Quebec Registry for Atypical Femur Fractures

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02150850

Enrollment

150

Registered

2014-05-30

Start date

2012-04-30

Completion date

2026-04-30

Last updated

2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atypical Femur Fracture

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Differences in lower limb geometric parameters between cases and controls	Baseline	Measured from 3D images reconstructed using scans procured using the EOS® low irradiation 2D-3D X-Ray scanner.

Other

Measure	Time frame	Description
Change from baseline in functional impairment	6- 12- 24- 36- months post fracture	Measured using the Lower Extremity Functional Scale (LEFS).
Change in global function status	6- 12- 24- 36- months post fracture	Measured using The Reintegration to Normal Living Index (RNLI).

Countries

Canada

Contacts

Primary ContactMichelle Wall, MSc.

michelle.wall@mail.mcgill.ca514-934-1934

Outcome results