Recruiting

Observational Study

Sponsor:

McGill University

Code:

NCT02150850

Conditions

Atypical Femur Fracture

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT02150850

Start date

Apr, 2012

Status verified date

Nov, 2024

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Predictors associated with AFFs [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Locations

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G 1A4

More Information

Sponsor

McGill University

Last update posted

Nov 20, 2024

Last verified

Nov, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2024-11-20.