protocolSection identificationModule nctId: NCT06303284, orgStudyIdInfo id: Pending, briefTitle: Post-surgical Outcomes With Anabolic Agent Use in High-risk Ankle Fractures: A Pilot RCT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, descriptionModule briefSummary: 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.There 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.The 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.This 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., conditionsModule conditions: Ankle Fractures, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: subcutaneous Teriparatide injection, interventions name: placebo, outcomesModule primaryOutcomes measure: Participant recruitment rate, secondaryOutcomes measure: Incidence of composite measure of complications, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: modified Radiological Union Scale for Tibia [RUST] score),, secondaryOutcomes measure: Olerud Molander Score, secondaryOutcomes measure: EuroQol five dimensions [EQ-5D], secondaryOutcomes measure: short form-12 [SF-12], secondaryOutcomes measure: pain visual analogue score [VAS], secondaryOutcomes measure: time-to-fracture union, secondaryOutcomes measure: 90 day mortality, secondaryOutcomes measure: Bone mineral density, secondaryOutcomes measure: Total cost and QALYs, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False