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Use of Teriparatide to Accelerate Fracture Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00594906
Recruitment Status : Terminated (The study was terminated due to poor enrollment.)
First Posted : January 16, 2008
Results First Posted : April 24, 2013
Last Update Posted : December 19, 2014
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Edward Puzas, University of Rochester

Study Description
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Brief Summary:
The purpose of this study is to compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing.

Condition or disease Intervention/treatment Phase
Pelvic Fracture Drug: Teriparatide Drug: Placebo Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Teriparatide to Accelerate Fracture Healing
Study Start Date : January 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Injection
30 participants will receive teriparatide (Forteo) injection pens.
 Drug: Teriparatide
Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
Other Name: Forteo
Placebo Comparator: Placebo
30 participants will receive placebo injection pens.
 Drug: Placebo
Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)


Outcome Measures
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Primary Outcome Measures :
  1. Healing of a Fracture From a Low Energy Fall [ Time Frame: Measured at 16 weeks ]
    Callus formation at the fracture site as defined by a CT scan to determine healing (early/beginning callus formation) or healed (complete callus formation)


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594906


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: J.Edward Puzas, PhD University of Rochester
More Information
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Responsible Party: Edward Puzas, Dr., University of Rochester
ClinicalTrials.gov Identifier: NCT00594906    
Other Study ID Numbers: P50AR054041 ( U.S. NIH Grant/Contract )
P50AR054041 ( U.S. NIH Grant/Contract )
First Posted: January 16, 2008    Key Record Dates
Results First Posted: April 24, 2013
Last Update Posted: December 19, 2014
Last Verified: March 2013
Keywords provided by Edward Puzas, University of Rochester:
Fracture Healing
Teriparatide
Forteo
Pelvic Fractures
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
 Leg Injuries
Teriparatide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents