The Effect of Long-term Use of Bisphosphonates on Femur Morphology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- femoral lateral bowing
研究概览
简要总结
Recent studies have shown that bone modeling can occur throughout life, suggesting bone has a persistent ability of adapting structure to loading. Some bone medications have a significant effect on the process of bone modeling based on histological studies. Bisphosphonates (BP), a classical anti-resorption drug which impacts the process of bone turnover, is related with atypical femur fractures while the mechanism is unclear. Several hypotheses are considered competitive. Among them, increased femur bowing is associated with atypical femoral fractures. However, it remains doubtful whether long-term BP use increases femur bowing. Thus, the investigators design this retrospective cohort study.
详细描述
If the participants meet the Inclusion Criteria, the investigators will collect the baseline characteristics of patients including age, gender, body mass index (BMI), as well as characteristics of BMD by dual-energy X-ray absorptiometry (DXA), BP treatment (type of drugs, duration before baseline). The primary outcome was femoral lateral bowing (FLB), femoral neck shaft angle (FNSA), and hip knee shaft angle (HKSA) from the frontal plane in standing radiographs of the lower limbs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •standing radiographs of the lower limb
排除标准
- •non-standard lower limbs X-ray , rheumatoid arthritis, tumor of the femur， congenital anomalies of the lower extremity
研究组 & 干预措施
patients with over 5-year BP history
patients who took bisphosphonates over 5 years
干预措施: Bisphosphonates (Drug)
control patients without BP usage
patients who do not receive bisphosphonates therapy
干预措施: Control (Other)
结局指标
主要结局
femoral lateral bowing
时间窗: through study completion, an average of 8 years
Angle between axes of 20% proximal and distal sections of femur diaphysis
次要结局
- femoral neck shaft angle (FNSA)(through study completion, an average of 8 year)
- hip knee shaft angle(through study completion, an average of 8 years)