A small-scale clinical trial to determine the safety and efficacy of testosterone replacement therapy in hypogonadal men with spinal cord injury

W. A. Bauman, C. M. Cirnigliaro, M. F. La Fountaine, A. M. Jensen, J. M. Wecht, S. C. Kirshblum, A. M. Spungen

Research output: Contribution to journalReview articlepeer-review

46 Scopus citations

Abstract

Men with spinal cord injury are at an increased risk for secondary medical conditions, including metabolic disorders, accelerated musculoskeletal atrophy, and, for some, hypogonadism, a deficiency, which may further adversely affect metabolism and body composition. A prospective, open label, controlled drug intervention trial was performed to determine whether 12 months of testosterone replacement therapy increases lean tissue mass and resting energy expenditure in hypogonadal males with spinal cord injury. Healthy eugonadal (n=11) and hypogonadal (n=11) outpatients with chronic spinal cord injury were enrolled. Hypogonadal subjects received transdermal testosterone (5 or 10mg) daily for 12 months. Measurements of body composition and resting energy expenditure were obtained at baseline and 12 months. The testosterone replacement therapy group increased lean tissue mass for total body (49.67.6 vs. 53.16.9kg; p<0.0005), trunk (24.14.1 vs. 25.83.8kg; p<0.005), leg (14.52.7 vs. 15.82.6kg; p=0.005), and arm (7.62.3 vs. 8.02.2kg; p<0.005) from baseline to month 12. After testosterone replacement therapy, resting energy expenditure (1328262 vs. 1440262kcal/d; p<0.01) and percent predicted basal energy expenditure (739 vs. 7910%; p<0.05) were significantly increased. In conclusion, testosterone replacement therapy significantly improved lean tissue mass and energy expenditure in hypogonadal men with spinal cord injury, findings that would be expected to influence the practice of clinical care, if confirmed. Larger, randomized, controlled clinical trials should be performed to confirm and extend our preliminary findings.

Original languageEnglish
Pages (from-to)574-579
Number of pages6
JournalHormone and Metabolic Research
Volume43
Issue number8
DOIs
StatePublished - 2011

Keywords

  • androgen replacement therapy
  • hypogonadism
  • lean tissue mass
  • paraplegia
  • tetraplegia

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