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Use of Teriparatide to Accelerate Fracture Healing

Information source: University of Rochester
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pelvic Fracture

Intervention: Teriparatide (Drug); Placebo (Drug)

Phase: N/A

Status: Terminated

Sponsored by: University of Rochester

Official(s) and/or principal investigator(s):
J.Edward Puzas, PhD, Principal Investigator, Affiliation: University of Rochester

Summary

The purpose of this study is to compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing.

Clinical Details

Official title: Use of Teriparatide to Accelerate Fracture Healing

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Healing of a Fracture From a Low Energy Fall

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.

Eligibility

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

University of Rochester, Rochester, New York 14642, United States
Additional Information

Starting date: January 2008
Last updated: December 3, 2014

Page last updated: August 20, 2015

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