| January 7, 2008 |
| May 11, 2009 |
| January 2008 |
| September 2009 (final data collection date for primary outcome measure) |
| Accelerated fracture healing of low energy fragility fractures, as based on motion analysis measurement [ Time Frame: Measured at 0, 4, 8, 12, and 16 weeks ] [ Designated as safety issue: No ] |
| Accelerated fracture healing of low energy fragility fractures based on motion analysis measurement. [ Time Frame: 0, 4, 8, 12 & 16 weeks ] [ Designated as safety issue: No ] |
| Complete list of historical versions of study NCT00594906 on ClinicalTrials.gov Archive Site |
| Radiologic evidence of callus formation [ Time Frame: Measured at 0 and 16 weeks ] [ Designated as safety issue: No ] |
| Radiologic evidence of callus formation. [ Time Frame: 0 & 16 weeks ] [ Designated as safety issue: No ] |
| |
| Use of Teriparatide to Accelerate Fracture Healing |
| Use of Teriparatide to Accelerate Fracture Healing |
The purpose of this study is to compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing. |
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. |
| |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
| Pelvic Fracture |
- Drug: Teriparatide
- Drug: Placebo
|
- Active Comparator: 30 participants will receive teriparatide (Forteo) injection pens.
- Placebo Comparator: 30 participants will receive placebo injection pens.
|
| |
| |
| Recruiting |
| 60 |
| March 2010 |
| September 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 55 Years and older |
| No |
|
|
| United States |
| |
| NCT00594906 |
| J. Edward Puzas, PhD, University of Rochester |
| P50 AR054041, 12801 |
| University of Rochester |
| National Institutes of Health (NIH) |
| Principal Investigator: |
J.Edward Puzas, PhD |
University of Rochester |
|
|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| May 2009 |
