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| Name | Class |
|---|---|
| Fonds de la Recherche en Santé du Québec | OTHER_GOV |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Registry | Patients who have who have sustained an AFF that consent to participating in the registry only. | ||
| Cases | Patients who have sustained an AFF that consent to participating in the registry and undergoing EOS® imaging. | ||
| Controls | For each case we will identify one age- (± 5 years), sex-, height- (± 6 cm) and cumulative bisphosphonate or denosumab exposure ( ±2 years) matched control who has not sustained an AFF to undergo EOS® imaging. |
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| Measure | Description | Time Frame |
|---|---|---|
| Predictors associated with AFFs | Measured as the frequency of possible risk factors including demographic and clinical characteristics. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in lower limb geometric parameters between cases and controls | Measured from 3D images reconstructed using scans procured using the EOS® low irradiation 2D-3D X-Ray scanner. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in functional impairment | Measured using the Lower Extremity Functional Scale (LEFS). | 6- 12- 24- 36- months post fracture |
| Change in global function status | Measured using The Reintegration to Normal Living Index (RNLI). |
Inclusion Criteria:
Exclusion Criteria:
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Patients who have sustained an AFF.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle Wall, MSc. | Contact | 514-934-1934 | 45742 | michelle.wall@mail.mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Suzanne Morin, MD MSc | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal General Hospital | Recruiting | Montreal | Quebec | H3G 1A4 | Canada |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D006620 | Hip Fractures |
| D058866 | Osteoporotic Fractures |
| D005598 | Fractures, Spontaneous |
| D015775 | Fractures, Stress |
| D050723 | Fractures, Bone |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D025981 | Hip Injuries |
| D001851 | Bone Diseases, Metabolic |
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AFF patients only will be asked to deposit 2 ml of saliva into a collection tube using a standardized protocol. Individuals unable to produce 2ml of saliva will be asked to perform at least two buccal swabs.
| 6- 12- 24- 36- months post fracture |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |