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

University Of Rochester, Rochester NY

Investigators

Linked publications & trials

Abstract

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