Quebec Registry for Atypical Femur Fractures

Recruiting

• Conditions: Atypical Femur Fracture

• Registration Number: NCT02150850
• Lead Sponsor: McGill University

Brief Summary

Bisphosphonates are recommended as first-line agents to reduce fracture risk in patients with osteoporosis and have in general an excellent safety profile. However, recent reports have noted that prolonged use of bisphosphonates may be associated with rare but serious adverse effects, namely atypical femur fractures (AFF), an atraumatic subset of subtrochanteric and diaphyseal fractures.

The overarching aim of this project is to contribute to the characterization of clinical, biomechanical, radiological and genetic predictors of AFF, associated or not with bisphosphonate and-or denosumab therapy. AFF arise on the lateral (external) aspect of the subtrochanteric and diaphyseal regions of the femur, regions subjected to high mechanical loads. Because of this unique distribution, the investigators hypothesis is that patients with AFF demonstrate specific geometrical variations of their femur whereby baseline tensile forces applied to the lateral cortex are higher and might favour the appearance of these rare stress fractures. Measurements to investigate these geometric variations with be calculated from 3D images reconstructed using scans procured using the EOS® low irradiation 2D-3D X-Ray scanner.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• age 45 years and older
• men and women from Quebec who sustain (or have sustained) an AFF (complete or incomplete), as defined by the American Society of Bone and mineral Research (ASBMR) International Task Force on AFFs (Shane E et al J Bone Miner Res 2014;29:1-24)

Exclusion Criteria

• inability to consent
• disorders of bone metabolism other than osteoporosis
• active cancer
• life expectancy less than 12 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictors associated with AFFs	Baseline	Measured as the frequency of possible risk factors including demographic and clinical characteristics.

Secondary Outcome Measures

Name	Time	Method
Differences in lower limb geometric parameters between cases and controls	Baseline	Measured from 3D images reconstructed using scans procured using the EOS® low irradiation 2D-3D X-Ray scanner.

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada