[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteoporosis-risk\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteoporosis-risk":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,50,81,105,139],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100607653","phase-2-resistance-training-and-rapamycin-to-enhance-bone-formation-in-postmenopausal-women-100607653",false,"NCT07191353","Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women","StrongBone","Inclusion Criteria:\n\n* Women aged 60-75 years old, any ethnicity.\n* Participants with T- score between \\\u003C 1.0 and \\> -2.5 measured by DXA scan within 6 months of the first day of the study.\n* Adequate cognitive function to be able to give informed consent.\n\nExclusion Criteria:\n\n* Osteoporosis and fracture history\n\n  * Participants with osteoporosis (defined by DXA scan \\\u003C 6 months old: low bone mass, T-score \\\u003C -2.5 or hip fracture or clinical compression fracture of the spine).\n  * History of low energy fractures within last 6 months. Health conditions limiting exercise\n  * Health conditions that could limit walking and weightbearing exercise (for instance recent surgery, mobility limitation)\n  * Participants with impaired wound healing or history of a chronic open wound Bone metabolism disorders\n  * Primary hyperparathyroidism.\n  * Known vitamin D deficiency (\\\u003C25 nM) (re-test after substitution acceptable).\n  * Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (eGFR \\\u003C 30) or impaired liver function (baseline phosphatase higher than twice upper limit (105 U\u002FL)), active rheumatic diseases, celiac disease, severe chronic obstructive lung disease (COPD), hypopituitarism, or Cushing's disease.\n  * Previous use of bone antiresorptive or bone anabolic drugs within the last 5 years.\n\nMedication use and health conditions\n\n* Use of anabolic steroids in the previous year.\n* Use of antiresorptive therapy in the previous year.\n* Known medication\u002Fsupplements affecting bone in the previous year.\n* Diabetes type 1 and 2.\n* Heart failure similar to NYHA Class IV.\n* Treatment with drugs known to affect cytochrome P450 3A due to its role in everolimus metabolism, excluding strong CYP3A4 inhibitors or inducers, while allowing weak and intermediate inhibitors or inducers. Patients on the following drugs will be excluded from the trial: Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Telithromycin, Clarithromycin, Nedazodone, Ritonavir, Atazanavir, Saquinavir, Darunavir, Indinavir, Nelfinavir, Rifampicin, Dexamethasone, Carbamazepine, phenobarbital, Phenytoin, Efavirenz and Nivirapine.\n* History of coagulopathy or medical condition requiring long-term anticoagulation.\n\nBlood disorders and other health concerns\n\n* Anemia - Hg \\\u003C 5,59 mmol\u002FL, Leukopenia - white blood cells (WBC) \\\u003C 3,5 x 10⁹\u002FL, Neutropenia absolute neutrophil count \\\u003C 2,0 x 10⁹\u002FL, or Platelet count - platelet count \\\u003C 125 x 10⁹\u002FL.\n* Insufficiently treated dyslipidemia with LDL-c \\> 4,9 mmol\u002FL and family history of dyslipidemia, Total cholesterol \\> 9,1 mmol\u002FL, or triglycerides \\> 9,9 mmol\u002FL.\n\nImmunosuppressive and current cancer Treatment\n\n* Scheduled for immunosuppressant therapy for transplant or scheduled to undergo chemotherapy or any other treatment for malignancy\n* Any form of clinically relevant primary or secondary immune dysfunction or deficiency Cardiovascular and heart conditions\n* Unstable ischemic heart disease.\n\nAllergies\n\n* Known allergy to rapamycin or rapalogs. Language limitations\n* The study will exclude participants with inability to speak and understand Danish and with inability to cooperate.",true,"FEMALE","60 Years","75 Years",{"count":21,"type":22},148,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The aim of the present clinical trial is to examine the effects of everolimus, resistance training, or their combination on bone and muscle health formation in elderly women aged 60-75 years. The main questions it aims to answer are:\n\nCan rapamycin's analog (Everolimus), resistance training, or their combination, enhance bone formation and muscle functions in elderly women compared to non-treatment controls.\n\nParticipants will be randomized 1:1:1:1 to one of the following treatment regimens:\n\n* Oral everolimus 5 mg once a week.\n* Oral placebo once a week.\n* Oral everolimus 5 mg once a week plus resistance training RT 1 hour, 3 times weekly.\n* Oral placebo once a week plus resistance training RT 1 hour, 3 times weekly.