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Randomized Controlled Trial
. 2018 Jun 14;8(1):9099.
doi: 10.1038/s41598-018-27481-3.

Effect of testosterone treatment on bone remodelling markers and mineral density in obese dieting men in a randomized clinical trial

Mark Ng Tang Fui  1   2 , Rudolf Hoermann  1 , Brendan Nolan  2 , Michelle Clarke  1 , Jeffrey D Zajac  1   2 , Mathis Grossmann  3   4
Affiliations
Randomized Controlled Trial

Effect of testosterone treatment on bone remodelling markers and mineral density in obese dieting men in a randomized clinical trial

Mark Ng Tang Fui et al. Sci Rep. .

Abstract

To assess the effect of testosterone treatment on bone remodelling and density in dieting obese men, 100 obese men aged 53 years (interquartile range 47-60) with a total testosterone level <12 nmol/L receiving 10 weeks of a very low energy diet (VLED) followed by 46 weeks of weight maintenance were randomly assigned at baseline to 56 weeks of intramuscular testosterone undecanoate (n = 49, cases) or matching placebo (n = 51, controls). Pre-specified outcomes were between-group differences (mean adjusted difference, MAD) in serum c-telopeptide (CTx), N-terminal propeptide of type 1 procollagen (P1NP) and bone mineral density (BMD). At trial end, CTx was significantly reduced in men receiving testosterone compared to placebo, MAD -66 ng/L (95% CI -113, -18), p = 0.018, and this was apparent already after the 10 week VLED phase, MAD -63 ng/L (95% CI -108, -18), p = 0.018. P1NP was marginally increased after VLED, MAD +4.2 ug/L (95% CI -0.01, +8.4), p = 0.05 but lower at study end, MAD -5.6 ug/L (95% CI -10.1, -1.1), p = 0.03. No significant changes in sclerostin, lumbar spine BMD or femoral BMD were seen. We conclude that in obese men with low testosterone levels undergoing weight loss, bone remodelling markers are modulated in a way that may have favourable effects on bone mass.

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Conflict of interest statement

Mathis Grossmann has received research funding from Bayer Pharma, Novartis, Weight Watchers, Lilly and speaker’s honoraria from Besins Healthcare. Mark Ng Tang Fui has received research funding from Bayer Pharma. Rudolf Hoermann, Brendan Nolan, Michelle Clarke and Jeffrey D. Zajac declare that they have no competing interests.

Figures

Figure 1
Figure 1
Shown are adjusted mean (95% CI) circulating CTx (A), P1NP (B) and sclerostin (C) levels in testosterone- (solid lines) and placebo- (dashed lines) treated men at baseline (week 0), after the 10 week VLED phase (week 10), and after the subsequent 46 week maintenance phase (week 56, study end) of the trial.
Figure 2
Figure 2
Shown are adjusted mean (95% CI) BMD at the lumbar spine (A), femoral neck (B) and total femur (C) in testosterone- (solid lines) and placebo- (dashed lines) treated men at baseline (week 0), after the 10 week VLED phase (week 10), and after the subsequent 46 week maintenance phase (week 56, study end) of the trial.
See this image and copyright information in PMC

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