Use of Teriparatide to Accelerate Fracture Healing - Full Text View

Sponsor:	University of Rochester
Collaborator:	National Institutes of Health (NIH)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00594906

Purpose

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

Condition	Intervention
Pelvic Fracture	Drug: Teriparatide Drug: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Use of Teriparatide to Accelerate Fracture Healing

Resource links provided by NLM:

MedlinePlus related topics: Fractures

Drug Information available for: Teriparatide Teriparatide acetate

U.S. FDA Resources

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

Accelerated fracture healing of low energy fragility fractures, as based on motion analysis measurement [ Time Frame: Measured at 0, 4, 8, 12, and 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Radiologic evidence of callus formation [ Time Frame: Measured at 0 and 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 30 participants will receive teriparatide (Forteo) injection pens.	Drug: Teriparatide Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
2: Placebo Comparator 30 participants will receive placebo injection pens.	Drug: Placebo Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)

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

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594906

Contacts

Contact: Kelly Unsworth, BS

585-273-1465

Kelly_Unsworth@urmc.rochester.edu

Locations

United States, New York
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Contact: Kelly Unsworth, BS 585-273-1465 Kelly_Unsworth@urmc.rochester.edu
Sub-Investigator: Susan Bukata, MD
Sub-Investigator: John Gorczyca, MD
Sub-Investigator: Jeff Houck, PhD, PT
Sub-Investigator: Barbara Gracious, MD
Sub-Investigator: Christopher Beck, PhD

Sponsors and Collaborators

University of Rochester

National Institutes of Health (NIH)

Investigators

Principal Investigator:

J.Edward Puzas, PhD

University of Rochester

More Information

No publications provided

Responsible Party:	University of Rochester ( J. Edward Puzas, PhD )
Study ID Numbers:	P50 AR054041, 12801
Study First Received:	January 7, 2008
Last Updated:	May 11, 2009
ClinicalTrials.gov Identifier:	NCT00594906 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Fracture Healing
Teriparatide
Forteo
Pelvic Fractures

Additional relevant MeSH terms:

Teriparatide
Physiological Effects of Drugs
Fractures, Bone
Wounds and Injuries

Disorders of Environmental Origin
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009