Testosterone Replacement Therapy in Chronic Spinal Cord Injury
It has long been recognized that co-morbidity associated with multiple metabolic syndrome, such as adverse body composition, insulin resistance and autonomic nervous system impairment, may lead to significant increase in cardiovascular morbidity and mortality. It is unclear whether the co-morbidity evident in this population are due directly to their immobility or are the result of unfavorable changes in their underlying hormonal milieu. The purpose of this study is to determine the effect of testosterone replacement therapy in hypogonadal males on:
body composition, i.e. lean tissue and fat mass, glucose tolerance, resting energy expenditure, autonomic-cardiovascular integrity, muscular strength, psychological assessment
|Spinal Cord Injury Hypogonadism||Drug: Testosterone Transdermal System (Androderm 5 mg patch)||Phase 2 Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Testosterone Replacement Therapy in Chronic Spinal Cord Injury|
- Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM) [ Time Frame: 12 months ]Dual energy X-ray absorptiometry assessment of lean tissue mass (LTM) at 12 months. Total body scans were performed and the energy level used for each total body scan was based on subject thickness (e. g., thin, standard, or thick). To analyze the results of each total body scan, proprietary software algorithms were used to segment the body into trunk, pelvis, and upper and lower extremities using the standard regions of interest. In accordance with International Society for Clinical Densitometry guidelines, total body scans were repeated on 30 spinal cord injury 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.
- Resting Energy Expenditure [ Time Frame: 12 months ]Resting Energy Expenditure was obtained by the measurement of exhaled air from fractions of mixed expired oxygen and carbon dioxide by a process known as indirect calorimetry. Data was collected under steady state conditions. Participants arrived at the laboratory for testing between the hours of 8:00 and 10:00 in the morning, following a 12-h fast, with a minimum of 24 h free from any type of exercise.
|Study Start Date:||August 2003|
|Study Completion Date:||December 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: Testosterone Replacement Therapy
Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch)
Drug: Testosterone Transdermal System (Androderm 5 mg patch)
Testosterone Transdermal System (Androderm 5 mg patch)
Other Name: Androgel (Testim) and Underarm Testosterone (Axiron)
Placebo Comparator: No Intervention
Subjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points.
This study is 24 months in duration. Men who have consented to pre-screening serum testosterone draw and are found to have total testosterone levels averaging ≤ 11.3 nmol/l will start testosterone replacement therapy after a 6-month baseline period. Once treatment begins subjects will place a testosterone replacement patch (5 or 10 mg/day) on various sites of the body daily. Subjects will visit the lab after 2,6, 12, and 18 months of therapy for testing; however they will stop taking the patch at the 12 month visit. If needed, a steroid cream will be provided to the subjects should any skin irritations occur. If the patch causes persistent skin irritations, despite use of the steroid cream, then a testosterone gel may be used. Detailed instructions and precautions using the gel are outlined in the consent form and will be reviewed with the subject.
Those men who have consented to pre-screening serum testosterone and are found to have normal levels of total testosterone (testosterone total ≥ 11.4 nmol/l) are eligible to participate as a control subject for the full 24-month period of the study. These subjects visit the lab at baseline (BL), 12 and 24 months for the same testing as those in the treatment group.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266864
|United States, New Jersey|
|Kessler Institute for Rehabilitation|
|West Orange, New Jersey, United States, 07052|
|United States, New York|
|James J. Peters VA Medical Center|
|Bronx, New York, United States, 10468|
|Principal Investigator:||William Bauman, MD||VA Medical Center, Bronx|