Testosterone supplementation and bone parameters: a systematic review and meta-analysis study

Corona, Giovanni; Vena, Walter; Pizzocaro, Alessandro; Giagulli, Vito Angelo; Francomano, Davide; Rastrelli, Giulia; Mazziotti, Gherardo; Aversa, Antônio; Isidori, Andrea M.; Pivonello, Rosario; Vignozzi, Linda; Mannucci, Edoardo; Maggi, Mario; Ferlin, Alberto

doi:10.1007/s40618-021-01702-5

Cited by 28 publications

(29 citation statements)

References 96 publications

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“…The dose used in women will be one fourth that used in men (first 180 mg dose on the day of randomization, second 180-mg dose during week 4, and the third 180-mg dose during week 14). A large body of published data have shown the safety and efficacy of testosterone in increasing lean mass and strength, and bone density [ 44 , 45 ]. The participants randomized to the control group will receive an equal volume of placebo at randomization, week 4 and week 14.…”

Section: Methodsmentioning

confidence: 99%

A multimodality intervention to improve musculoskeletal health, function, metabolism, and well-being in spinal cord injury: study protocol for the FIT-SCI randomized controlled trial

Reid

Storer

Pencina

et al. 2022

BMC Musculoskelet Disord

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Background A spinal cord injury (SCI) is a devastating, life-changing event that has profoundly deleterious effects on an individual’s health and well-being. Dysregulation of neuromuscular, cardiometabolic, and endocrine organ systems following an SCI contribute to excess morbidity, mortality and a poor quality of life. As no effective treatments currently exist for SCI, the development of novel strategies to improve the functional and health status of individuals living with SCI are much needed. To address this knowledge gap, the current study will determine whether a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program that consists of functional electrical stimulation of the lower extremity during leg cycling (FES-LC) plus arm ergometry (AE) administered using behavioral motivational strategies, and testosterone therapy, is more efficacious than FES-LC plus AE and placebo in improving aerobic capacity, musculoskeletal health, function, metabolism, and wellbeing in SCI. Methods This single-site, randomized, placebo-controlled, parallel group trial will enroll 88 community-dwelling men and women, 19 to 70 years of age, with cervical and thoracic level of SCI, ASIA Impairment Scale grade: A, B, C, or D, 6 months or later after an SCI. Participants randomized to the multimodality intervention will undergo 16 weeks of home-based FES-LC and AE training plus testosterone undecanoate. Testosterone undecanoate injections will be administered by study staff in clinic or by a visiting nurse in the participant’s home. The control group will receive 16 weeks of home-based FES-LC and AE exercise plus placebo injections. The primary outcome of this trial is peak aerobic capacity, measured during an incremental exercise testing protocol. Secondary outcomes include whole body and regional lean and adipose tissue mass; muscle strength and power; insulin sensitivity, lipids, and inflammatory markers; SCI functional index and wellbeing (mood, anxiety, pain, life satisfaction and depressive symptoms); and safety. Discussion We anticipate that a multimodality intervention that simultaneously addresses multiple physiological impairments in SCI will result in increased aerobic capacity and greater improvements in other musculoskeletal, metabolic, functional and patient-reported outcomes compared to the control intervention. The findings of this study will have important implications for improving the care of people living with an SCI. Trial registration ClinicalTrials.gov: (NCT03576001). Prospectively registered: July 3, 2018.

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Section: Methodsmentioning

confidence: 99%

A multimodality intervention to improve musculoskeletal health, function, metabolism, and well-being in spinal cord injury: study protocol for the FIT-SCI randomized controlled trial

Reid

Storer

Pencina

et al. 2022

BMC Musculoskelet Disord

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“…Testosterone is an essential hormone for maintaining bone and muscle mass in men [ 5 , 6 ]. A recent review and meta-analysis study demonstrated an inhibition of bone resorption and an increased bone mass in hypogonadal patients undergoing testosterone replacement therapy [ 7 ].…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…The skeletal actions of androgens may be partially mediated via estrogen receptors (ERs) after their conversion to estrogens by the action of aromatase [ 7 ]. Therefore, testosterone action on bone is dependent on the stimulation of both androgen receptors (ARs) and ERs [ 7 , 8 ]. Moreover, it was shown that not only serum testosterone but also serum estradiol levels are important predictors of fracture risk in men [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

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A combined treatment with selective androgen and estrogen receptor modulators prevents bone loss in orchiectomized rats

Komrakova¹,

Büchler²,

Böker³

et al. 2022

J Endocrinol Invest

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Purpose Enobosarm (EN), a selective androgen receptor modulator and raloxifene (RAL), a selective estrogen receptor modulator, have been shown to improve bone tissue in osteoporotic males. The present study evaluated the effects of a combination therapy of EN and RAL on bone properties in orchiectomized rats compared to the respective single treatments. Methods Eight-month-old male Sprague–Dawley rats were either left intact (Non-Orx) or orchiectomized (Orx). The Orx rats were divided into four groups (n = 15 each): 1) Orx, 2) EN treatment (Orx + EN), 3) RAL treatment (Orx + RAL), 4) combined treatment (Orx + EN + RAL). EN and RAL (0.4 mg and 7 mg/kg body weight/day) were applied immediately after Orx with a soy-free pelleted diet for up to 18 weeks. The lumbar spine and femora were examined by micro-CT, biomechanical, histomorphological, ashing, and gene expression analyses. Results EN exhibited an anabolic effect on bone, improving some of its parameters in Orx rats, but did not affect biomechanical properties. RAL exhibited antiresorptive activity, maintaining the biomechanical and trabecular parameters of Orx rats at the levels of Non-Orx rats. EN + RAL exerted a stronger effect than the single treatments, improving most of the bone parameters. Liver weight increased after all treatments; the kidney, prostate, and levator ani muscle weights increased after EN and EN + RAL treatments. BW was reduced due to a decreased food intake in the Orx + RAL group and due a reduced visceral fat weight in the Orx + EN + RAL group. Conclusion The EN + RAL treatment appeared to be promising in preventing male osteoporosis, but given the observed side effects on liver, kidney, and prostate weights, it requires further investigation.

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“…While estrogen deficiency is generally considered to be associated with bone loss in postmenopausal women [ 5 ], age-related reduction in testosterone (T) levels might also seriously affect bone health via its action on the androgen receptor [ 6 , 7 ]. In aging men, hypogonadism is associated with reduced BMD, with androgen deprivation therapy being of potential benefit in this regard, as suggested by current guidelines [ 8 ]. Experimental data suggested that T influences bone directly via interactions with androgen receptors and indirectly via binding to estrogen receptor (ER) α and ER β after aromatization in adipose or different tissues [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

Association between Serum Total Testosterone Level and Bone Mineral Density in Middle-Aged Postmenopausal Women

Yang

Kong

Yao

et al. 2022

International Journal of Endocrinology

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Background. Hormone status strongly affects women’s health and quality of life. To date, studies investigating the association between total testosterone (T) level and bone mineral density (BMD) in women are limited and have yielded contradictory conclusions. The aim of our study was to examine the association between serum total T level and lumbar BMD in postmenopausal women aged 40–59 years. Methods. The study group included 1,058 women from the 2011–2016 National Health and Nutrition Examination Survey. Multiple regression analyses were used to evaluate the association between serum total T level and lumbar BMD. Results. After adjusting for covariates, there was a positive association between the serum total T level and lumbar BMD (β, 1.07; 95% confidence interval, 0.17–1.97). A non-linearity in this association was identified, with a point of inflection at 30 ng/dL. Conclusions. Serum total T level was positively associated with lumbar BMD in middle-aged postmenopausal women up to a T level >30 ng/dL. Therefore, increasing T level in women with a low serum total T level may have beneficial outcomes on bone health.

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Testosterone supplementation and bone parameters: a systematic review and meta-analysis study

Cited by 28 publications

References 96 publications

A multimodality intervention to improve musculoskeletal health, function, metabolism, and well-being in spinal cord injury: study protocol for the FIT-SCI randomized controlled trial

A multimodality intervention to improve musculoskeletal health, function, metabolism, and well-being in spinal cord injury: study protocol for the FIT-SCI randomized controlled trial

A combined treatment with selective androgen and estrogen receptor modulators prevents bone loss in orchiectomized rats

Association between Serum Total Testosterone Level and Bone Mineral Density in Middle-Aged Postmenopausal Women

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