[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658330":3},{"organization":4,"outcomesModule":7,"designInfo":69,"detailedDescription":70,"studyPopulation":73,"armGroups":70,"interventions":74,"overallOfficials":70,"centralContacts":82,"locations":91,"responsibleParty":109,"collaborators":111,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":70,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":70,"studyType":128,"phases":70,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":135,"whyStopped":70,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Universidade do Porto","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":56},[9],{"measure":10,"description":11,"timeFrame":12},"Prevalence of Osteoporosis","Weighted proportion of the population screened (individuals aged between 40 and 90 years) diagnosed with osteoporosis by Dual-Energy X-ray Absorptiometry (T-score ≤ -2.5).","Baseline",[14,17,21,25,28,32,35,38,41,44,47,50,53],{"measure":15,"description":16,"timeFrame":12},"Fracture Risk","Fracture risk assessment with the Portuguese-adapted FRAX®. Patients will be categorized in low fracture risk, moderate fracture risk and high fracture risk.",{"measure":18,"description":19,"timeFrame":20},"Prevalence of CKD-associated Osteoporosis","Proportion of individuals with CKD meeting osteoporosis diagnostic criteria","Baseline and 3 months",{"measure":22,"description":23,"timeFrame":24},"Creatinine","Serum levels of Creatinine (mg\u002FdL)","Baseline, 3 months and 12 months",{"measure":26,"description":27,"timeFrame":24},"eGFR","Estimated glomerular filtration rate (eGFR) calculated by the CKD-EPI equation.",{"measure":29,"description":30,"timeFrame":31},"Calcium","Serum levels of Calcium (mg\u002FdL)","Baseline and 12 months",{"measure":33,"description":34,"timeFrame":31},"Phosphate","Serum levels of phosphate (mg\u002FdL)",{"measure":36,"description":37,"timeFrame":31},"Alkaline phosphatase","Serum levels of Alkaline phosphatase (U\u002FL)",{"measure":39,"description":40,"timeFrame":31},"25-Hydroxyvitamin D","Serum levels of 25-Hydroxyvitamin D (ng\u002FmL)",{"measure":42,"description":43,"timeFrame":31},"Parathyroid Hormone","Serum levels of Parathyroid Hormone (pg\u002FmL)",{"measure":45,"description":46,"timeFrame":31},"P1NP","Serum levels of N-terminal propeptide of type 1 procollagen (P1NP) (ng\u002FmL)",{"measure":48,"description":49,"timeFrame":31},"CTX","Serum levels of C-terminal cross-linked telopeptide of type 1 collagen (CTX) (pf\u002FmL)",{"measure":51,"description":52,"timeFrame":31},"Health-related quality of life score (EQ-5D-5L)","Quality of life evaluated using the EQ-5D-5L questionnaire, assessing disease control trajectories and comparing individuals with osteoporosis, with and without CKD.",{"measure":54,"description":55,"timeFrame":31},"Medication adherence score (ERAM-7)","Adherence to pharmacological treatment evaluated using the scale \"Escala de AutoReporte de Adesão à Medicação\" (ERAM-7).",[57,60,63,66],{"measure":58,"description":59,"timeFrame":31},"Sclerostin","Serum levels of Sclerostin (pmol\u002FL)",{"measure":61,"description":62,"timeFrame":31},"RANKL","Serum levels of RANKL (Receptor Activator of NF-KB Ligand) (pg\u002FmL)",{"measure":64,"description":65,"timeFrame":31},"Osteoprotegerin","Serum levels of Osteoprotegerin (pg\u002FmL)",{"measure":67,"description":68,"timeFrame":31},"FGF23","Serum levels of FGF23 (Fibroblast Growth Factor-23) (RU\u002FmL)",{"allocation":70,"interventionModel":70,"interventionModelDescription":70,"primaryPurpose":70,"observationalModel":71,"timePerspective":72,"maskingInfo":70},null,"COHORT","PROSPECTIVE","The study population comprises adults aged 40 to 90 years registered at the Primary Healthcare Units of the ULS de Barcelos\u002FEsposende",[75,79],{"type":76,"name":77,"description":78,"armGroupLabels":70,"otherNames":70},"DIAGNOSTIC_TEST","Fracture risk assessment