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Controlled Clinical Trial
. 2015 Jan;38(1):38-47.
doi: 10.1179/2045772314Y.0000000206. Epub 2014 Jun 26.

Lean tissue mass and energy expenditure are retained in hypogonadal men with spinal cord injury after discontinuation of testosterone replacement therapy

Controlled Clinical Trial

Lean tissue mass and energy expenditure are retained in hypogonadal men with spinal cord injury after discontinuation of testosterone replacement therapy

William A Bauman et al. J Spinal Cord Med. 2015 Jan.

Abstract

Objective: To determine whether favorable changes to lean tissue mass (LTM), resting energy expenditure (REE), and testosterone (T) that occurred with 12 months of physiological testosterone replacement therapy (TRT) were retained 6 months after discontinuing treatment.

Design: Prospective, open-label, controlled drug intervention trial.

Setting: Metropolitan area hospitals.

Subjects: Eugonadal (n = 11) and hypogonadal (n = 13) men with chronic spinal cord injury (SCI).

Interventions: Hypogonadal subjects received a 5 or 10 mg transdermal T patch daily for 12 months, with adjustment of the dose to normalize the serum T concentration; TRT was discontinued after 12 months (TRT-12M) and subjects were followed for an additional 6 months and re-evaluated (Post-TRT). Total body dual energy X-ray absorptiometry and blood draws were performed at baseline (BL) prior to TRT, TRT-12M, and Post-TRT. Eugonadal subjects did not receive treatment and were evaluated at comparable time points.

Results: There were no significant differences between groups prior to TRT at BL for any of the study endpoints. In the hypogonadal group, a significant increase in LTM was observed from BL to TRT-12M (50.2 ± 7.4 vs. 52.9 ± 6.8 kg, P < 0.01), which persisted Post-TRT compared to BL (52.2 ± 7.8 kg, P < 0.05). The increase in REE from BL to TRT-12M (1283 ± 246 vs. 1410 ± 250 kcal/day) was also retained at Post-TRT (1393 ± 220 kcal/day). These sustained improvements in LTM and REE after termination of anabolic hormonal therapy may be associated with persistent beneficial effects on health and physical function of hypogonadal men with chronic SCI.

Trial registration: ClinicalTrials.gov NCT00266864.

Keywords: Hypogonadism; Lean tissue mass; Spinal cord injury; Testosterone.

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Figures

Figure 1
Figure 1
Increase of LTM in the (A) total body (TB) and (B) leg after 12 months of T replacement therapy (TRT-12M), and retention of LTM in TB and leg 6 months after discontinuation of TRT (Post-TRT). The darker circles represent the treatment group and the lighter circles, the control group. *P < 0.05 for change from baseline, P < 0.05 for treatment vs. control.

References

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