\n\nDuring the study there will be a total of 5-7 visits, where the participants will undergo the following:\n\n* Blood samles\n* DXA-, HRpQCT- (only Odense Universitetshospital) and MRI-scans\n* Muscle- and bone biopsies\n* Quality of life questionnaires\n* Testing of muscle funtion\n* Metabolic studies of muscle and bone protein turnover using labelling with deuturated water",[28,29,30],"Healthy","Osteopenia","Osteoporosis Risk",[32,33,34,35,36],"Postmenopausal Women","Rapamycin","Bone formation","Muscle functions","Healthy aging","RECRUITING","2026-03-31",{"date":40,"type":41},"2026-04-06","ACTUAL",{"date":43,"type":41},"2025-10-20",{"date":45,"type":22},"2027-03-01",{"name":47,"class":48},"Odense University Hospital","OTHER",2,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100557702","comparison-of-bone-microarchitecture-analysed-by-hrpqct-and-pqct-in-pathologies-with-bone-loss-andor-muscle-loss-100557702","NCT06541548","Comparison of Bone Microarchitecture Analysed by HRpQCT and pQCT in Pathologies With Bone Loss and\u002For Muscle Loss","Comparison of Bone Microarchitecture Analysed by High Resolution Peripheral Microscanner (HR-pQCT) and Peripheral Microscanner (pQCT) in Pathologies With Bone Loss and\u002For Muscle Loss","MICROS","Inclusion Criteria:\n\nFor the patients:\n\nWomen or men treated at the Saint-Etienne University Hospital and presenting an osteoporotic risk with one of the following associated pathologies:\n\n* Osteoporosis defined by: History of a documented brittle bone fracture\n* Bone fragility: Patient with indication for bone densitometry but no history of fracture\n* Inflammatory joint disease:\n\n  * Rheumatoid arthritis\n  * Spondyloarthritis\n* Chronic kidney disease\n* Endocrinopathies:\n\n  * Primary hyperparathyroidism\n  * Constitutional thinness\n  * Anorexia nervosa\n  * Obesity (BMI \\>30)\n  * Sarcopenia\n* Neuropathies - Parkinson's disease\n\nFor the controls:\n\nAcute episode of spinal or radiculalgia (less than one month old) with corticosteroid treatment of less than 1 month Signature of written consent\n\nExclusion Criteria:\n\n* No sign written consent\n\nFor the controls:\n\n* Medications inducing bone loss:\n* anti-aromasin or GnRH agonist for at least 6 months,\n* corticosteroids (dose ≥ 5 mg\u002Fd for 6 months)\n* anti-epileptic drugs: carbamazepine, phenobarbital, phenytoin, primidone, valproic acid for at least 6 months)\n* History of fracture due to bone fragility\n* Taking bone-targeting medication (biphosphonate, teriparatide, strontium ranelate)","ALL","18 Years",{"count":61,"type":22},1000,[63],"NA","The study aims to utilize medical devices, such as the Xtreme CT and XCT 3000, to assess bone and muscle microarchitecture for various pathologies. The devices provide crucial data on bone and muscle density, aiding in understanding fracture risks associated with conditions like rheumatoid arthritis and neurological disorders. Current methods like DXA scanning have limitations in predicting fracture risks accurately due to their inability to assess cortical and trabecular microstructure. The study emphasizes the importance of evaluating cortical porosity and trabecular volume loss, especially in conditions like post-menopausal osteoporosis and sarcopenia. Additionally, it explores the impact of neurological disorders, renal insufficiency, and endocrinopathies on bone health. Furthermore, the study aims to establish a control group to differentiate pathological changes from age-related variations. Expected outcomes include a comprehensive understanding of bone microarchitecture alterations across various pathologies and the potential to improve fracture risk estimation beyond conventional methods like DEXA scanning. Ultimately, the study anticipates facilitating better management strategies to reduce fracture risks associated with these conditions.",[30,66],"Bone Loss",[68,69,70],"Bone microarchitecture","Bone fragility","osteoporosis","2026-02-27",{"date":73,"type":41},"2026-03-03",{"date":75,"type":41},"2026-02-02",{"date":77,"type":22},"2035-05",{"name":79,"class":48},"Centre Hospitalier Universitaire de Saint Etienne",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":16,"sex":17,"minAge":88,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100595567","evaluation-of-osteo-buddy-in-improving-osteoporosis-knowledge-100595567","NCT07034131","Evaluation of Osteo-Buddy in Improving Osteoporosis Knowledge","Improving Both Health in Women With the Use of Osteo-Buddy to Enhance Osteoporosis Knowledge - A Mixed Method Clinical Trial","Inclusion Criteria:\n\n* Age 50 and above\n* Medium or high Osteoporosis Self-Assessment Tool for Asians (OSTA) score\n* Not undertaken Bone Mineral Density (BMD) scan\n* Never been treated with anti-osteoporosis medications such as bisphosphonates (e.g. alendronate, risendronate, ibandronate, zolendronate, pamidronate) or denosumab\n* Able to read and speak English\n* Currently use and own a smartphone where Osteo-Buddy can be used\n\nExclusion Criteria:\n\n* Known terminal illness\n* Visual, hearing and\u002For cognitive impairment or mental illness that renders them