Quebec Registry for Atypical Femur Fractures

StatusActive, Not Recruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Apr 2026 → Apr 2028
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Record History

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  1. Notable Primary and study completion pushed from Apr 2026 to Apr 2028 Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 6 words
    • Site details revised
    • Collaborators: details revised at 1 of 3 entries
  2. Minor Re-verified, no change to tracked fieldsv7
  3. Notable Primary and study completion dates: Apr 2022 to Apr 2026v6
  4. Minor 4 versions Re-verified since Dec 6, 2016, no change to tracked fieldsv2-v5
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT02150850
Lead Sponsor McGill University
Collaborators: Fonds de la Recherche en Santé du Québec, McGill University Health Centre/Research Institute of the McGill University Health Centre, Canadian Institutes of Health Research (CIHR)
Conditions
(from sponsor)
Atypical Femur Fracture
Related terms Femoral Fractures, Fractures, Bone, Fractures, Spontaneous, Fractures, Stress, Hip Fractures, Osteoporosis, Osteoporotic Fractures
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov