This project will investigate the effects of teriparatide (an analog of parathyroid hormone) on acceleratingthe fracture healing process in humans. Teriparatide is currently marketed under the brand name Forteoand is FDA approved for the treatment of osteoporosis.Our hypothesis is that teriparatide, by virtue of its ability to stimulate recruitment of chondrogenic andosteogenic cells, will accelerate the fracture healing process. The fracture site to be measured will be thepelvis. This will include all fractures of the anterior and posterior columns, superior and inferior rami and thesacrum. 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 callusvolume, 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 tomeasure subject function during healing. We will also administer a self-assessment of functionquestionnaire to document the subjects impression of the healing.
In Aim 2 we will quantify callus volumeand 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.
Showing the most recent 10 out of 133 publications
