Use of Teriparatide to Accelerate Fracture Healing

Pelvic Fracture Clinical Trial

Official title:

Use of Teriparatide to Accelerate Fracture Healing

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00594906
• Other study ID #: P50AR054041
• Secondary ID: P50AR054041
• Status: Terminated
• Phase: N/A
• First received: January 7, 2008
• Last updated: December 3, 2014
• Start date: January 2008
• Est. completion date: July 2012

Study information

• Verified date: March 2013
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Pelvic Fracture

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No