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Post-surgical Outcomes With Anabolic Agent Use in High-risk Ankle Fractures: A Pilot RCT

NCT06303284 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-03-18

No results posted yet for this study

Summary

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.

Conditions

  • Ankle Fractures

Interventions

DRUG

subcutaneous Teriparatide injection

20 µg subcutaneous (SC) Teriparatide injection

OTHER

placebo

placebo 20 µg subcutaneous saline placebo injection once daily for 3 months in the post-operative ankle fracture population.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-12-31
Completion
2027-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06303284 on ClinicalTrials.gov