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Use of Teriparatide to Accelerate Fracture Healing

This study has been terminated.
(The study was terminated due to poor enrollment.)
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00594906
First received: January 7, 2008
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Teriparatide to Accelerate Fracture Healing

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Healing of a Fracture From a Low Energy Fall [ Time Frame: Measured at 16 weeks ] [ Designated as safety issue: No ]
    Callus formation at the fracture site as defined by a CT scan to determine healing (early/beginning callus formation) or healed (complete callus formation)


Enrollment: 10
Study Start Date: January 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Locations
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
Principal Investigator: J.Edward Puzas, PhD University of Rochester
  More Information

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00594906     History of Changes
Other Study ID Numbers: P50 AR054041, P50AR054041
Study First Received: January 7, 2008
Results First Received: October 24, 2012
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Fracture Healing
Teriparatide
Forteo
Pelvic Fractures

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Teriparatide
 Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013