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: Recruiting
• Conditions: Atypical Femur Fracture

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Michelle Wall, MSc.; Phone Number: 45742 514-934-1934; Email: michelle.wall@mail.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Recruiting
      • Montreal General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have sustained an AFF.

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?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors associated with AFFs	Measured as the frequency of possible risk factors including demographic and clinical characteristics.	Baseline

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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).	6- 12- 24- 36- months post fracture

Collaborators and Investigators

• Sponsor: McGill University
• Collaborators: Canadian Institutes of Health Research (CIHR); McGill University Health Centre/Research Institute of the McGill University Health Centre; Fonds de la Recherche en Santé du Québec
• 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: April 1, 2012
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: May 20, 2014
• First Submitted That Met QC Criteria: May 27, 2014
• First Posted (Estimated): May 30, 2014

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Osteoporosis; Femoral Fractures; Hip Fractures; Osteoporotic Fractures; Subtrochanteric Fractures; Fractures, Spontaneous; Stress Fractures; Bone Fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: A00-M23-12A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO