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临床试验/NCT04110795
NCT04110795进行中(未招募)不适用

Personalizing Osteoporosis Care: Clinical & Genetic Risk Factors for Atypical Femur Fractures

University Health Network, Toronto6 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2018年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,200
试验地点
6
主要终点
Associations between AFF and clinical Risk Factor

研究概览

简要总结

The overall objective of this project is to identify clinical and genetic risk factors for Atypical Femur Fractures (AFFs) in Anti-resorptive therapy (ART) users by conducting a case control study of 330 cases of AFFs and 660 controls without AFFs matched for age, sex, race and duration of ART.

详细描述

Antiresorptive therapy (ART) drugs are effective osteoporosis treatment and help decrease osteoporosis-related fractures. However, their long-term use has been associated with rare but serious atypical femur fractures (AFFs). Fear of these side effects has caused a substantial decline in the use of these effective drugs and rising fracture rates. The investigators propose to compare 330 cases of people with AFFs to 660 matched controls to explore similarities and differences in (1) clinical findings, such as type of ART and length of use, prior fracture, bone density, femur geometry, etc., and (2) genetic variants, and then (3) to validate the top few genetic variants to see if they are indeed present in an additional group of 100 AFF patients and not present in 100 control subjects. This study will determine clinical and genetic risk factors for these debilitating atypical fractures such that at-risk patients in the future can be treated differently to avoid them.

研究设计

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

入排标准

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

入选标准

  • Cases: Have experienced a confirmed, documented Atypical femur fracture
  • Controls: currently on anti-resorptive therapy, matches AFF case by age, race and length of ART use

排除标准

  • 未提供

结局指标

主要结局

Associations between AFF and clinical Risk Factor

时间窗: baseline

Associations between AFFs and clinical risk factors

Associations between AFF and common genetic variants

时间窗: baseline

Associations of common genetic variants among patients with AFFs

Validation of top genetic variants

时间窗: baseline

To validate the top few genetic variants identified in the above case-control study in a separate cohort of 100 cases and 100 controls.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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