104,"type":42},"2025-03-07",{"date":106,"type":42},"2025-02-21",{"date":108,"type":21},"2029-09-15",{"name":110,"class":49},"Odense University Hospital",7,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":83},"100571445","phase-4-efficacy-of-romosozumab-and-denosumab-combined-treatment-in-postmenopausal-osteoporosis-patients-with-multiple-fragility-fractures-100571445","NCT06720350","Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures","MORD","Inclusion Criteria:\n\n* Postmenopausal Women\n* Patients with Osteoporosis\n* Patients aged between 55 and 85 years old\n\nExclusion Criteria:\n\n* Patient with history of Serebrovascular diseases\n* Patient with history of Miyocardial Infarction\n* Patients who have calcium metabiolism disturbances\n* Patients with chronic kidney diseases\n* Patient with history of allergic reactions to denosumab or romosozumab","85 Years",{"count":121,"type":21},60,[24],"The aim of this clinical trial is to investigate the effectiveness of romosozumab started without stopping denosumab in patients diagnosed with postmenopausal osteoporosis with a very high risk of fragility fractures and who is under at least 2 years of denosumab treatment. The main questions aimed to answer are:\n\n* Does it effective to prevent fractures add Romosozumab to ongoing denosumab treatment?\n* If it is appropiate to quit denosumab for starting 1 year romosozumab treatment?\n* If there is complications in denosumab and romosozumab combination treatment?\n\nResearchers will compare the Romosozumab 210mg subcutaneous(sc) monthly plus denosumab 60mg per 6 months sc treatment to prooceeding denosumab treatment and romosozumab 210mg monthly treatment in patient whom denosumab cessaced.\n\nParticipians are postmenopousal women with osteoporosis and they are under at least 2 years of treatment with denosumab and they will:\n\n* Add 210 mg monthly romosozumab sc injection or switch to 210 mg monthly romosozumab sc injection or proceed 60mg per 6 months denosumab sc injection\n* Visit the clinic at least once every 3 months and first month of new treatment regimen, blood tests per 3 months and Bone mineral density examination per 6 months\n* Keep a diary of their symptoms",[27],[36,126,30,31],"Combination Therapy","2024-12-25",{"date":129,"type":42},"2024-12-27",{"date":131,"type":21},"2025-01-15",{"date":133,"type":21},"2026-12-15",{"name":135,"class":49},"Marmara University"]