Effects of Testosterone on Muscle Strength, Physical
Function, Body Composition, and Quality of Life in
Intermediate-Frail and Frail Elderly Men: A
Randomized, Double-Blind, Placebo-Controlled Study
Upendram Srinivas-Shankar, Stephen A. Roberts, Martin J. Connolly,
Matthew D. L. O’ Connell, Judith E. Adams, Jackie A. Oldham,
and Frederick C. W. Wu
Department of Medicine and Endocrinology (U.S.-S., M.D.L.O., F.C.W.W.), University of Manchester
Manchester Royal Infirmary; Health Methodology Research Group (S.A.R.); Clinical Radiology, Imaging
Science, and Biomedical Engineering (J.E.A.); and Centre for Rehabilitation Science (J.A.O.), University of
Manchester, Manchester, United Kingdom M13 9WL; and Freemasons’ Department of Geriatric
Medicine (M.J.C.), University of Auckland, 1142 Auckland, New Zealand
Context: Physical frailty is associated with reduced muscle strength, impaired physical function,and
quality of life. Testosterone (T) increases muscle mass and strength in hypogonadal patients. It is
unclear whether T has similar effects in intermediate-frail and frail elderly men with low to borderline-
low T.
Objective: Our objective was to determine the effects of 6 months T treatment in intermediate-frail
and frail elderly men, on muscle mass and strength, physical function, and quality of life.
Design and Setting: We conducted a randomized, double-blind, placebo-controlled, parallelgroup,
single-center study.
Participants: Participants were community-dwelling intermediate-frail and frail elderly men at
least 65 yr of age with a total T at or below 12 nmol/liter or free T at or below 250 pmol/liter.
Methods: Two hundred seventy-four participants were randomized to transdermal T (50 mg/d) or
placebo gel for 6 months. Outcome measures included muscle strength, lean and fat mass, physical
function, and self-reported quality of life.
Results: Isometric knee extension peak torque improved in the T group (vs. placebo at 6 months),
adjusted difference was 8.6 (95% confidence interval, 1.3–16.0; P _ 0.02) Newton-meters. Lean
body mass increased and fat mass decreased significantly in the T group by 1.08 _ 1.8 and 0.9 _
1.6 kg, respectively. Physical function improved among older and frailer men. Somatic and sexual
symptom scores decreased with T treatment; adjusted difference was _1.2 (_2.4 to _0.04) and
_1.3 (_2.5 to _0.2), respectively.
Conclusions: T treatment in intermediate-frail and frail elderly men with low to borderline-low T
for 6 months may prevent age-associated loss of lower limb muscle strength and improve body
composition, quality of life, and physical function. Further investigations are warranted to extend
these results. (J Clin Endocrinol Metab 95: 0000–0000, 2010)
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