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临床试验/NCT02150850
NCT02150850招募中不适用

Quebec Registry for Atypical Femur Fractures

McGill University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Predictors associated with AFFs

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

Predictors associated with AFFs

时间窗: Baseline

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

次要结局

  • Differences in lower limb geometric parameters between cases and controls(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Suzanne Morin

Associate Professor

McGill University

研究点 (1)

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Quebec Registry for Atypical Femur Fractures | 临床试验