Effects of Transdermal Testosterone on Bone and Muscle in Older Men with Low Bioavailable Testosterone Levels, Low Bone Mass, and Physical Frailty

• Published in: Journal of the American Geriatrics Society (JAGS) Vol. 58; no. 6; pp. 1134 - 1143
• Main Authors: Kenny, Anne M., Kleppinger, Alison, Annis, Kristen, Rathier, Margaret, Browner, Bruce, Judge, James O., McGee, Daniel
• Format: Journal Article
• Language: English
• Published: Malden, USA Blackwell Publishing Inc 01.06.2010; Wiley-Blackwell; Wiley Subscription Services, Inc
• Subjects: Administration, Cutaneous; Aged; Aged, 80 and over; Analysis of Variance; Biological and medical sciences; Biological Availability; Body Composition - physiology; Bone and Bones - drug effects; Bone and Bones - physiology; Bone density; Bone Density - physiology; Cholecalciferol - administration & dosage; Clinical trials; Diseases of the osteoarticular system; Double-Blind Method; Effects; Frail Elderly; frailty; General aspects; Geriatric Assessment; Humans; hypogonadism; Male; Medical sciences; Men; Middle Aged; Miscellaneous; Muscles - drug effects; Muscles - physiology; Muscular system; Older people; osteoporosis; Osteoporosis. Osteomalacia. Paget disease; Placebos; Public health. Hygiene; Public health. Hygiene-occupational medicine; Testosterone; Testosterone - administration & dosage; Testosterone - metabolism; Transdermal medication; Human; Delivery system; Transdermal system; Androgen; Diseases of the osteoarticular system; Male; Hypogonadism; Genital diseases; Percutaneous route; Osteoarticular system; Osteoporosis; Testosterone; frailty; Gerontology; Bone mass; Low; Frailty in elderly; Dosage form; Muscle; Testicular hormone; Bone; Sex steroid hormone; Elderly; Geriatrics
• ISSN: 0002-8614; 1532-5415; 1532-5415
• DOI: 10.1111/j.1532-5415.2010.02865.x

OBJECTIVES: To investigate the effects of testosterone supplementation on bone, body composition, muscle, physical function, and safety in older men. DESIGN: Double‐blind, randomized, placebo‐controlled trial. SETTING: A major medical institution. PARTICIPANTS: One hundred thirty‐one men (mean age 77.1 ± 7.6) with low testosterone, history of fracture, or bone mineral density (BMD) T‐score less than −2.0 and frailty. INTERVENTION: Participants received 5 mg/d of testosterone or placebo for 12 to 24 months; all received calcium (1500 mg/d diet and supplement) and cholecalciferol (1,000 IU/d). MEASUREMENTS: BMD of hip, lumbar spine, and mid‐radius; body composition; sex hormones, calcium‐regulating hormones; bone turnover markers; strength; physical performance; and safety parameters. RESULTS: Ninety‐nine men (75.6%) completed 12 months, and 62 (47.3%) completed end therapy (mean 23 months; range 16–24 months for 62 who completed therapy). Study adherence was 54%, with 40% of subjects maintaining 70% or greater adherence. Testosterone and bioavailable testosterone levels at 12 months were 583 ng/dL and 157 ng/dL, respectively, in the treatment group. BMD on testosterone increased 1.4% at the femoral neck and 3.2% at the lumbar spine (P=.005) and decreased 1.3% at the mid‐radius (P<.001). There was an increase in lean mass and a decrease in fat mass in the testosterone group but no differences in strength or physical performance. There were no differences in safety parameters. CONCLUSION: Older, frail men receiving testosterone replacement increased testosterone levels and had favorable changes in body composition, modest changes in axial BMD, and no substantial changes in physical function.