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Horm Metab Res 2011; 43(08): 574-579
DOI: 10.1055/s-0031-1280797
Humans, Clinical
Georg Thieme Verlag KG Stuttgart · NewYork

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
1   VA RR & D National Center of Excellence for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY, USA
2   Medical Service, James J. Peters VA Medical Center, Bronx, NY, USA
3   Department of Medicine, The Mount Sinai School of Medicine, New York, NY, USA
4   Department of Rehabilitation Medicine, The Mount Sinai School of Medicine, New York, NY, USA
,
C.M. Cirnigliaro
1   VA RR & D National Center of Excellence for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY, USA
,
M.F. La Fountaine
1   VA RR & D National Center of Excellence for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY, USA
2   Medical Service, James J. Peters VA Medical Center, Bronx, NY, USA
3   Department of Medicine, The Mount Sinai School of Medicine, New York, NY, USA
,
A.M. Jensen
1   VA RR & D National Center of Excellence for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY, USA
,
J.M. Wecht
1   VA RR & D National Center of Excellence for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY, USA
2   Medical Service, James J. Peters VA Medical Center, Bronx, NY, USA
4   Department of Rehabilitation Medicine, The Mount Sinai School of Medicine, New York, NY, USA
,
S.C. Kirshblum
5   Kessler Institute for Rehabilitation, West Orange, NJ, USA
6   Department of Physical Medicine and Rehabilitation,, University of Medicine and Dentistry of New Jersey, Newark, NJ, USA
,
A.M. Spungen
1   VA RR & D National Center of Excellence for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY, USA
2   Medical Service, James J. Peters VA Medical Center, Bronx, NY, USA
3   Department of Medicine, The Mount Sinai School of Medicine, New York, NY, USA
4   Department of Rehabilitation Medicine, The Mount Sinai School of Medicine, New York, NY, USA
› Author Affiliations
Further Information

Publication History

received 10 March 2011

accepted 25 May 2011

Publication Date:
29 June 2011 (online)

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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 10 mg) 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 (49.6 ± 7.6 vs. 53.1 ± 6.9 kg; p < 0.0005), trunk (24.1 ± 4.1 vs. 25.8 ± 3.8 kg; p < 0.005), leg (14.5 ± 2.7 vs. 15.8 ±2.6  kg; p = 0.005), and arm (7.6 ± 2.3 vs. 8.0 ± 2.2 kg; p < 0.005) from baseline to month 12. After testosterone replacement therapy, resting energy expenditure (1328 ± 262 vs. 1440 ± 262 kcal/d; p < 0.01) and percent predicted basal energy expenditure (73 ± 9 vs. 79 ± 10%; 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.

Key words

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

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