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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:
ClinicalTrials.gov Identifier:
NCT00594906
First Posted: January 16, 2008
Last Update Posted: December 19, 2014
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.
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
January 7, 2008
January 16, 2008
October 24, 2012
April 24, 2013
December 19, 2014
January 2008
July 2012   (Final data collection date for primary outcome measure)
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)
Accelerated fracture healing of low energy fragility fractures based on motion analysis measurement. [ Time Frame: 0, 4, 8, 12 & 16 weeks ]
Complete list of historical versions of study NCT00594906 on ClinicalTrials.gov Archive Site
Not Provided
Radiologic evidence of callus formation. [ Time Frame: 0 & 16 weeks ]
Not Provided
Not Provided
 
Use of Teriparatide to Accelerate Fracture Healing
Use of Teriparatide to Accelerate Fracture Healing
The purpose of this study is to compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pelvic Fracture
  • Drug: Teriparatide
    Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
    Other Name: Forteo
  • Drug: Placebo
    Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
  • Active Comparator: Injection
    30 participants will receive teriparatide (Forteo) injection pens.
    Intervention: Drug: Teriparatide
  • Placebo Comparator: Placebo
    30 participants will receive placebo injection pens.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
July 2012
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00594906
P50AR054041( U.S. NIH Grant/Contract )
P50AR054041 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Edward Puzas, University of Rochester
University of Rochester
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • National Institutes of Health (NIH)
Principal Investigator: J.Edward Puzas, PhD University of Rochester
University of Rochester
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP