Evaluation of Dual Energy X-ray Absorptiometry Scanners in the Identification of Atypical Femur Fractures - A Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- HD-IVA visualization of incomplete femur fractures
研究概览
简要总结
DXA scanners are routinely used to assess bone mineral density (BMD) and fracture risk in osteoporosis patients. They provide detailed bone imaging in a low radiation setting. Hologic manufactures scanners that are able to perform high definition instant vertebral fracture assessment (HD-IVA) used to screen at-risk patients for asymptomatic spine fractures instantly and reliably at the same time they are having their yearly BMD. We wish to investigate whether this same proven technology (HD-IVA scan mode) used on femurs (the scan mode is now called SE Femur scans) can be used to screen for atypical fractures of the femur in patients at risk for these debilitating fractures. In this proof of concept study, we propose to examine whether DXA scanners can provide a sensitive low radiation screening method to identify incomplete AFFs in patients with known incomplete AFFs and in patients at risk.
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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Known AFF group
- •A subject must have experienced an incomplete atypical low trauma fracture of the femoral shaft;
- •Is a patient at the UHN osteoporosis clinic.
- •Comparison Group
- •Must be scheduled for a bone mineral density scan at UHN
- •Have been on any bisphosphonate for 5 years or longer, and;
- •Have unexplained symptoms of leg, hip, thigh, or knee pain.
排除标准
- •There are no exclusions
结局指标
主要结局
HD-IVA visualization of incomplete femur fractures
时间窗: 1 day (one time point )
Hologic DXA scanner using the high-definition IVA (HD-IVA) mode on femur bones will be able to visualize incomplete femur fractures at least 90% of the time in patients with known incomplete AFF.
次要结局
未报告次要终点