Quebec Registry for Atypical Femur Fractures

Atypical Femur Fracture Clinical Trial

Official title:

Quebec Registry for Atypical Femur Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02150850
• Other study ID #: A00-M23-12A
• Status: Recruiting
• Start date: April 2012
• Est. completion date: April 2026

Study information

• Verified date: October 2023
• Source: McGill University
• Contact: Michelle Wall, MSc.
• Phone: 514-934-1934
• Email: michelle.wall[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atypical Femur Fracture
• Femoral Fractures
• Fractures, Bone

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
McGill University	Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in functional impairment	Measured using the Lower Extremity Functional Scale (LEFS).	6- 12- 24- 36- months post fracture
Other	Change in global function status	Measured using The Reintegration to Normal Living Index (RNLI).	6- 12- 24- 36- months post fracture
Primary	Predictors associated with AFFs	Measured as the frequency of possible risk factors including demographic and clinical characteristics.	Baseline
Secondary	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