Effect of Testosterone Supplementation on Functional Mobility, Cognition, and Other Parameters in Older Men : A Randomized Controlled Trial

• Published in: JAMA : the journal of the American Medical Association Vol. 299; no. 1; pp. 39 - 52
• Main Authors: Emmelot-Vonk, Marielle H, Verhaar, Harald J. J, Nakhai Pour, Hamid R, Aleman, André, Lock, Tycho M. T. W, Bosch, J. L. H. Ruud, Grobbee, Diederick E, van der Schouw, Yvonne T
• Format: Journal Article
• Language: English
• Published: Chicago, IL American Medical Association 02-01-2008
• Subjects: Activities of Daily Living; Aged; Aging - drug effects; Aging - physiology; Biological and medical sciences; Blood Glucose; Body Composition - drug effects; Bone density; Bone Density - drug effects; Cholesterol; Cognition - drug effects; Double-Blind Method; General aspects; Humans; Insulin Resistance; Lipids - blood; Male; Medical sciences; Mens health; Metabolic Syndrome; Middle Aged; Muscle Strength; Older people; Quality of Life; Testosterone; Testosterone - administration & dosage; Testosterone - analogs & derivatives; Testosterone - blood; Testosterone - pharmacology; Human; Androgen; Mobility; Male; Cognition; Medicine; Testosterone; Randomization; Clinical trial; Testicular hormone; Supplementation; Sex steroid hormone; Elderly
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.2007.51

CONTEXT
Serum testosterone levels decline significantly with aging.
Testosterone supplementation to older men might beneficially affect the aging processes.
OBJECTIVE To investigate the effect of testosterone supplementation on functional mobility, cognitive function, bone mineral density, body composition, plasma lipids, quality of life, and safety parameters in older men with low normal testosterone levels. DESIGN, SETTING, AND PARTICIPANTS Double-blind, randomized, placebo-controlled trial of 237 healthy men between the ages of 60 and 80 years with a testosterone level lower than 13.7 nmol/L conducted from January 2004 to April 2005 at a university medical center in the Netherlands. INTERVENTION Participants were randomly assigned to receive 80 mg of testosterone undecenoate or a matching placebo twice daily for 6 months. MAIN OUTCOME MEASURES
Functional mobility (Stanford Health Assessment Questionnaire,
timed get up and go test, isometric handgrip strength, isometric leg extensor strength), cognitive function (8 different cognitive instruments),
bone mineral density of the hip and lumbar spine (dual-energy x-ray absorptiometry scanning), body composition (total body dual-energy x-ray absorptiometry and abdominal ultrasound of fat mass), metabolic risk factors (fasting plasma lipids, glucose, and insulin), quality of life (Short-Form Health 36 Survey and the Questions on Life Satisfaction Modules), and safety parameters (serum prostate-specific antigen level,
ultrasonographic prostate volume, International Prostate Symptom score,
serum levels of creatinine, aspartate aminotransferase, alanine aminotransferase, γ-glutamyltransferase,
hemoglobin, and hematocrit).
RESULTS
A total of 207 men completed the study. During the study, lean body mass increased and fat mass decreased in the testosterone group compared with the placebo group but these factors were not accompanied by an increase of functional mobility or muscle strength. Cognitive function and bone mineral density did not change. Insulin sensitivity improved but high-density lipoprotein cholesterol decreased; by the end of the study, 47.8% in the testosterone group vs 35.5% in the placebo group had the metabolic syndrome (P = .07).
Quality-of-life measures were no different except for one hormone-related quality-of-life measure that improved. No negative effects on prostate safety were detected.
CONCLUSION Testosterone supplementation during 6 months to older men with a low normal testosterone concentration did not affect functional status or cognition but increased lean body mass and had mixed metabolic effects. TRIAL REGISTRATION
isrctn.org Identifier: ISRCTN23688581