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Cited by 65Hormonal and reproductive studiesBone health and osteoporosis researchMenopause: Health Impacts and Treatments

Effects of aromatase inhibition vs. testosterone in older men with low testosterone: randomized‐controlled trial

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Dias, J. P., Melvin, D., Simonsick, E.M., Carlson, O., Shardell, M.D., Ferrucci, L., Chia, C. W., Basaria, S. +1 more·2016·Andrology
DOI 10.1111/andr.12126PMC PMC5836312
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Abstract

Summary: Aging in men is associated with loss of bone mass, impaired physical function and altered body composition. The objective of this proof‐of‐concept randomized, double‐blind, placebo‐controlled, parallel‐group, single‐center trial was to determine the relative effects of testosterone (T) and estradiol (E 2 ) on bone mineral density, body composition, and physical performance in older men. The primary outcome was lumbar spine bone mineral density ( BMD ), and secondary outcomes were body composition, muscle strength, gait speed, and sex hormone concentrations. Forty three men (age range, 65–82 years; mean age 71 years) with low total T levels <350 ng/dL were randomized to one of three groups: 5 g transdermal testosterone gel ( TT ) ( N = 16), anastrozole ( AI ) 1 mg ( N = 14) or placebo daily ( N = 13) for 12 months. Outcomes were assessed at baseline, 3, 6, and 12 months. Both TT and AI increased serum TT levels (>500 ng/dL, p < 0.05) compared to baseline; T values remained stable throughout the duration of the trial. At 12 months, TT improved the primary outcome of lumbar spine BMD ( p < 0.01).Both interventions improved knee strength at 12 months compared to baseline ( p < 0.05) while lean body mass significantly increased only in the AI group at 6 and 12 months (1.49 ± 0.38 kg, p < 0.01; 1.24 ± 0.39 kg, p < 0.05, respectively) compared to baseline. Interestingly, TT improved fast gait speed at 3 and 12 months ( p < 0.01, p < 0.05, respectively). In summary, this proof‐of‐concept study confirms that aromatization of T is required for maintaining BMD in older men with low‐T levels. The trial also uncovered the novel finding that aromatization of T is required for improvement in fast gait speed, an observation that needs to be verified in future studies.

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  • AIs are associated with lower bone mineral density compared to TRT and placebo.

    “Most importantly, AIs are associated with lower bone mineral density compared to TRT and placebo.”

    From Treatment of Men with Central Hypogonadism: Alternatives for Testosterone Replacement Therapy (2020) · cites this paper as [68]

    The Discussion reports lower lumbar spine BMD after 12 months of aromatase-inhibitor treatment than with testosterone or placebo. The Results specify that the difference was in lumbar spine BMD; femoral neck BMD did not change significantly. The claim omits that site-specific qualification. (LLM, conf=0.85)

    Experimental — accuracy not yet measured

  • AIs have been shown to raise testosterone levels in hypogonadal men and are orally administered.

    “These compounds have been shown to raise testosterone levels in hypogonadal men and are also orally administered (64-66).”

    From Non-testosterone management of male hypogonadism: an examination of the existing literature (2020) · cites this paper as [66]

  • In 14 hypogonadal men treated with 1 mg anastrozole daily for 12 months, total testosterone significantly increased, and lumbar spine bone mineral density was lower compared to men on testosterone therapy.

    “Dias et al. treated 14 hypogonadal men with 1 mg of anastrozole daily for 12 months. Men treated with AI had significant increases in total testosterone levels over the study course. Of note, lumbar spine bone mineral density was lower in men treated with AI compared to those on testosterone therapy (66).”

    From Non-testosterone management of male hypogonadism: an examination of the existing literature (2020) · cites this paper as [66]

  • The lower bone mineral density with AIs can be explained by AIs lowering estrogen levels, which are important for the maintenance of bone mineral density in men.

    “This can be explained by the fact that AIs lower estrogen levels, which are important for the maintenance of bone mineral density in men [68].”

    From Treatment of Men with Central Hypogonadism: Alternatives for Testosterone Replacement Therapy (2020) · cites this paper as [68]

  • Aromatase inhibitors such as anastrozole have been reported to increase fat loss when combined with weight loss programs in men affected by obesity and in a RCT of older men with hypogonadism.

    “Aromatase inhibitors such as anastrozole have been reported to increase fat loss when combined with weight loss programs in men affected by obesity 198 and in a RCT of older men with hypogonadism.”

    From The role of the androgen receptor in the pathogenesis of obesity and its utility as a target for obesity treatments (2022) · cites this paper as [199]

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Authors
Dias, J. P., Melvin, D., Simonsick, E. M., Carlson, O., Shardell, M. D., Ferrucci, L., Chia, C. W., Basaria, S., & Egan, J. M.
Affiliations
  • National Institute on Aging (US)
  • Brigham and Women's Hospital (US)
Corresponding author
  • Chia, C. W.
  • Basaria, S.
ORCID
Venue
Andrology
Publisher
Wiley
Published
2015-11-20
Volume
4
Issue
1
Pages
33-40
ISSN
  • 2047-2919 (ISSN-L)
  • 2047-2927
DOI
10.1111/andr.12126
PMC
PMC5836312
OpenAlex
W2179692520
Cited by
65
References
42
Citations by year
2026: 5 · 2025: 5 · 2024: 6 · 2023: 8 · 2022: 12 · 2021: 2 · 2020: 11 · 2019: 3 · 2018: 4 · 2017: 6 · 2016: 3
FWCI
3.77
Type
journal article
Language
en
Open access
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • Andrology (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
National Institute on Aging
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
  • Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
Keywords
testosterone replacement therapy, aromatase inhibition, anastrozole, androgen deficiency, older men, bone mineral density, lumbar spine, estradiol, aromatization, body composition, lean body mass, muscle strength, walking speed, aging
MeSH terms
Anastrozole, Aged, Aged, 80 and over, Aging, Aromatase, Body Composition, Bone and Bones, Double-Blind Method, Estradiol, Humans, Male, Nitriles, Placebos, Testosterone, Triazoles, Bone Density, Aromatase Inhibitors

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