Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels, low bone mass, and physical frailty.
OBJECTIVE
To investigate the effects of testosterone supplementation on bone, body composition, muscle, physical function, and safety in older men.


METHODS
Double-blind, randomized, placebo-controlled trial.


METHODS
A major medical institution.


METHODS
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.


METHODS
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).


METHODS
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.


CONCLUSIONS
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.
Kenny
Anne M
AM
Center on Aging, MC-5215, University of Connecticut Health Center, Farmington, CT 06030, USA. kenny@uchc.edu
Kleppinger
Alison
A
Annis
Kristen
K
Rathier
Margaret
M
Browner
Bruce
B
Judge
James O
JO
McGee
Daniel
D
D000279:Administration, Cutaneous; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D001682:Biological Availability; D001823:Body Composition / Q000502:physiology; D015519:Bone Density / Q000502:physiology; D001842:Bone and Bones / Q000187:drug effects* / Q000502:physiology; D002762:Cholecalciferol / Q000008:administration & dosage; D004311:Double-Blind Method; D016330:Frail Elderly; D015577:Geriatric Assessment; D006801:Humans; D008297:Male; D008875:Middle Aged; D009132:Muscles / Q000187:drug effects* / Q000502:physiology; D010919:Placebos; D013739:Testosterone / Q000008:administration & dosage* / Q000378:metabolism
D010919:Placebos; D002762:Cholecalciferol; D013739:Testosterone