Objectives-To investigate the effects of testosterone supplementation on bone, body composition, muscle, physical function, and safety in older men.Design, Setting, Participants-Double-blind, randomized, placebo-controlled trial was done at a major medical institution of 131 men (mean 77.1 ± 7.6 yr) with low testosterone level, history of fracture or bone mineral density (BMD) T-score of < −2.0 AND frailty.Intervention-Participants received 5 mg/d testosterone (AndroGel™) or placebo for 12-24 months; all received calcium (1500 mg/d diet and supplement) and cholecalciferol (1000 IU/d).Measurements-BMD of hip, lumbar spine, and mid-radius, body composition, sex and calcium regulating hormones, bone turnover markers, strength, physical performance, and safety parameters.Results-Ninety -nine men (75.6%) completed 12 months and 62 men (47.3%) completed end therapy (mean 23 months; range 16-24 months for 62 men in this group). Study adherence was 54%, 40% of subjects maintaining 70% or greater adherence. Testosterone and bioavailable testosterone levels at 12 months were 583 ng/dL and 157 ng/dL in the treatment group. BMD on testosterone increased 1.38% at the femoral neck, 3.25% at the lumbar spine (p=.005) and decreased by 1.29% at the mid-radius (p=.0008). There was an increase in lean mass and decrease in fat mass in the testosterone group, but no differences in strength or physical performance. Finally, there were no differences in safety parameters.Correspondence to: Anne Kenny, MD, Center on Aging, MC-5215, University of Connecticut Health Center, Farmington, CT 06030-5215, kenny@uchc.edu.
Conflict of Interest:The editor in chief has reviewed the conflict of interest checklist provided by the authors and has determined that the authors have no financial or any other kind of personal conflicts with this paper.Author Contributions: Dr. Kenny was responsible for intellectual content of the paper by conception and design, obtaining funding, acquisition of data and analysis and interpretation of results, drafting and revision of the manuscript, administrative, technical and material support, and supervision. Ms. Kleppinger was responsible for analysis and interpretation of results, drafting and revision of the manuscript and technical support. Ms. Annis was responsible for acquisition of data, drafting and revision of manuscript and technical support. Dr. Rathier was responsible for intellectual content of the paper by analysis and interpretation of the results, drafting and revision of the manuscript. Dr. Bowner was responsible for intellectual content of the paper by analysis and interpretation of the results, drafting and revision of the manuscript. Dr. Judge was responsible for intellectual content of the paper by analysis and interpretation of the results, drafting and revision of the manuscript. Dr. McGee was responsible for acquisition of data, analysis and interpretation of results, and drafting and revision of manuscript. All authors give final approval to the manuscript submitted. Conclusion-Older,...