tool (FRAX)","A random sample stratified by age and gender distribution from the pre-screening USF list will undergo osteoporotic fracture risk assessment via a validated, Portugal-adapted FRAX® algorithm conducted via structured telephone interviews.",{"type":76,"name":80,"description":81,"armGroupLabels":70,"otherNames":70},"Dual-Energy X-ray Absorptiometry (DXA)","All participants with a moderate\u002Fhigh fracture risk for osteoporosis will undergo Bone Mineral Density assessment by DXA, as well as a subsample of low fracture risk patients.",[83,88],{"name":84,"role":85,"phone":86,"phoneExt":70,"email":87},"Janete Santos, PhD","CONTACT","+351 220 426 569","sjanete@med.up.pt",{"name":89,"role":85,"phone":70,"phoneExt":70,"email":90},"Carlos Vaz, MD, PhD","carlosvaz@med.up.pt",[92],{"facility":93,"status":70,"city":94,"state":70,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"ULS de Barcelos\u002FEsposende","Barcelos","4750-333","Portugal","PT",{"type":99,"coordinates":100},"Point",[101,102],-8.61843,41.53174,{"lat":102,"lon":101},[105],{"name":106,"role":85,"phone":107,"phoneExt":70,"email":108},"Juliana Magalhães, MD","+351 253 809 200","jcmagalhaes@ulsbe.min-saude.pt",{"type":110,"investigatorFullName":70,"investigatorTitle":70,"investigatorAffiliation":70,"oldNameTitle":70,"oldOrganization":70},"SPONSOR",[112],{"name":113,"class":114},"ULS Barcelos\u002FEsposende","UNKNOWN","100658330","osteoporosis--renal-disease-research-in-primary-health-care-services-100658330",false,"NCT07848490","Osteoporosis & Renal Disease: Research in Primary Health Care Services","Osteoporosis & Renal Disease: Research in Primary Health Care Services - A Pilot Study","Inclusion Criteria:\n\n* Age between 40 years and 90 years;\n* Registered at participating Primary Healthcare Unit;\n* Capable of providing informed consent.\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C12 months;\n* Severe cognitive\u002Fphysical impairment;\n* Inability to undergo DXA.","ALL","40 Years","90 Years",{"count":126,"type":127},622,"ESTIMATED","OBSERVATIONAL","Osteoporosis, a silent and multifactorial systemic skeletal disorder, severely compromises bone strength and significantly increases the risk of fragility fractures. Despite its high prevalence (affecting \\~10% of Portuguese over 50), it remains critically underdiagnosed and undertreated, with over 80% of fragility fractures occurring in untreated individuals.\n\nChronic Kidney Disease (CKD) profoundly exacerbates bone fragility, giving rise to CKD-associated osteoporosis, a complex skeletal disorder often integrated within CKD-Mineral and Bone Disorder. This systemic dysregulation of mineral metabolism not only impairs bone quality but also actively promotes vascular calcification and significantly elevates cardiovascular disease risk, underscoring a critical kidney-bone-vascular nexus. Despite these well-established links, CKD-associated osteoporosis is similarly underdiagnosed and undertreated, partly due to diagnostic challenges related to Bone Mineral Density interpretation and therapeutic hesitancy in this complex patient population.\n\nThis multi-phase observational study is designed to address the significant public health challenges posed by osteoporosis and by osteoporosis associated with CKD in Portugal, particularly among individuals aged 40 years to 90 years. The study aims to enhance understanding of disease prevalence, identify diagnostic and treatment gaps, and evaluate management trajectories, while emphasizing the intricate interrelationships among bone health, renal function, and cardiovascular risk.",[131,132],"Osteoporosis","Chronic Kidney Disease Mineral and Bone Disorder",[131,134,132],"Chronic Kidney Disease","NOT_YET_RECRUITING","2026-09-23",{"date":138,"type":139},"2026-09-30","ACTUAL",{"date":141,"type":127},"2026-10-01",{"date":143,"type":127},"2027-12-31",{"name":5,"class":6},1]