[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fragility-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fragility-fracture":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,47,80,103,135,158,186,212,234,266,288,314],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100638293","feasibility-study-of-a-digital-interactive-life-style-platform-for-individuals-after-rehabilitation-100638293",false,"NCT07597031","Feasibility Study of a Digital Interactive Life-style Platform for Individuals After Rehabilitation","Feas Platf","Inclusion Criteria:\n\n* Adults (≥18 years)\n* 10 or less days before discharge from inpatient rehabilitation at the Bern Rehab Center in Heiligenschwendi or the Insel Hospital (both belonging to the Insel Group)\n* Belonging to one of the following clinical cohorts: acute coronary syndrome or ischemic heart failure; chronic obstructive pulmonary disease (COPD) - clinically diagnosed and confirmed by pulmonary specialist; fragility fracture - e.g., hip fracture or other low-energy fractures; minor stroke, clinically confirmed ischemic or hemorrhagic stroke with mild neurological deficits.\n* Able to provide informed consent.\n* Access to and ability to use a device that has internet access (e.g., tablet, smartphone, laptop, etc.).\n\nExclusion Criteria:\n\n* Cognitive or psychiatric condition interfering with consent or use of the app.\n* Physical disability preventing digital device use without support.\n* Heavy language production or comprehension impairments.","ALL","18 Years",{"count":19,"type":20},240,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to evaluate the feasibility and usability of a digital lifestyle platform designed to support patients after discharge from inpatient rehabilitation. It will also assess patient engagement and the potential of the platform to support long-term self-management and healthy lifestyle behaviors in an outpatient setting.\n\nThe main questions it aims to answer are:\n\nIs the platform feasible and acceptable for patients after rehabilitation? Do patients engage with and regularly use the platform over time? Can personalized digital recommendations support adherence to healthy behaviors and self-management?\n\nResearchers will evaluate a telemedicine platform that delivers individualized suggestions, including lifestyle applications, educational content, and advice from healthcare professionals. The content is tailored to patient needs and continuously adapted based on patient feedback.\n\nParticipants will:\n\nUse the digital platform after discharge from inpatient rehabilitation for a defined follow-up period Receive personalized recommendations through the platform Rate the usefulness of recommendations to enable continuous adaptation Attend study visits or remote assessments to evaluate usability, engagement, and outcomes Continue standard outpatient care alongside the intervention",[26,27,28,29],"Chronic Obstructive Pulmonary Disease (COPD)","Acute Coronary Syndrome","Fragility Fracture","Minor Stroke",[31,32,33],"Telemedicine","Phase III rehabilitation","Long-term non-communicable diseases","RECRUITING","2026-05-18",{"date":37,"type":38},"2026-05-19","ACTUAL",{"date":40,"type":20},"2026-05-01",{"date":42,"type":20},"2027-02-01",{"name":44,"class":45},"Matthias Wilhelm, MD","OTHER",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100423628","restore---study-of-agn1-loep-to-prevent-secondary-hip-fractures-100423628","NCT04796350","RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures","Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP) to Prevent Secondary Hip Fractures in Osteoporotic Women Undergoing Treatment of Index Hip Fractures","Inclusion Criteria:\n\n1. Subject is a postmenopausal female at least 1-year post menses and at least 65 years of age and less than 92 years of age.\n2. Subject presents with a low-energy index fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.