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Quebec Registry for Atypical Femur Fractures

NCT02150850 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-11-20

No results posted yet for this study

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.

Conditions

  • Atypical Femur Fracture

Sponsors & Collaborators

  • Fonds de la Recherche en Santé du Québec

    collaborator OTHER_GOV

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • McGill University

    lead OTHER

Principal Investigators

  • Suzanne Morin, MD MSc · McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Canada

Study Locations

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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 NCT02150850 on ClinicalTrials.gov