Testosterone Replacement Therapy in Chronic Spinal Cord Injury

This study has been completed.
Sponsor:
Collaborator:
Kessler Institute for Rehabilitation
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00266864
First received: December 15, 2005
Last updated: February 27, 2014
Last verified: February 2014
Results First Received: December 19, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Spinal Cord Injury
Hypogonadism
Intervention: Drug: Testosterone Transdermal System (Androderm 5 mg patch)

  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
Testosterone Replacement Therapy Treatment group: Testosterone Replacement Therapy Patch 5 or 10mg daily (Androderm, Watson Pharma Inc.) for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range.
No Intervention Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.

Participant Flow:   Overall Study
    Testosterone Replacement Therapy     No Intervention  
STARTED     18     13  
COMPLETED     13     11  
NOT COMPLETED     5     2  
Lost to Follow-up                 4                 1  
Withdrawal by Subject                 1                 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
Testosterone Replacement Therapy Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch)
No Intervention Subjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points.
Total Total of all reporting groups

Baseline Measures
    Testosterone Replacement Therapy     No Intervention     Total  
Number of Participants  
[units: participants]
  13     11     24  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     13     11     24  
>=65 years     0     0     0  
Gender, Customized [1]
[units: participants]
     
Male     13     11     24  
Region of Enrollment  
[units: participants]
     
United States     13     11     24  
Dual energy x-ray absorptiometry (DXA) for lean tissue mass [2]
[units: kilograms]
Mean ± Standard Deviation
  49.6  ± 7.6     51.9  ± 8.1     50.8  ± 7.8  
Resting Energy Expenditure [3]
[units: kcal/day]
Mean ± Standard Deviation
  1328  ± 262     1319  ± 112     1324  ± 197  
[1] Hypogonadal (Testosterone Replacement Therapy group, total testosterone < 4 ng/ml) and Eugonadal (No Intervention group total testosterone > 4 ng/ml) subjects
[2] Body composition measurements for measures of total body lean tissue mass (LTM) were assessed by dual energy X-ray absorptiometry (DXA; GE LUNAR Prodigy Advance, software version 11.4 and 12.2, Madison, WI). In accordance with International Society for Clinical Densitometry guidelines, total body scans were repeated on 30 SCI subjects by the “on-and-off -the-table” method (i. e., subjects were repositioned between scans) and our precision error was equal to 1.2 % for LTM.
[3] Resting Energy Expenditure was obtained by the measurement of exhaled air from fractions of mixed expired O2 and CO2 by a process known as indirect calorimetry. Data was collected under steady state conditions and t was normalized to total body lean tissue mass. Participants arrived at the laboratory for testing between the hours of 8:00 and 10:00 AM, following a 12 hour fast, with a minimum of 24 hours free from any type of exercise.



  Outcome Measures
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1.  Primary:   Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)   [ Time Frame: 12 months ]

2.  Secondary:   Resting Energy Expenditure   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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
Compared to similar trials our trial was relatively small. Although there was statistical and clinical changes associated with testosterone replacement therapy, the translation of these findings with regard to functional gain was not addressed.  


Results Point of Contact:  
Name/Title: William A. Bauman, M.D.
Organization: James J. Peters VA Medical Center
phone: 718-584-9000 ext 5428
e-mail: william.bauman@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00266864     History of Changes
Other Study ID Numbers: B2648-C
Study First Received: December 15, 2005
Results First Received: December 19, 2013
Last Updated: February 27, 2014
Health Authority: United States: Federal Government