\n3. Subject has at least one of the following additional risk factors for a secondary hip fracture (as determined by subject or legally authorized representative (LAR) interview or medical record review):\n\n   * Documented falls assessment indicating subject is at moderate or high risk of falls\n   * Falls history (2 or more falls in the previous 12 months)\n   * History of vertigo, dizziness, or postural hypotension\n   * Documented T-score \\\u003C -2.5 at the hip\n   * Taking more than 3 daily prescription medications\n   * Visual impairment as confirmed by one of the following:\n\n     * Subject reports difficulty seeing\n     * Lack of depth perception or vision loss in one eye\n     * Macular degeneration\n     * Cataracts\n   * Prior non-hip fragility fracture\n   * Cognitive frailty as assessed by SPMSQ (mild cognitive impairment determined by SPMSQ ≤ to 4) or delirium\n   * Parkinson's disease stage 3 or 4\n   * 10-year hip fracture probability \\>15% using the FRAX® Fracture Risk Assessment Tool of the clinical site country\n4. Subject is expected to be ambulatory after the hip fracture repair procedure. \"Ambulatory\" is defined as a patient's ability to ambulate beyond simple transfers with or without assistive devices.\n5. Informed consent is provided by the subject or the subject's LAR. Use of an LAR to obtain patient consent requires that the patient must understand and be able to participate in post operative restrictions and requirements.\n6. The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full duration of the study has been documented.\n\nExclusion Criteria:\n\n1. Criterion omitted\n2. Criterion omitted\n3. Subject is currently enrolled in another interventional clinical study affecting the target hip.\n4. Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the index hip fracture.\n5. Subject has new fractures in addition to the index hip fracture at admission that, in the opinion of the investigator, would further compromise patient mobility, rehabilitation, or recovery.\n6. Subject has an infection at the LOEP intended treatment site or has non-intact skin or acute traumatic injuries with open wounds close to the area of intended LOEP treatment.\n7. Subject has a progressive increase in undiagnosed pain in the target hip contralateral to the index fractured hip over the previous 3 months that in the opinion of the Investigator may suggest underlying bone or joint pathology on the unfractured side.\n8. Subject has radiological evidence of gross bony or joint pathology of the hip, including signs predictive of atypical femoral fractures (e.g. cortical beaking), or has been diagnosed and\u002For treated for atypical femoral fractures.\n9. Criterion omitted\n10. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).\n11. Criterion omitted\n12. Subject has active cancer\n13. Criterion omitted\n14. Criterion omitted\n15. Criterion omitted\n16. Criterion omitted\n17. Criterion omitted\n18. Subject has end stage renal insufficiency defined as an estimated glomerular filtration rate (eGFR) \\\u003C 15 mL\u002Fmin.\n19. Criterion omitted\n20. Criterion omitted\n21. Subject has moderate or severe cognitive impairment as assessed by an SPMSQ of 5 or higher.\n22. Subject has known allergies to calcium-based bone void fillers.\n23. In the judgement of the Investigator, the subject is not a good study candidate (e.g., poor mental health, or active drug or alcohol abuse issues), and or subject would not be a good candidate to undergo an ELECTIVE orthopedic surgical procedure such as a total hip arthroplasty in her current medical, physiological condition.\n24. Subject fails pre-operative or intraoperative eligibility criteria as specified in section 7.4.2. of the clinical investigation plan.","FEMALE","65 Years","91 Years",{"count":58,"type":20},2400,[23],"A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures. Up to 2400 subjects will be randomized between a treatment group and a control group. Subjects will be followed for a minimum of 5 years after undergoing hip fracture repair surgery.",[28,62,63],"Hip Fractures","Osteoporosis",[63,65,28,66,67,68],"Hip Fracture","LOEP","RESTORE","Local osteo-enhancement procedure","2026-05-11",{"date":71,"type":38},"2026-05-13",{"date":73,"type":38},"2021-04-24",{"date":75,"type":20},"2029-04-01",{"name":77,"class":78},"AgNovos Healthcare, LLC","INDUSTRY",66,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":67,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100551053","restore-reducing-future-fractures-and-improving-outcomes-of-fragility-fracture-100551053","NCT06455085","RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE","Inclusion Criteria:\n\n* Age 50 years and older (no upper age limit)\n* Sustained a primary fragility fracture (hip\u002Ffemur, pelvis, clinical spine, humerus, wrist) in the last 12 months\n* Participant must self-identify a regular primary care provider (PCP)\n* Participant must provide a mailing address\n* Participant must plan to remain geographically proximate (able to travel if necessary) to the site from which they are recruited over the next several months\n\nExclusion Criteria:\n\n* Exposure to the following medications in the prior 12 months;\n* Actonel or Atelvia (risedronate)\n* Fosamax or Binosto (alendronate)\n* Reclast, Zometa, or Aclasta (zoledronic acid, zoledronate)\n* Boniva or Bondronat (ibandronate)\n* Aredia (pamidronate)\n* Prolia (denosumab)\n* Evenity (romozosumab)\n* Tymlos (abaloparatide)\n* Forteo (teriparatide)\n* Natpara (parathyroid hormone)\n* Evista (raloxifene)\n* Duavee (bazedoxifene-conjugated estrogen)\n* Miacalcin (calcitonin)\n* Diagnosis of the following medical conditions;\n* CKD stage 4 or 5 or on dialysis\n* Multiple myeloma\n* Addison's disease\n* Adrenal insufficiency\n* Enrolled hospice care\n* Solid organ transplant, or expecting a solid organ transplant\n* Bone marrow transplant\n* History of metabolic bone disease (except osteoporosis) such as Paget's disease, osteomalacia, osteogenesis imperfecta, or Cushing's disease\n* Fractures resulting from severe trauma (e.g. motor vehicle accidents, a fall from 2 feet or higher elevation)\n* Pathologic fractures secondary to malignancy or infection\n* Scheduled appointment with a bone health specialist\n* Participant unable to consent on their own (cognitive impairment, dementia, etc.)\n* Currently enrolled in another research study that requires taking medication","50 Years",{"count":88,"type":20},2634,[23],"RESTORE tests whether Augmented-FLS, where patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health provider, is better than Enhanced Usual Care, which includes patient and PCP education and activation. We also aim to determine the influence of age, race, ethnicity, sex, poverty level, geographic region, and timing of entry into the trial after a fracture on the effectiveness of the two strategies.",[63,92,28],"Osteoporotic Fractures","2026-04-29",{"date":95,"type":38},"2026-05-05",{"date":97,"type":38},"2024-12-16",{"date":99,"type":20},"2029-06-01",{"name":101,"class":45},"University of Alabama at Birmingham",23,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":110,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":121,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100633731","real-world-evidence-of-si-bones-ifuse-torq-tnt-advancing-treatment-of-pelvic-ring-fractures-100633731","NCT07530497","Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures","REBAR","Inclusion Criteria:\n\n1. ≥ 60 years of age at screening\n2. Pelvic pain correlating with fracture location that began EITHER within 6 weeks of a known low-energy traumatic event, OR pelvic insufficiency fracture with pain that is limiting mobility\n3. Diagnostic imaging (X-ray and CT) showing fracture of the pelvis that correlates with pain location\n4. Patient is scheduled for pelvic fixation using at least one iFuse TORQ TNT\n5. Patient and\u002For patient's legally authorized representative (LAR) understands and is willing and able to provide written informed consent\n6. Patient agrees to comply with study schedule of assessments\n7. Patient and\u002For patient's proxy can complete study-related surveys\n8. Patient was able to ambulate prior to index fracture\n\nExclusion Criteria:\n\n1. Any known anatomic issues that could prevent placement of iFuse TORQ TNT\n2. Implants already in the pelvis (e.g. lumbopelvic fixation) that could interfere with placement of the study device(s)\n3. Patient requires lumbosacral pelvic fixation as part of index procedure\n4. Prominent neurologic or uncontrolled psychiatric condition that would interfere with study participation or regaining of physical function related to pelvic fracture and is unable to provide a health care proxy to complete study assessments.\n5. Estimated lifespan \\\u003C 12 months\n6. Presence of tumor, lytic lesion, infection, or soft tissues that precludes safe internal fixation\n7. Not candidate for surgery due to underlying medical illness\n8. Social situation that makes 12-month follow-up unlikely\n9. History of recent (within 1 year) non-index pelvic fracture with non-union\n10. Other clinically active fragility fracture of spine, hip or arms\u002Flegs that could impair recovery from sacral fracture\n11. Known allergy to titanium or titanium alloys\n12. Known or suspected active drug or alcohol abuse, including opioids\n13. Patient is a prisoner or ward of the state\n14. Patient is already participating in an investigational clinical trial that may interfere with implant placement or study follow-up","60 Years",{"count":112,"type":20},120,"OBSERVATIONAL","The purpose of this study is to evaluate outcomes in patients treated with iFuse TORQ TNT for