Quebec Registry for Atypical Femur Fractures

NCT02150850 | Recruiting

• 1 other identifier: A00-M23-12A
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Atypical Femur Fracture

Keywords

Femoral Fractures; Subtrochanteric Fractures; Osteoporotic Fractures; Fractures, Spontaneous; Stress Fractures; Bone Fractures; Hip Fractures; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Predictors associated with AFFs

  Measured as the frequency of possible risk factors including demographic and clinical characteristics.

  Baseline

Secondary Outcomes (1)

• Differences in lower limb geometric parameters between cases and controls

  Baseline

Other Outcomes (2)

• Change from baseline in functional impairment

  6- 12- 24- 36- months post fracture

• Change in global function status

  6- 12- 24- 36- months post fracture

Study Arms (3)

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.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have sustained an AFF.

You may qualify if:

• 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)

You may not qualify if:

• inability to consent
• disorders of bone metabolism other than osteoporosis
• active cancer
• life expectancy less than 12 months.

Sponsors & Collaborators

• McGill University: lead
• Fonds de la Recherche en Santé du Québec: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Femoral Fractures; Hip Fractures; Osteoporotic Fractures; Fractures, Spontaneous; Fractures, Stress; Fractures, Bone; Osteoporosis

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries; Hip Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Suzanne Morin, MD MSc

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Wall, MSc.

CONTACT

514-934-1934; michelle.wall@mail.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 30, 2014
• Study Start: April 1, 2012
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)