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NCT Number: NCT02150850

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.

Recruiting

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Predictors associated with AFFs

    Time frame: Baseline

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

Secondary outcomes

  1. Differences in lower limb geometric parameters between cases and controls

    Time frame: Baseline

    Measured from 3D images reconstructed using scans procured using the EOS® low irradiation 2D-3D X-Ray scanner.

Other outcomes

  1. Change from baseline in functional impairment

    Time frame: 6- 12- 24- 36- months post fracture

    Measured using the Lower Extremity Functional Scale (LEFS).

  2. Change in global function status

    Time frame: 6- 12- 24- 36- months post fracture

    Measured using The Reintegration to Normal Living Index (RNLI).

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Wall, MSc.

CONTACT

[email protected]

514-934-1934 ext. 45742

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2012
Primary completion
2026
Study completion
2026
First posted
May 30, 2014
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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