Clinical trial NCT00266864: Testosterone Replacement Therapy in Chronic Spinal Cord Injury
Official title: Testosterone Replacement Therapy in Chronic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Spinal Cord Injury
Hypogonadism
Keywords: Spinal Cord Injury
Testosterone Replacement Therapy
Dual Energy X ray Absorptiometry
Lean Tissue Mass
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Kessler Institute for Rehabilitation
First posted: 2005-12-19
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)
timeFrame: 12 months
Secondary outcomes:
measure: Resting Energy Expenditure
timeFrame: 12 months
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
city: The Bronx
country: United States
facility: James J. Peters VA Medical Center
state: New York
Study officials:
affiliation: VA Medical Center, Bronx
name: William Bauman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2011 Jul;43(8):574-9. doi: 10.1055/s-0031-1280797. Epub 2011 Jun 29.
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.
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.
citation: Bauman WA, La Fountaine MF, Cirnigliaro CM, Kirshblum SC, Spungen AM. Lean tissue mass and energy expenditure are retained in hypogonadal men with spinal cord injury after discontinuation of testosterone replacement therapy. J Spinal Cord Med. 2015 Jan;38(1):38-47. doi: 10.1179/2045772314Y.0000000206. Epub 2014 Jun 26.