pelvic fragility fractures.",[116,117,28,118,119,120],"Fracture; Pelvic","Insufficiency Fractures","Sacroiliac; Fusion","Sacroiliac Joint Disruption","Sacroiliac Joint Dysfunction",[28,122,123,124],"pelvic fracture","Osteoporotic pelvic fracture","Fragility Fracture of the pelvis","NOT_YET_RECRUITING","2026-04-15",{"date":128,"type":38},"2026-04-20",{"date":130,"type":20},"2026-08",{"date":132,"type":20},"2028-08",{"name":134,"class":78},"SI-BONE, Inc.",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":46},"100519985","phase-2-essential-amino-acid-supplementation-for-femoral-fragility-fractures-100519985","NCT06050668","Essential Amino Acid Supplementation for Femoral Fragility Fractures","MEND Repair & Recover Clinical Trial","Inclusion Criteria:\n\n* Hospital inpatient\n* Age ≥ 65 years old on admission\n* Low-energy mechanism of injury\n* Diagnosis of femur fracture (OTA 31, 32, or 33 fracture)\n* Indicated for surgical fixation\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Part of a vulnerable population (ex: Incarcerated, Non-English speaking)\n* Cognitive impairment (MMSE score ≤ 17)\n* Electrical medical implant (ex: Pacemaker\u002FDefibrillator, Left Ventricular Assist Device, Cochlear implant, Insulin pump, Pain medication pumps, Spinal cord stimulator)\n* Non-ambulatory prior to injury\n* Inability to consume an oral diet or allergy to supplement ingredients (ex: milk allergy)\n* Concern for inability to complete follow-up\n* Hemi or total arthroplasty (joint replacement)\n* Patients with a historical diagnosis of chronic kidney disease (CKD)",{"count":143,"type":20},60,[145],"PHASE2","This trial will evaluate the impact of 4 weeks of postoperative essential amino acid (EAA)-based supplementation on muscle morphology after femoral fragility fracture. This trial will assess the ability of EAA-based to increase skeletal muscle metabolic activity, reduce inflammation, and induce muscle fiber hypertrophy, as well as preserve skeletal muscle mass and physical performance up to 6 months after injury. Participants will be randomized in a 1:1 ratio to 1) standard of care (no dietary intervention) or 2) EAA-based supplementation.",[148,28,149],"Femoral Fracture","Muscle Atrophy","2026-04-14",{"date":126,"type":38},{"date":153,"type":38},"2024-06-17",{"date":155,"type":20},"2026-12",{"name":157,"class":45},"Michael C Willey",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100504712","phase-4-serotonin-norepinephrine-reuptake-inhibitor-in-prophylaxis-of-depression-following-fragility-fractures-100504712","NCT05851898","Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Fractures","The Role of SNRI's in the Prophylaxis of Depression in the First Year Following Lower Extremity Fragility Fractures in Geriatric Patients","SNRI","Inclusion Criteria:\n\n* Geriatric (greater than or equal to 65 years old)\n* Lower extremity fragility fractures managed operatively\n\nExclusion Criteria:\n\n* Polytrauma\n* Pathological fractures\n* Patients on hospice\n* Patients with previously diagnosed psychiatric disorders\n* Patients with previously diagnosed dementia\n* Patients already taking Selective serotonin reuptake inhibitors (SSRI)s and Serotonin- norepinephrine reuptake inhibitors (SNRI)s\n* Patients already taking mood stabilizing medication\n* Unable to provide informed consent (no use of a legal authorized representative)\n* Patients with pre-existing life limiting diagnoses (cancer, etc.)",{"count":167,"type":20},100,[169],"PHASE4","The goal of this pilot study is to learn about the feasibility about prescribing anti-depressants at discharge in patients aged 50 years and older with a lower extremity fragility fracture. The main questions it aims to answer are:\n\n* What are the obstacles to enrolling patients and prescribing anti-depressants among older adults?\n* Is it possible to start prescribing SNRI medication upon discharge?\n* What is the prevalence of depressive symptoms amongst patients with different types of injuries and weightbearing status?\n* What is a transition of care plan for patients who have geriatric depression and require further care?\n\nParticipants will:\n\n* Undergo screening using the Geriatric Depression Scale\n* Start on Duloxetine 30mg daily at time of discharge\n* Report medication compliance and complete re-screening monthly\n* Complete patient reported outcome measures and 3 months, 6 months, and 1 year\n* Receive a referral to behavioral health, primary care, or psychiatrist for evaluation if they screen positive at any timepoint",[172,28],"Depression in Old Age",[174,175],"Geriatrics","Serotonin-norepinephrine","2026-03-11",{"date":178,"type":38},"2026-03-12",{"date":180,"type":38},"2024-04-08",{"date":182,"type":20},"2028-12",{"name":184,"class":45},"Wake Forest University Health Sciences",1,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":185},"100422964","image-guided-computational-and-experimental-analyses-of-fractured-patients-bone-gap-100422964","NCT04787679","Image-guided Computational and Experimental Analyses of Fractured Patient's Bone (GAP)","GAP","Inclusion Criteria:\n\n* Age: \\>=18 years\n* primary hip replacement\n* Signature of informed consent\n* Patients who have a routine preoperative CT scan\n\nExclusion criteria:\n\n* Patients unrelated to the inclusion criteria of this study\n* Bone disease (non-osteoporotic) such as to invalidate sample analysis, including but not limited to genetic disorders and bone tumors\n* Patients with contralateral hip replacement and\u002For other synthetic means in the contralateral hip\n* Patients with synthesis devices in the hip of interest",{"count":194,"type":20},52,"Due to the increase in the average age of the population, the projections on the number of age-dependent bone fractures appear to be constantly increasing.\n\nThey are mainly due to bone pathologies, including osteoporosis. The latter leads to a reduction in bone mineral density and deterioration of the micro-architecture, with a consequent increase in bone fragility. However, the mechanisms of damage at the micro-scale have not yet been elucidated and there is no universally recognized damage criterion. Recent research has evaluated the importance of implementing computational models to study the influence of bone gaps, canaliculi and microporosities on the propagation of damage. These models need to be validated through experimental tests, still lacking, in particular on human bones, in the current scientific landscape. Once the experimental validation of computational models has been developed, it will be possible to introduce new fracture indices at the micro-scale, useful for a preventive diagnosis of osteoporosis.",[63,28],[198,199,200,201,202],"lacunae","damage models","micro-cracks","synchrotron","numerical models","2026-01-27",{"date":205,"type":38},"2026-01-29",{"date":207,"type":38},"2020-11-09",{"date":209,"type":20},"2028-08-09",{"name":211,"class":45},"Laura Maria Vergani",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":110,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":185},"100619639","mynourish-hydrolysed-collagen-supplementation-in-older-adults-with-fragility-fractures-100619639","NCT07347236","MyNOURISH: Hydrolysed Collagen Supplementation in Older Adults With Fragility Fractures","MyNOURISH: Effectiveness of Hydrolysed Collagen on Nutritional, Functional, Body Composition and Bone Health Among Older Adults With Fragility Fractures in Hospital Sultan Abdul Aziz. .","MyNOURISH","Inclusion Criteria:\n\n* Male or female participants aged 60 years and above.\n* History of a fragility fracture (e.g., hip, wrist, or vertebral fracture) sustained within the past 12 months.\n* Registered outpatient at Hospital Sultan Abdul Aziz Shah (HSAAS).\n* Malaysian citizen.\n* Able to communicate in Bahasa Malaysia or English.\n* Able and willing to provide written informed consent.\n* Cognitive function score \\>4 on the Elderly Cognitive Assessment Questionnaire (ECAQ).\n* Currently undergoing a structured rehabilitation programme.\n* May be receiving antiresorptive osteoporosis therapy or not receiving any osteoporosis pharmacological treatment at the time of recruitment.\n\nExclusion Criteria:\n\n* Cognitive impairment, defined as ECAQ score ≤4\n* Metabolic bone diseases other than osteoporosis (e.g., Paget's disease, osteomalacia).\n* Severe endocrine or metabolic disorders affecting bone metabolism (e.g., primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, hypogonadism, acromegaly).\n* Terminal illness or palliative care needs (e.g., advanced cancer, end-stage organ failure, late-stage neurodegenerative diseases).\n* Known allergy to fish, seafood, or collagen supplements, or diagnosis of phenylketonuria.\n* Kidney disease, including history of kidney stones or chronic kidney disease stage 4-5 (estimated glomerular filtration rate \\\u003C44 mL\u002Fmin\u002F1.73 m²).\n* Participation in another interventional study that may interfere with the study protocol.\n* Use of nutritional supplements during the study period.\n* Prior use of collagen or amino acid-based supplements within the past 6 months.