Rochester, New York 14642


Purpose:

The purpose of this study is to compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing.


Study summary:

Teriparatide is a man-made form of a naturally occurring hormone called parathyroid. It increases bone density and bone strength to help prevent fractures and can be used to treat osteoporosis in people who have a high risk of bone fracture. The purpose of this study is to compare the effect of teriparatide to the effect of placebo on pelvic fracture healing. This study will last 16 weeks. Participants will be randomly assigned to receive either teriparatide or placebo for the duration of the study. Participants will also be given calcium and vitamin D supplements to take daily throughout the study. At 4-week intervals, participants will undergo functional evaluations that will include the instrumented sit-to-stand test, the timed-up-and-go, and a gait velocity test. Participants will also undergo a DXA scan upon enrollment; undergo a CT evaluation upon enrollment and 16 weeks post-fracture; and complete specific pain, self-perceived function, mental status, and depression scales throughout the study.


Criteria:

Inclusion Criteria: - Females must be menopausal (no menses within the last 12 months) - Low energy fragility fractures of the pelvis, including anterior column, posterior column, inferior or superior rami, or sacrum - Maximum of 2 weeks post fracture - Mental status consistent with completing the study protocol Exclusion Criteria: - Currently receiving any treatment for osteoporosis, including estrogen and estrogenic-like compounds - Received radiation treatment to any site at any time in the past - Received chemotherapy for cancer at any time in the past - Any active cancer - Surgical repair (or attempted repair) of the fracture site in the pelvis - Use of any bone-active medications - Use of anticonvulsant therapy - Use of immunosuppressants - Any renal, gastrointestinal, liver, or metabolic bone disease - Pregnancy - High calcium, parathyroid hormone, or alkaline phosphatase, as based on laboratory results


NCT ID:

NCT00594906


Primary Contact:

Principal Investigator
J.Edward Puzas, PhD
University of Rochester

Sarah Neu, BS
Phone: 585-341-9302
Email: sarah_neu@urmc.rochester.edu


Backup Contact:

Email: krista_noble@urmc.rochester.edu
Krista Noble, BS
Phone: 585-341-9303


Location Contact:

Rochester, New York 14642
United States

Nancy Hibsch, BS
Phone: 585-341-9304
Email: nancy_hibsch@urmc.rochester.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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