Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Location status: Recruiting
NCT Number: NCT02150850
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.
Interested in participating?
Request Info45 year and older
All sexes
Observational
Montreal, Quebec, H3G 1A4, Canada
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Measured as the frequency of possible risk factors including demographic and clinical characteristics.
Time frame: Baseline
Measured from 3D images reconstructed using scans procured using the EOS® low irradiation 2D-3D X-Ray scanner.
Time frame: 6- 12- 24- 36- months post fracture
Measured using the Lower Extremity Functional Scale (LEFS).
Time frame: 6- 12- 24- 36- months post fracture
Measured using The Reintegration to Normal Living Index (RNLI).
Contact information is provided by the study sponsor or research team.
McGill University
Other
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