View Clinical Trial (Medical Research Study)
Use of Teriparatide to Accelerate Fracture Healing
| City: |
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Rochester |
| State: |
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New York |
| Zip Code: |
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14642 |
| Conditions: |
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Pelvic Fracture |
| Purpose: |
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The purpose of this study is to compare the effect of the drug teriparatide to the effect of
placebo on pelvic fracture healing.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00594906 |
| Primary Contact: |
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Principal Investigator
J.Edward Puzas, PhD
University of Rochester
Sarah Neu, BS
Phone: 585-341-9302
Email: sarah_neu@urmc.rochester.edu
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| Backup Contact: |
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Email: krista_noble@urmc.rochester.edu
Krista Noble, BS
Phone: 585-341-9303
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| Location Contact: |
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Rochester, New York 14642
United States
Nancy Hibsch, BS
Phone: 585-341-9304
Email: nancy_hibsch@urmc.rochester.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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