Use of Teriparatide to Accelerate Fracture Healing

This study has been terminated.
(The study was terminated due to poor enrollment.)
Sponsor:
Collaborators:
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
Results First Received: October 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pelvic Fracture
Interventions: Drug: Teriparatide
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Forteo Injection

30 participants will receive teriparatide (Forteo) injection pens.

Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)

Placebo Injection

30 participants will receive placebo injection pens.

Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)


Participant Flow:   Overall Study
    Forteo Injection     Placebo Injection  
STARTED     7     3  
COMPLETED     6     1  
NOT COMPLETED     1     2  
Physician Decision                 1                 0  
Physician Decision                 0                 1  
Death                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Injection

30 participants will receive teriparatide (Forteo) injection pens.

Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)

Placebo

30 participants will receive placebo injection pens.

Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)

Total Total of all reporting groups

Baseline Measures
    Injection     Placebo     Total  
Number of Participants  
[units: participants]
  7     3     10  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     1     3  
>=65 years     5     2     7  
Age  
[units: years]
Mean ± Standard Deviation
  78  ± 14     66  ± 5     75  ± 13  
Gender  
[units: participants]
     
Female     7     3     10  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     7     3     10  



  Outcome Measures

1.  Primary:   Healing of a Fracture From a Low Energy Fall   [ Time Frame: Measured at 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small numbers of subjects analyzed.  


Results Point of Contact:  
Name/Title: Dr. J. Edward Puzas
Organization: University of Rochester
phone: (585) 275-3664
e-mail: edward_puzas@urmc.rochester.edu


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