Use of Teriparatide to Accelerate Fracture Healing



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:55 - Any
Updated:3/30/2013
Start Date:January 2008
End Date:November 2012
Contact:Sarah Neu, BS
Email:sarah_neu@urmc.rochester.edu
Phone:585-341-9302

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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.


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.

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
We found this trial at
1
site
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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