Use of Teriparatide to Accelerate Fracture Healing

Not Applicable

Terminated

• Conditions: Pelvic Fracture
• Interventions: Drug: Placebo; Drug: Teriparatide

• Registration Number: NCT00594906
• Lead Sponsor: University of Rochester

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-07
• Study First Posted: 2008-01-16
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2012-10-24
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-14
• Results First Posted: 2013-04-24
• Last Update Submitted: 2014-12-03
• Last Update Posted: 2014-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	30 participants will receive placebo injection pens.
Injection	Teriparatide	30 participants will receive teriparatide (Forteo) injection pens.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States