Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2008-01-31
2012-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Injection
30 participants will receive teriparatide (Forteo) injection pens.
Teriparatide
Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
Placebo
30 participants will receive placebo injection pens.
Placebo
Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
Interventions
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Teriparatide
Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
Placebo
Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
ALL
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
National Institutes of Health (NIH)
NIH
University of Rochester
OTHER
Responsible Party
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Edward Puzas
Dr.
Principal Investigators
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J.Edward Puzas, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester
Rochester, New York, United States
Countries
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