Hip Radiographs: Novel Method to Diagnose Osteoporosis

描述（由申请人提供）：这个小型企业创新研究第一阶段项目旨在开发骨质疏松症的诊断技术，并通过量化髋部x射线中的小梁结构元素来评估骨折风险。骨质疏松症是一个公共健康威胁，仅在美国就有4400万妇女。无法确定有患病风险的人是对付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。这是由于高成本和导致安装基础小的市售骨质疏松症检测系统。Imaging Therapeutics公司提议通过将现成的x射线设备与新型图像分析算法连接起来，开发低成本的骨骼结构分析技术。虽然骨密度（BMD）的测量很容易进行，并且有助于确定何时进行干预治疗，但骨密度低只占骨折风险的一部分。小梁结构的进行性破坏是剩余风险的主要原因。本提案的目的是：1)开发新的图像处理技术，用于髋部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x线摄影技术对骨结构x线摄影测量的影响。3)通过a)将尸体股骨近端核心的2d测量结果与使用3D微型CT进行的类似测量结果进行比较，以及b)确定它们是否与生物力学失效载荷和刚度显著相关，来确定这些体外2d测量结果的临床有效性。4)将本提案一期开发的技术直接应用于将为二期开发的一系列临床试验，以证明该技术在骨质疏松症诊断和骨质疏松性骨折预测方面的临床应用。

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.