Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Femoral fracture event
研究概览
简要总结
The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study.
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
- 65 Years 至 85 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •caucasic post-menopausal women resident in Emilia-Romagna
- •menopause (>= 45 years)
排除标准
- •not free living
- •Chronic diseases with severe organ failure / endocrine diseases of parathyroid, thyroid, adrenal gland / intestinal malabsorption, osteomalacia / Paget bone / rheumatoid arthritis. Neurodegenerative diseases
- •Long-term continuous therapy (>3 months) with corticosteroids and proton pump inhibitors or aromatase inhibitors
- •Previous femur fractures
- •Presence of hip/knee prosthesis
- •only for the fracturegroup:
- •presence of fixation devices after the fracture
- •femur fracture due to high energy trauma
结局指标
主要结局
Femoral fracture event
时间窗: 5 years
BBCT-hip risk prediction
时间窗: 5 years
次要结局
- T-score(5 years)