In Vivo Discrimination of Hip Fracture With Quantitative Computed Tomography
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- The primary objective is to evaluate the contribution of QCT-image analysis to the prediction of the osteoporotic PFF risk, as compared to the reference standard, namely, DXA.
研究概览
简要总结
Numerous geometric and bone mineral density (BMD) parameters can be derived from quantitative computed tomography (QCT) images of the proximal femur analyzed using dedicated software. The primary objective is to evaluate the contribution of QCT-image analysis to the prediction of the osteoporotic hip fracture risk, as compared to the reference standard, namely, dual energy X-ray absorptiometry (DXA).
Study hypothesis: For predicting osteoporotic hip fracture, findings from QCT images of the proximal femur analyzed using dedicated software are superior over DXA measurements of proximal femoral BMD.
详细描述
Background Osteoporotic hip fractures exact an immense human and economic toll and therefore constitute a major public health problem. Because their incidence increases exponentially with age in both men and women, they will impose an increasing burden in the near future as the population continues to age throughout the world. In addition to the direct costs of fractures (hospitalisation and rehabilitation), the subsequent risks of death, functional impairment, dependency, and institutionalization are increased as compared to same-age individuals without fractures. Low BMD is the main risk factor for hip fracture and is generally measured using DXA, which is the reference standard.
Objectives Our research project aims to identify QCT factors that predict osteoporotic hip fracture. To this end, we will use image analysis software specially designed for proximal femur evaluation to assess 3D QCT images of the proximal femur. Femoral BMD and geometry parameters will be studied. This method has been validated experimentally. Our working hypothesis is that it will prove superior over DXA (the reference standard) in predicting osteoporotic Phip fractures.
Originality
The QCT-image analysis method investigated in our study is original, as there are no commercially available tools for measuring proximal femur BMD on QCT images. This original method grew out of 6 years of work conducted jointly at the Medical Physics Institute of the Erlangen University and the Experimental Radiology Laboratory of the LARIBOISIERE-St-Louis Research and Training Unit. Advantages of our method include 3D evaluation of the hip (with measurement of the true volumetric density), evaluation of both BMD and bone geometry, and separate evaluations of cortical and trabecular bone. DXA produces 2D images of the hip, spine, or wrist that neither provide geometric data (except projected neck length) nor allow separate analysis of cortical and trabecular bone.
We will use a case-control design to investigate postmenopausal patients with hip fracture and female age-matched controls without hip fracture.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The primary objective is to evaluate the contribution of QCT-image analysis to the prediction of the osteoporotic PFF risk, as compared to the reference standard, namely, DXA.
时间窗: 1 month
次要结局
- To compare the value of BMD parameters and geometric parameters in predicting osteoporotic PFFs(1 month)
- To compare the roles for cortical bone and trabecular bone in predicting osteoporotic PFFs(1 month)
- To look for differences between cervical and trochanteric hip fractures(1 month)