Use of Teriparatide to Accelerate Fracture Healing - Full Text View

Purpose

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

Condition	Intervention
Pelvic Fracture	Drug: Teriparatide Drug: Placebo

MedlinePlus related topics:

Fractures

ChemIDplus related topics:

Teriparatide Teriparatide acetate

U.S. FDA Resources

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

Further study details as provided by University of Rochester:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Radiologic evidence of callus formation. [ Time Frame: 0 & 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 Forteo (teriparatide) injection pens.	Drug: Teriparatide Daily 20 mcg subcutaneous injections for duration of the study (16 weeks).
2: Placebo Comparator 30 participants will be given placebo injection pens.	Drug: Placebo Daily 20 mcg subcutaneous injections for the duration fo the study (16 weeks).

Detailed Description:

Patients who participate in this study, will be assigned randomly to receive Forteo or a placebo. Participants will be given calcium and vitamin D supplements to take daily throughout the study. At 4 week intervals during the study, participants will undergo functional evaluations (to 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, CT evaluation upon enrollment and 16 weeks post-fracture, and will be asked to 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:

male or femail at or over the age of 55
females must be menopausal (no menses within the last 12 months)
all races included
low energy fragility fractures of the pelvis, including anterior column, posterior column, inferior or superior rami or sacrum
maximum of two weeks post fracture
mental status consistent with completing the protocol

Exclusion Criteria:

subjects on any treatment for osteoporosis including estrogen and estrogenic-like compounds
radiation treatment to any site at any time in the past
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, GI, liver or metabolic bone disease
pregnancy
high calcium, parathyroid hormone or alkaline phosphatase 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

Responsible Party:	University of Rochester ( J. Edward Puzas, PhD )
Study ID Numbers:	12801, P50AR054041
First Received:	January 7, 2008
Last Updated:	January 7, 2008
ClinicalTrials.gov Identifier:	NCT00594906
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by University of Rochester:

Fracture Healing

Teriparatide

Forteo

Pelvic Fractures

Study placed in the following topic categories:

Teriparatide

Fractures, Bone

Wounds and Injuries

Disorders of Environmental Origin

Additional relevant MeSH terms:

Physiological Effects of Drugs

Bone Density Conservation Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	University of Rochester National Institutes of Health (NIH)
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00594906