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Cited by 239Hormonal and reproductive studiesErythropoietin and Anemia TreatmentIron Metabolism and Disorders

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Association of Testosterone Levels With Anemia in Older Men: A Controlled Clinical Trial

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Roy, Cindy N., Snyder, Peter J., Stephens-Shields, Alisa J., Artz, Andrew S., Bhasin, Shalender, Cohen, Harvey J., Farrar, John T., Gill, Thomas M., Zeldow, Bret, Cella, David, Barrett-Connor, Elizabeth, Cauley, Jane A., Crandall, Jill P., Cunningham, Glenn R., Ensrud, Kristine E., Lewis, Cora E., Matsumoto, Alvin M., Molitch, Mark E., Pahor, Marco, Swerdloff, Ronald S., Cifelli, Denise, Hou, Xiaoling, Resnick, Susan M., Walston, Jeremy D., Anton, Stephen, Basaria, Shehzad, Diem, Susan J., Wang, Christina, Schrier, Stanley L., Ellenberg, Susan S.·2017·JAMA Internal Medicine
DOI 10.1001/jamainternmed.2016.9540PMC PMC5433757
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Abstract

Importance: In one-third of older men with anemia, no recognized cause can be found. Objective: To determine if testosterone treatment of men 65 years or older with unequivocally low testosterone levels and unexplained anemia would increase their hemoglobin concentration. Design, Setting, and Participants: A double-blinded, placebo-controlled trial with treatment allocation by minimization using 788 men 65 years or older who have average testosterone levels of less than 275 ng/dL. Of 788 participants, 126 were anemic (hemoglobin ≤12.7 g/dL), 62 of whom had no known cause. The trial was conducted in 12 academic medical centers in the United States from June 2010 to June 2014. Interventions: Testosterone gel, the dose adjusted to maintain the testosterone levels normal for young men, or placebo gel for 12 months. Main Outcomes and Measures: The percent of men with unexplained anemia whose hemoglobin levels increased by 1.0 g/dL or more in response to testosterone compared with placebo. The statistical analysis was intent-to-treat by a logistic mixed effects model adjusted for balancing factors. Results: The men had a mean age of 74.8 years and body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) of 30.7; 84.9% were white. Testosterone treatment resulted in a greater percentage of men with unexplained anemia whose month 12 hemoglobin levels had increased by 1.0 g/dL or more over baseline (54%) than did placebo (15%) (adjusted OR, 31.5; 95% CI, 3.7-277.8; P = .002) and a greater percentage of men who at month 12 were no longer anemic (58.3%) compared with placebo (22.2%) (adjusted OR, 17.0; 95% CI, 2.8-104.0; P = .002). Testosterone treatment also resulted in a greater percentage of men with anemia of known cause whose month 12 hemoglobin levels had increased by 1.0 g/dL or more (52%) than did placebo (19%) (adjusted OR, 8.2; 95% CI, 2.1-31.9; P = .003). Testosterone treatment resulted in a hemoglobin concentration of more than 17.5 g/dL in 6 men who had not been anemic at baseline. Conclusions and Relevance: Among older men with low testosterone levels, testosterone treatment significantly increased the hemoglobin levels of those with unexplained anemia as well as those with anemia from known causes. These increases may be of clinical value, as suggested by the magnitude of the changes and the correction of anemia in most men, but the overall health benefits remain to be established. Measurement of testosterone levels might be considered in men 65 years or older who have unexplained anemia and symptoms of low testosterone levels. Trial Registration: clinicaltrials.gov Identifier: NCT00799617.

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Authors
Roy, C. N., Snyder, P. J., Stephens-Shields, A. J., Artz, A. S., Bhasin, S., Cohen, H. J., Farrar, J. T., Gill, T. M., Zeldow, B., Cella, D., Barrett-Connor, E., Cauley, J. A., Crandall, J. P., Cunningham, G. R., Ensrud, K. E., Lewis, C. E., Matsumoto, A. M., Molitch, M. E., Pahor, M., Swerdloff, R. S., Cifelli, D., Hou, X., Resnick, S. M., Walston, J. D., Anton, S., Basaria, S., Diem, S. J., Wang, C., Schrier, S. L., & Ellenberg, S. S.
Affiliations
  • Johns Hopkins University (US)
  • University of Pennsylvania (US)
  • Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia
  • University of Chicago (US)
  • Brigham and Women's Hospital (US)
  • Duke Medical Center (US)
  • Yale University (US)
  • Northwestern University (US)
  • University of California San Diego (US)
  • University of Pittsburgh (US)
  • Albert Einstein College of Medicine (US)
  • Baylor College of Medicine (US)
  • University of Minnesota (US)
  • University of Alabama at Birmingham (US)
  • University of Washington (US)
  • University of Florida (US)
  • University of California, Los Angeles (US)
  • National Institutes of Health (US)
  • Stanford Medicine (US)
Corresponding author
Snyder, Peter J.
ORCID
Venue
JAMA Internal Medicine
Publisher
American Medical Association (AMA)
Published
2017-04-01
Volume
177
Issue
4
Pages
480
ISSN
2168-6106 (ISSN-L)
DOI
10.1001/jamainternmed.2016.9540
PMC
PMC5433757
OpenAlex
W2593639365
Cited by
239
References
44
Citations by year
2026: 8 · 2025: 24 · 2024: 24 · 2023: 17 · 2022: 31 · 2021: 25 · 2020: 22 · 2019: 33 · 2018: 34 · 2017: 21
FWCI
23.76
Type
journal article
Language
en
Open access
Locations
  • JAMA Internal Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Institutes of Health (5p30ag031679-15, UL1TR001863)
  • National Institute on Aging (U01AG030644, K07AG043587, P30-AG031679, U01AG034661, P30AG028740, P30AG021342)
  • National Institute of Diabetes and Digestive and Kidney Diseases (T32DK060455, P30DK020541)
  • National Center for Advancing Translational Sciences
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
  • Health Sciences › Medicine › Hematology › Erythropoietin and Anemia Treatment
  • Health Sciences › Medicine › Hematology › Iron Metabolism and Disorders
Keywords
testosterone replacement therapy, testosterone gel, anemia, older men, androgen deficiency, hemoglobin, anemia of chronic disease, cancer-related anemia
MeSH terms
Aged, Androgens, Anemia, Double-Blind Method, Drug Administration Routes, Hemoglobins, Humans, Male, Testosterone, Treatment Outcome, Drug Monitoring, Hormone Replacement Therapy

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