Clinical trial NCT02150850: Quebec Registry for Atypical Femur Fractures
Official title: Quebec Registry for Atypical Femur Fractures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atypical Femur Fracture
Keywords: Femoral Fractures
Subtrochanteric Fractures
Osteoporotic Fractures
Fractures, Spontaneous
Stress Fractures
Bone Fractures
Hip Fractures
Osteoporosis
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-05-30
Enrollment: 150
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have sustained an AFF.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Predictors associated with AFFs
timeFrame: Baseline
Secondary outcomes:
measure: Differences in lower limb geometric parameters between cases and controls
timeFrame: Baseline
Other outcomes:
measure: Change from baseline in functional impairment
timeFrame: 6- 12- 24- 36- months post fracture
measure: Change in global function status
timeFrame: 6- 12- 24- 36- months post fracture
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Suzanne Morin, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: