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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02150850
Study type Observational [Patient Registry]
Source McGill University
Contact Michelle Wall, MSc.
Phone 514-934-1934
Email michelle.wall@mail.mcgill.ca
Status Recruiting
Phase
Start date April 2012
Completion date April 2026

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04110795 - Personalizing Osteoporosis Care: Clinical & Genetic Risk Factors for AFFs
Recruiting NCT01747291 - Atypical Fracture Cohort Study
Recruiting NCT01747304 - Evaluation of IVA (SE Femur Scans) to Identify Incomplete AFFs
Completed NCT01875458 - Biomarker Identification in Orthopaedic & Oral Maxillofacial Surgery Subjects to Identify Risks of Bisphosphonate Use