Full Text View
Tabular View
No Study Results Posted
Related Studies
Use of Teriparatide to Accelerate Fracture Healing
This study is currently recruiting participants.
Verified by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), May 2009
First Received: January 7, 2008   Last Updated: May 11, 2009   History of Changes
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:


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
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