Background Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied. Methods Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group. Results A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load. Conclusions In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy.

LGD-4033 was safe, had favorable pharmacokinetic profile, and increased lean body mass even during this short period without change in prostate-specific antigen. Longer randomized trials should evaluate its efficacy in improving physical function and health outcomes in select populations.

Objectives-To determine whether objectively measured physical activity levels are associated with physical function and mobility in older men. Design-Cross-sectional. Setting-Academic research center.Participants-Eighty-two community-dwelling men ≥ 65 years of age with self-reported mobility limitations were divided into a low activity and a high activity group based on the median average daily physical activity counts of the whole sample.Measurements-Physical activity by triaxial accelerometers; physical function and mobility by the Short Physical Performance Battery (SPPB), gait speed, stair climb time, and a lift and lower task; aerobic capacity by maximum oxygen consumption (VO 2 max); and leg press and chest press maximal strength and peak power.Results-Older men with higher compared to lower physical activity levels demonstrated a > 1.4 point higher mean SPPB score and a 0.35 m/s faster walking speed. They also climbed a standard flight of stairs 1.85 sec faster and completed 60% more shelves in a lift and lower task (all p < 0.01). Muscle strength and power measures, however, were not significantly different between the Correspondence: Nathan K. LeBrasseur, PT, PhD, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, Ph/507.266.0727; Fx/ 507.293.3853, lebrasseur.nathan@mayo.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 ContributionsMarina Morie: Data acquisition, analysis and interpretation, manuscript preparation Kieran F. Reid: Data analysis and interpretation, manuscript preparation Renee Miciek: Study concept and design, data acquisition, analysis and interpretation, manuscript preparation Newsha Lajevardi: Data acquisition, manuscript preparation Karen Choong: Data acquisition, interpretation Joanne B. Krasnoff: Data acquisition, analysis and interpretation, manuscript preparation Thomas W. Storer: Study design, data interpretation Roger A. Fielding: Study concept and design, data analysis and interpretation, manuscript preparation Shalender Bhasin: Study concept and design, data interpretation, manuscript preparation Nathan K. LeBrasseur: Study concept and design, data acquisition, analysis and interpretation, manuscript preparation. NIH Public AccessAuthor Manuscript J Am Geriatr Soc. Author manuscript; available in PMC 2011 September 1. NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript low and high activity group. Correlation analyses and multiple linear regression models showed that physical activity is positively associated with all physical function and mobility measures, leg press strength, and VO 2 max.Conclusion-Older men with higher physical activity levels demonstrate better physical function and mobility than less active peers. Moreover, in older men physical activity levels are predictive of performance in measures of physical function and mobility. Future work is n...