unable to provide informed consent","50 Years",{"count":90,"type":22},80,[63],"This is a pilot randomised controlled trial (RCT) to evaluate the use of a Virtual Health Assistant (VHA) named Osteo-Buddy in improving the knowledge of osteoporosis in older women.",[30,94],"Osteoporosis, Postmenopausal","NOT_YET_RECRUITING","2025-06-26",{"date":98,"type":41},"2025-07-01",{"date":100,"type":22},"2025-07",{"date":102,"type":22},"2026-03",{"name":104,"class":48},"SingHealth Polyclinics",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":125,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":80},"100571233","variation-in-drug-interactions-in-people-with-hiv-plwh-aged-60-years-and-older-100571233","NCT06717581","Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older.","Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older on Stable Antiretroviral Therapy Making a Switch to Bictegravir\u002FTenofovir Alafenamide\u002FEmtricitabine","Inclusion Criteria:\n\n* Age \\> 60 years\n* Non-infectious comorbidities receiving drug therapy\n* Receiving BIC\u002FTAF\u002FFTC therapy at the time of of enrollment\n\nExclusion Criteria:\n\n* Genotypic resistance testing that present or past evidence of viral resistance to the integrase inhibitor class, to emtricitabine or to tenofovir\n* Severe acute infectious disease",{"count":113,"type":22},50,"OBSERVATIONAL","Several cohort studies have recently shown a significant increase in the mean age of PLWH ( People Living With HIV) and in the prevalence of people in advanced age in the various cohorts, as a result of the marked increase in the mean life expectancy of these people achieved by modern antiretroviral combination therapies.\n\nHowever, the high prevalence of comorbidities exposes PLWH in old age to the need to take multiple drug treatments in addition to antiretroviral therapy, with the gradually increasing risk of unfavorable pharmacokinetic interactions between antiretroviral drugs and drugs taken to treat the comorbidities.\n\nThis project consists of an observational, cohort, retrospective, single-center study and aims to evaluate the variation in the number and type of clinically significant drug interactions between antiretroviral therapy and concomitant therapies in PLWH aged \\>60 years on stable antiretroviral therapy who, for any reason at the Clinician's discretion, have made a switch from ongoing antiretroviral therapy to the bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide regimen.",[117,118,119,120,121,122,123,30,124],"HIV Infections","Drug Interaction","Elderly Infection","Comorbidities and Coexisting Conditions","Cardiovascular Diseases","Metabolic Disease","Renal Disease","Neoplasms",[126,127,128,129],"HIV","Drug Interactions","Retrovirus","Comorbidities","2024-12-01",{"date":132,"type":41},"2024-12-05",{"date":134,"type":41},"2024-10-11",{"date":136,"type":22},"2025-10-11",{"name":138,"class":48},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":58,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":80},"100550534","fragility-re-fractures-prediction-score-100550534","NCT06448325","Fragility Re-fractures Prediction Score","RIFRA - Re-fracture Risk Prediction in Patients With Fragility Fracture: Score Development and Validation","RIFRA","Inclusion Criteria:\n\n* People who underwent total or partial hip replacement (ICD 9 CM 81.51, 81.52) in five years (2013-2017) at the hospital for a compound fracture of the hip (ICD 9 CM 820, 820.01-820.09).\n\nExclusion Criteria:\n\n* People undergoing the same intervention for other reasons (e.g. pathological fracture, ICD 9 CM 733.14).\n\nICD 9 CM stands for International Classification of Disease, 9th Revision, Clinical Modification.",{"count":148,"type":22},800,"Fragility fractures increase among elderly patients worldwide, representing a global burden in terms of disability and care expenditure.\n\nOsteoporosis is asymptomatic up to the moment in which a first fracture occurs, reason why it is often underdiagnosed. Even after that, further fractures do occurr, as osteoporosis is often untreated. Several programs have been introduced worldwide to prevent secondary fractures among the population at risk (e.g., International Osteoporosis Foundation's Capture the Fracture), and several risk factors are being investigated to generate a predictive score. However, accurate validation is needed to make these scores reliable.\n\nIn this retrospective observational study, we aim to validate a predictive score trained on a population of elderly patients with a cohort of patients who underwent hip fracture surgery in a high-volume orthopedic center in the Region of Lombardy.",[30],"2024-06-03",{"date":153,"type":41},"2024-06-07",{"date":155,"type":41},"2024-05-28",{"date":157,"type":22},"2025-02-28",{"name":159,"class":48},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"]