- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02150850
Quebec Registry for Atypical Femur Fractures
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Michelle Wall, MSc.
- Phone Number: 45742 514-934-1934
- Email: michelle.wall@mail.mcgill.ca
Study Locations
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Quebec
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Montreal, Quebec, Canada, H3G 1A4
- Recruiting
- Montreal General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age 45 years and older
- men and women from Quebec who sustain (or have sustained) an AFF (complete or incomplete), as defined by the American Society of Bone and mineral Research (ASBMR) International Task Force on AFFs (Shane E et al J Bone Miner Res 2014;29:1-24)
Exclusion Criteria:
- inability to consent
- disorders of bone metabolism other than osteoporosis
- active cancer
- life expectancy less than 12 months.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Registry
Patients who have who have sustained an AFF that consent to participating in the registry only.
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Cases
Patients who have sustained an AFF that consent to participating in the registry and undergoing EOS® imaging.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predictors associated with AFFs
Time Frame: Baseline
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Measured as the frequency of possible risk factors including demographic and clinical characteristics.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in lower limb geometric parameters between cases and controls
Time Frame: Baseline
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Measured from 3D images reconstructed using scans procured using the EOS® low irradiation 2D-3D X-Ray scanner.
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Baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in functional impairment
Time Frame: 6- 12- 24- 36- months post fracture
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Measured using the Lower Extremity Functional Scale (LEFS).
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6- 12- 24- 36- months post fracture
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Change in global function status
Time Frame: 6- 12- 24- 36- months post fracture
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Measured using The Reintegration to Normal Living Index (RNLI).
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6- 12- 24- 36- months post fracture
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Suzanne Morin, MD MSc, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A00-M23-12A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atypical Femur Fracture
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Ilocos Training and Regional Medical CenterUnknownIntertrochanteric Fractures | Pertrochanteric Fracture | Pertrochanteric Fracture of Femur, Closed | Pertrochanteric Fracture of Femur, Open
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Amr Gamaleldin Mahmoud Khalil GendyaCompletedGeriatrics | Distal Femur FractureEgypt
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University of Alabama at BirminghamCompletedSupracondylar Femur FractureUnited States