[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539395":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":31,"locations":30,"responsibleParty":41,"collaborators":30,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":30,"eligibilityCriteria":48,"healthyVolunteers":45,"sex":49,"minAge":50,"maxAge":30,"enrollmentInfo":51,"targetDuration":30,"studyType":54,"phases":55,"briefSummary":58,"conditions":59,"keywords":30,"overallStatus":61,"whyStopped":30,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":30},{"fullName":5,"class":6},"University of Calgary","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Teriparatide","EXPERIMENTAL","20 µg subcutaneous Teriparatide injection once daily for 3 months in the post-operative ankle fracture population.",[13],"Drug: subcutaneous Teriparatide injection",{"label":15,"type":16,"description":17,"interventionNames":18},"placebo","SHAM_COMPARATOR","20 µg subcutaneous saline placebo injection once daily for 3 months in the post-operative ankle fracture population.",[19],"Other: placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","subcutaneous Teriparatide injection","20 µg subcutaneous (SC) Teriparatide injection",[9],[9],{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"placebo 20 µg subcutaneous saline placebo injection once daily for 3 months in the post-operative ankle fracture population.",[15],null,[32,37],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"Prism S Schneider","CONTACT","403-944-4518","prism.schneider@gmail.com",{"name":38,"role":34,"phone":39,"phoneExt":30,"email":40},"Jessica Duong","403-220-3366","jduong@ucalgary.ca",{"type":42,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100539395","phase-1-post-surgical-outcomes-with-anabolic-agent-use-in-high-risk-ankle-fractures-a-pilot-rct-100539395",false,"NCT06303284","Post-surgical Outcomes With Anabolic Agent Use in High-risk Ankle Fractures: A Pilot RCT","Inclusion Criteria:\n\n* Our study will include men and women over 60 years of age presenting to the emergency department with low energy ankle fractures (fall from standing height) requiring surgical treatment and who have one or more of the following risk factors, diabetes, osteoporosis, renal disease, steroid use, smoking history, peripheral neuropathy and\u002For vascular disease.\n\nExclusion Criteria:\n\n* Individuals will be excluded if they have received previous Teriparatide therapy, or they have hypercalcemia or hyperparathyroidism, as these are precautions to the use of Teriparatide.","ALL","60 Years",{"count":52,"type":53},80,"ESTIMATED","INTERVENTIONAL",[56,57],"PHASE1","PHASE2","As the global population ages and the prevalence of poor bone health increases among older patients with ankle fractures, so does the risk of post-surgical complications. Prevention of post-surgical complications is of paramount importance to reducing morbidity, mortality, and healthcare costs.\n\nThere is growing evidence to support the use of bone-building medications, such as Teriparatide, in patients who have delayed fracture healing or non-unions; however, these medications have yet to be investigated in elderly patients with ankle fractures at high risk for delayed fracture healing and post-operative complications. This project aims to assess the safety and efficacy of short-term Teriparatide use in improving outcomes in a population most likely to suffer post-operative complications.\n\nThe proposed study is a pilot randomized controlled trial (RCT) with patients 60 years or older with an additional risk factor for delayed healing (i.e., osteoporosis, diabetes, vascular disease) who require ankle fracture surgery. Participants will be randomized to receive the study medication (Teriparatide) or placebo for three months. The primary objective of this study is to acquire vital data (i.e., recruitment rates, follow-up rates, adherence to treatment assignment) required to determine the feasibility of a full-scale multi-centre RCT. Additional aims are to evaluate repeat surgery, complications, time-to-union, and 90-day mortality. A complete a socio-economic and feasibility analysis will be completed.\n\nThis study will evaluate the novel clinical approach of augmenting surgical fixation with a medication to build bone density and strength, thereby improving bone health, preventing complications, and improving outcomes. This study will also inform planning for a larger clinical trial to reduce the morbidity, mortality, and cost associated with complications in this high-risk population.",[60],"Ankle Fractures","NOT_YET_RECRUITING","2024-03-15",{"date":64,"type":65},"2024-03-18","ACTUAL",{"date":67,"type":53},"2025-01-01",{"date":69,"type":53},"2027-06-01",{"name":5,"class":6}]