Testosterone Replacement Therapy in Chronic Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Testosterone Replacement Therapy in Chronic Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266864
• Other study ID #: B2648-C
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 15, 2005
• Last updated: September 29, 2017
• Start date: August 2003
• Est. completion date: December 2012

Study information

• Verified date: September 2017
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Males 18-49 years of age

• Chronic spinal cord injury

• Normal prostate specific antigen levels and digital rectal exam

• No known cardiovascular disease

• Subjects with total testosterone > 4 ng/ml

• Subjects with total testosterone > 4 ng/ml

Exclusion Criteria:

• Females

• Known coronary heart and/or artery disease, diabetes mellitus

• Previous or current cancer

• Current or previous anabolic steroid use

• Acute inter-current illness

• Abnormal liver function test (>1.5 times normal values) at baseline

• Prostate specific antigen above normal

• Abnormal digital rectal exam at baseline suggestive of malignancy

• Current alcohol or drug abuse

• Significant psychological disorders

Related Conditions & MeSH terms

• Hypogonadism
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Drug:
• Testosterone Transdermal System (Androderm 5 mg patch)
Testosterone Transdermal System (Androderm 5 mg patch)

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center	The Bronx	New York
United States	Kessler Institute for Rehabilitation	West Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Kessler Institute for Rehabilitation

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bauman WA, Cirnigliaro CM, La Fountaine MF, Jensen AM, Wecht JM, Kirshblum SC, Spungen AM. A small-scale clinical trial to determine the safety and efficacy of testosterone replacement therapy in hypogonadal men with spinal cord injury. Horm Metab Res. 20 — View Citation

La Fountaine MF, Wecht JM, Cirnigliaro CM, Kirshblum SC, Spungen AM, Bauman WA. QT/RR coherence is associated with testosterone levels in men with chronic spinal cord injury. Neuroendocrinology. 2011;93(3):174-80. doi: 10.1159/000323773. Epub 2011 Jan 21. — View Citation

La Fountaine MF, Wecht JM, Cirnigliaro CM, Kirshblum SC, Spungen AM, Bauman WA. Testosterone replacement therapy improves QTaVI in hypogonadal men with spinal cord injury. Neuroendocrinology. 2013;97(4):341-6. doi: 10.1159/000347070. Epub 2013 May 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)	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.	12 months
Secondary	Resting Energy Expenditure	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.	12 months

External Links

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