Hip Radiographs: Novel Method to Diagnose Osteoporosis

描述（由申请人提供）：该小型企业创新研究I期项目旨在开发用于诊断骨质疏松症和通过量化髋关节X射线中的骨小梁结构元素来评估骨折风险的技术。仅在美国，骨质疏松症就威胁着4400万妇女的公共健康。无法查明可能感染该疾病的人是防治这一流行病的一个主要障碍。事实上，只有不到30%的骨质疏松症患者意识到自己患有骨质疏松症，这是由于商业上可获得的骨质疏松症测试系统的成本高，安装基数小。Imaging Therapeutics Inc提出通过将容易获得的X射线设备与新颖的图像分析算法相连接来开发用于低成本骨结构分析的技术。虽然骨矿物质密度（BMD）的测量很容易执行，并有助于确定何时进行治疗干预，但低BMD仅占骨折风险的一部分。骨小梁结构的进行性破坏是该风险的大部分剩余部分。本研究的目的是：1）开发新的图像处理技术，用于髋关节X线片中二维骨小梁结构元素的自动测量。2)确定X射线束角度、软组织衰减和放射技术对骨结构放射学测量的影响。3)通过a）在尸体股骨近端的核心中将这些2D测量值与使用3D微型CT进行的类似测量值进行比较和B）确定它们是否与生物力学失效载荷和刚度显著相关，来确定这些2D测量值的体外临床有效性。4)将本提案第一阶段开发的技术直接应用于第二阶段开发的一系列临床试验，以证明该技术在诊断骨质疏松症和预测骨质疏松性骨折方面的临床实用性。

DESCRIPTION (provided by applicant): This Small Business Innovation Research Phase I project is designed to develop techniques for the diagnosis of osteoporosis and for assessing fracture risk by quantifying trabecular structural elements in hip x-rays. Osteoporosis is a public health threat for 44 million women in the United States alone. The inability to identify persons at risk for the disease is a major impediment in dealing with this epidemic. In fact, less than 30% of persons with osteoporosis are aware that they have it. This is due to the high cost and resulting small installed base of commercially available osteoporosis testing systems. Imaging Therapeutics Inc. proposes to develop technology for low-cost bone structural analyses by linking readily available x-ray equipment to novel image analysis algorithms. While measurements of bone mineral density (BMD) are easy to perform and are helpful in determining when to intervene therapeutically, low BMD accounts for only a portion of fracture risk. Progressive disruption of trabecular structure contributes the better part of the remainder of that risk. The aims of this proposal are: 1) To develop new image processing techniques for automated measurement of 2D-trabecular bone structural elements in hip radiographs. 2) To determine the influence of x-ray beam angulation, soft-tissue attenuation and radiographic technique on radiographic measurements of bone structure. 3) To determine the clinical validity of those 2 D measurements in vitro by a) comparing them, in cores of cadaver proximal femora, to similar measurements made using 3D micro CT and b) determining if they correlate significantly with biomechanical failure loads and stiffness. 4) To directly apply the technology developed in Phase I of this proposal to a series of clinical trials that will be developed for Phase II to prove the clinical utility of that technology in the diagnosis of osteoporosis and prediction of osteoporotic fracture.