\n* Non-ambulatory status prior to the fracture.\n* Unstable medical conditions (e.g., uncontrolled arrhythmias, recent myocardial infarction, unstable angina, uncontrolled hypertension, pulmonary embolism).\n* Current use of anabolic osteoporosis therapy.\n* Alcohol dependence or active alcoholism.",{"count":221,"type":20},76,[23],"The goal of this clinical trial is to learn whether hydrolysed collagen supplementation (PROTÉGEN Plus) within multidisciplinary care can improve nutrition and recovery in older adults with fragility fractures.\n\nThe main questions this study aims to answer are:\n\n1. Does collagen supplementation improve malnutrition status, nutritional biomarker (albumin levels), body composition (skeletal muscle and fat-free mass), functional capacity and bone turnover (P1NP and CTX) over 12 weeks intervention period?\n2. Does hydrolysed collagen supplementation have additional effects on the malnutrition status and functional capacity among older adult outpatients with fragility fractures at Week 6?\n3. Are the effects of hydrolysed collagen supplementation on the malnutrition status, nutritional biomarker (albumin), body composition (skeletal muscle and fat-free mass), functional capacity, and bone turnover biomarkers (P1NP and CTX) sustained up to 24 weeks post-intervention compared to standard care?\n\nResearchers will compare two groups of older adults (aged 60 years and above) receiving care at Hospital Sultan Abdul Aziz Shah (HSAAS), Universiti Putra Malaysia:\n\n\\- Intervention group: Participants will receive hydrolysed collagen (PROTÉGEN Plus) with usual care within a multidisciplinary team for 12 weeks.\n\nAttend study visits at baseline, week 6, week 12, and week 24 (for follow-up of sustained effects). Keep a diary to record supplement intake, adherence, and any side effects, and return unopened supplement sachets at week 6 and 12 to monitor compliance.\n\n\\- Control group: Participants will receive usual care within a multidisciplinary team. Attend study visits at baseline, week 6, week 12, and week 24 (for follow-up of sustained effects).\n\nThis study will help researchers understand whether adding tilapia-derived collagen supplementation to multidisciplinary care can support better nutrition, muscle and bone health, and long-term recovery in older adults after a fragility fracture. It is hoped that the findings will strengthen the evidence for incorporating targeted nutritional strategies as part of fragility fracture management and secondary fracture prevention.",[28],"2026-01-08",{"date":227,"type":38},"2026-01-16",{"date":229,"type":20},"2026-01",{"date":231,"type":20},"2027-06",{"name":233,"class":45},"Hospital Pengajar Universiti Putra Malaysia",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":110,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":244,"briefSummary":245,"conditions":246,"keywords":250,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":265},"100554267","early-internal-fixation-versus-nonoperative-care-with-early-rehabilitation-for-lc1-fragility-fractures-of-the-pelvis-100554267","NCT06496867","Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis","Multicenter Randomized Controlled Trial Comparing Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis: A Pilot Study","PIVOT-LC1-Pi","Inclusion Criteria:\n\n1. Patient 60 years of age or older.\n2. Low energy injury mechanism defined as a fall from standing height.\n3. LC1 pelvis fracture (AO\u002FOTA 61B1.1 or 61B2.1) confirmed with antero-posterior, inlet, and outlet pelvis radiographs, computed tomography, or magnetic resonance imaging.\n4. Fracture pattern that could be, in the judgment of the attending surgeon, managed with either early internal fixation or nonoperative care with early rehabilitation.\n5. Fracture displacement of \\\u003C10 mm of the posterior pelvic ring on computed tomography of the pelvis.\n6. Injury occurred within 21 days of screening.\n\nExclusion Criteria:\n\n1. Patient did not ambulate prior to injury.\n2. Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.\n3. Retained implants around the pelvis that precludes or limits either study treatment.\n4. Infection around the hip (soft tissue or bone).\n5. Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation.\n6. Patient is too ill, in the judgement of the attending surgeon, for internal fixation.\n7. Patient is too ill, in the judgement of the attending surgeon, for nonoperative care.\n8. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.