Use of Teriparatide to Accelerate Fracture Healing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use of Teriparatide to Accelerate Fracture Healing

Conditions
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Pelvic Fracture

Intervention / Treatment
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* Drug: Teriparatide
* Drug: Placebo


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Injection<br>30 participants will receive teriparatide (Forteo) injection pens. | Drug: Teriparatide<br>* Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)<br>* Other names: Forteo;|
| Placebo Comparator: Placebo<br>30 participants will receive placebo injection pens. | Drug: Placebo<br>* Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of a Fracture From a Low Energy Fall | Callus formation at the fracture site as defined by a CT scan to determine healing (early/beginning callus formation) or healed (complete callus formation) | Measured at 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fracture Healing, Teriparatide, Forteo, Pelvic Fractures