Hip Radiographs: Novel Method to Diagnose Osteoporosis

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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.