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: April 8, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Spinal Cord Injury
Hypogonadism
Drug: Testosterone Transdermal System (Androderm 5 mg patch)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Testosterone Replacement Therapy in Chronic Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Resting Energy Expenditure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 31
Study Start Date: August 2003
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266864

Locations
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
Sponsors and Collaborators
Kessler Institute for Rehabilitation
Investigators
Principal Investigator: William Bauman, MD VA Medical Center, Bronx
  More Information

Additional Information:
Publications:
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: April 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Spinal Cord Injury
Testosterone Replacement Therapy
Dual Energy X ray Absorptiometry
Lean Tissue Mass

Additional relevant MeSH terms:
Hypogonadism
Spinal Cord Injuries
Wounds and Injuries
Gonadal Disorders
Endocrine System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 26, 2014