CTFU: Five-Year Computed Tomography Follow-Up Study of Vertebral Fracture Risk Using Opportunistic Screening for Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,799
- 试验地点
- 1
- 主要终点
- Incident vertebral fracture
研究概览
简要总结
This study evaluates whether opportunistic osteoporosis screening using routinely acquired computed tomography (CT) scans improves fracture risk prediction compared with guideline-recommended FRAX-based screening from age 50. In current practice, few high-risk individuals identified by FRAX actually receive confirmatory dual-energy X-ray absorptiometry (DXA), despite the growing health and economic burden of osteoporotic fractures. Volumetric bone mineral density (vBMD) and CT-based detection of vertebral fractures can be extracted from existing CT images obtained for other indications, offering a non-invasive way to capture key determinants of fracture and mortality risk, including low BMD, age, and prevalent fractures. The trial therefore compares the diagnostic performance of FRAX major osteoporotic fracture risk versus CT-derived vBMD and CT-identified vertebral fractures for predicting incident vertebral fractures in older adults.
详细描述
Primary objective: To assess the predictive performance of opportunistic volumetric bone mineral density (vBMD) from routine thoracoabdominal CT scans for incident vertebral fractures over 5 years or longer.
Secondary objectives:
- To compare the performance of vBMD to predict incident vertebral fractures with other predictors, including demographic and clinical risk factors, FRAX algorithm scores for 5-year risk of major osteoporotic fractures (MOF), prevalent vertebral fractures, and prevalent clinical fractures, as well as combinations of these predictors.
- To stratify the analyses based on age decades and sex.
- To compare the predictive performance between CT scans with and without administration of i.v. contrast medium.
- To compare the predictive performance of vBMD (using asynchronous calibration) with Hounsfield units
- To describe the prevalence and incidence (in fractures per person-years) of the study population
- Assessment of the impact of a preventive treatment of patients at high risk of fracture in terms of the number of avoided fractures (simulation study)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Baseline CT and 5 years follow-up CT including parts of the lumbar spine
排除标准
- •CT: No sagittal reformations or axial slices ≤3 mm
- •CT: No inclusion of at least T6 to L4
- •No BMI data available
结局指标
主要结局
Incident vertebral fracture
时间窗: From enrollment to minimum 5 years follow-up
CT based detection of vertebral fractures
次要结局
- Clinical fragility fractures(From enrollment to maximum 10 years follow-up (upon availability))
研究者
Maximilian Löffler
Radiology Specialist
Technical University of Munich