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