P3: Role of PTH in enhancing fracture repair in aging (Clinical Trial)

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This project will investigate the effects of teriparatide (an analog of parathyroid hormone) on accelerating the fracture healing process in humans. Teriparatide is currently marketed under the brand name Forteo and is FDA approved for the treatment of osteoporosis. Our hypothesis is that teriparatide, by virtue of its ability to stimulate recruitment of chondrogenic and osteogenic cells, will accelerate the fracture healing process. The fracture site to be measured will be the pelvis. This will include all fractures of the anterior and posterior columns, superior and inferior rami and the sacrum. Subjects will be over the age of 55 and the fracture will have been due to a low energy trauma. Evaluation of fracture healing will be by functional tests as well as radiographic measurements of callus volume, evaluation of pain and self-perceived function. The study is designed to be a prospective, doubleblind, placebo controlled trial. It will be analyzed with an intent-to-treat analysis. In Aim 1 we will use an instrumented sit-to-stand test, a timed-up-and-go test and gait velocity to measure subject function during healing. We will also administer a self-assessment of function questionnaire to document the subjects impression of the healing. In Aim 2 we will quantify callus volume and monitor changes in pain levels, mental status and depression. At the conclusion of this trial we will be able to determine if teriparatide has any effect on the functional, biological or subject well-being aspects of healing a pelvic fracture.