\n9. Expected injury survival of less than 12 months.\n10. Terminal illness with expected survival of less than 12 months.\n11. Currently enrolled in a study that does not permit co-enrollment.\n12. Prior enrollment in the trial.\n13. Unable to obtain informed consent due to language barriers.\n14. Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.\n15. Did not provide informed consent (declined participation).\n16. Patient or LAR not approached to participate in the trial (missed patient).\n17. Other reason to exclude the patient, as approved by the Methods Centre.",{"count":243,"type":20},48,[23],"The goal of this randomized pilot study is to assess feasibility of the trial and to collect information to inform the design of a definitive trial. Adult patients ages 60 years or older with a low-energy lateral compression type 1 (LC1) pelvis fracture with \\\u003C10 mm initial displacement of the posterior pelvic ring will be eligible to participate in the study. Patients will be randomized to one of two treatment groups, early internal fixation or nonoperative care with early rehabilitation, defined as at least five days of attempted mobilization by rehabilitation providers. Participants will be followed for 1 year.",[247,28,248,249],"Multiple Closed Pelvic Fractures With Disruption of Pelvic Ring","Internal Fixation","Nonoperative Care",[28,251,252,253,248,249,254,255],"Lateral Compression type 1","Pelvis Fracture","Older Adults","Physical Therapy","Early","2025-10-10",{"date":258,"type":38},"2025-10-15",{"date":260,"type":38},"2024-11-12",{"date":262,"type":20},"2027-12-31",{"name":264,"class":45},"University of Southern California",13,{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":273,"sex":16,"minAge":86,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":21,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":185},"100504187","surgeon-initiated-bone-health-referral-pathway-in-patients-undergoing-lower-extremity-arthroplasty-100504187","NCT05845021","Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty","The Impact of a Surgeon-Initiated Bone Health Referral Pathway on Implant-Related Complications in Patients With Osteoporosis Undergoing Lower Extremity Arthroplasty","Inclusion Criteria:\n\n* \\>50\n* DEXA-confirmed diagnosis of osteoporosis\n\nExclusion Criteria:\n\n* Prior diagnosis of osteoporosis\n* Prior treatment for osteoporosis",true,{"count":275,"type":20},2000,[23],"The goal of this clinical trial is to observe the impact of a surgeon-driven bone health referral pathway following lower extremity arthroplasty. The main question this study aims to answer is:\n\n1\\) What is impact of a surgeon-driven bone health referral pathway on implant-related complications and fragility fractures when compared to standard of care primary care provider referral.\n\nResearchers will compare the endocrinology referral pathway and standard of care to see if there is a difference in treatment rates, fragility fractures, and implant-related complications following lower extremity arthroplasty.",[63,279,28],"Arthroplasty Complications",{"date":281,"type":38},"2025-10-14",{"date":283,"type":38},"2023-09-27",{"date":285,"type":20},"2028-07",{"name":287,"class":45},"Johns Hopkins University",{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":21,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":313},"100520253","impact-of-a-clinical-pathway-for-pelvic-fragility-fractures-100520253","NCT06054165","Impact of a Clinical Pathway for Pelvic Fragility Fractures","Impact of Regional Implementation of a Clinical Pathway for ELderly Patients With pelVIc Fragility fraCtures (PELVIC); a Multicenter, Stepped-wedge Randomized Controlled Trial","PELVIC","Inclusion Criteria:\n\n* Pelvic fragility fracture caused by low energetic trauma\n* Patients presented at the emergency room or out-patient clinic of a participating hospital\n\nExclusion Criteria:\n\n* Patients with high suspicion of a pelvic fracture due to a malignant tumor\n* Patients who are unable to follow instructions due to severe cognitive decline (for example due to dementia or Alzheimer's disease)\n* Patients who pre-trauma received palliative or terminal care\n* Patients who pre-trauma were wheelchair bound or bedridden\n* Patients who suffer from complications from previous pelvic ring fixation\n* Patients with insufficient comprehension of the Dutch language to be able to carry out the physiotherapy instructions for early mobilization",{"count":297,"type":20},393,[23],"Patients with pelvic fragility fractures suffer from high morbidity and