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Use of Teriparatide to Accelerate Fracture Healing

This study is currently recruiting participants.
Verified by University of Rochester, January 2008

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




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