mortality rates. Despite the high incidence of these injuries, there is currently no regional or nationwide treatment protocol which results in a wide variety of clinical practice. New insights in treatment strategies, such as early diagnosis and minimal invasive operative treatment of these fragile patient population, has led to the development of several clinical pathways in recent literature. The aim of this study is to implement an evidence and experience-based treatment clinical pathway to improve the outcomes in this fragile patient population that currently has multifactorial risks for poor outcome.",[301,302,303,28],"Pelvic Bone Injury","Sacral Fracture","Pelvic Fracture","2024-06-21",{"date":306,"type":38},"2024-06-24",{"date":308,"type":38},"2024-01-21",{"date":310,"type":20},"2027-04-27",{"name":312,"class":45},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",8,{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":21,"phases":324,"briefSummary":325,"conditions":326,"keywords":327,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":336,"locationsCount":338},"100526451","prevention-of-osteoporotic-fracture-2-pilot-study-100526451","NCT06134908","PRevention of OsTEoporotiC FracTure 2 Pilot Study","The Application of \"Precise Education + Shared Decision-Making\" Program for the Secondary Prevention of Fragility Fractures Based on Behavioral Theories: A Pilot Cluster Randomized Controlled Trial","PROTECT-2","Inclusion Criteria:\n\n1. Local residents (live in the city where the hospital is located for half a year or more);\n2. Hospitalized patients with fractures aged 50 years and above;\n3. First fracture, without history of fracture;\n4. Never diagnosed as \"osteoporosis\" before admission;\n5. No fracture history, and never receive any bone mineral density test, and never take anti-osteoporosis medication in the 4 years before admission;\n6. Hospitalized patients with the following fractures: hip fracture, thoracic spine fracture, and lumbar spine fracture;\n7. New fragility fracture: fracture that occurs after minor trauma or daily activities, such as a fracture caused by a fall from standing height or less; fracture happened within 6 weeks;\n8. Not living in a nursing or rehabilitation institution before fracture;\n9. Possess reading ability, and can read and understand informed consent forms or medical materials independently.\n\nExclusion Criteria:\n\n1. Patients with pathological fractures caused by tumor or infection;\n2. Patients with cognitive dysfunction or mental disorder;\n3. AIDS patients;\n4. Patients who refuse to follow-up, or have poor compliance for follow-up, or fail to understand and cooperate for follow-up;\n5. Hearing or visual impairment, and unable to communicate or read materials;\n6. Patients who have participate in other studies;\n7. Other conditions that the investigator considered inappropriate to enroll.",{"count":323,"type":20},50,[23],"With the aging of the world population, osteoporosis and fragility fractures have become global public health concerns. It has been estimated the population of people ≥60 years of age will increase from 229 million (16.2%) in 2017 to 479 million (35.1%) by 2050 in China. Because age is an important predictor of osteoporosis and fragility fracture, the incidence of fragility fracture has increased dramatically in China over the past decades. Timely treatment of osteoporosis is an effective way to decrease additional fracture risk among patients with fragility fractures, but anti-osteoporosis treatment rate is relatively low in China. Effective fracture prevention intervention is urgently needed in China.\n\nAs a potential way to achieve effective risk communication, shared decision-making allows patients to be active participants in the management of osteoporosis. The investigators designed a multifaceted intervention, which was named as \"Precise Education + Shared Decision-Making\" program for the secondary prevention of fragility fractures based on behavioral theories, and assessed the effectiveness for fracture prevention using a pilot cluster randomized controlled trial among several hospitals in China.\n\nThe aim of this pilot study is to test the acceptability and feasibility as well as preliminary efficacy of this program in patients with fragility fractures.",[28],[63,28,328,329],"Shared Decision-Making","Education","2024-05-23",{"date":332,"type":38},"2024-05-28",{"date":334,"type":38},"2024-01-13",{"date":231,"type":20},{"name":337,"class":45},"Third Affiliated Hospital, Sun Yat-Sen University",7]