Clinical meaningfulness of the changes in muscle performance and physical
function associated with testosterone administration in older men with mobility
limitation.
Author(s): Travison TG, Basaria S, Storer TW, Jette AM, Miciek R, Farwell WR, Choong K,
Lakshman K, Mazer NA, Coviello AD, Knapp PE, Ulloor J, Zhang A, Brooks B, Nguyen
AH, Eder R, LeBrasseur N, Elmi A, Appleman E, Hede-Brierley L, Bhasin G, Bhatia
A, Lazzari A, Davis S, Ni P, Collins L, Bhasin S.
Affiliation(s): Section of Endocrinology, Diabetes, and Nutrition, Boston University School of
Medicine and Boston Medical Center, 670 Albany Street, Boston, MA 02118, USA.
Publication date & source: 2011, J Gerontol A Biol Sci Med Sci. , 66(10):1090-9
CONTEXT: Testosterone in Older Men with Mobility Limitations Trial determined the
effects of testosterone on muscle performance and physical function in older men
with mobility limitation. Trial's Data and Safety Monitoring Board recommended
enrollment cessation due to increased frequency of adverse events in testosterone
arm. The changes in muscle performance and physical function were evaluated in
relation to participant's perception of change.
METHODS: Men aged 65 years and older, with mobility limitation, total
testosterone 100-350 ng/dL, or free testosterone less than 50 pg/mL, were
randomized to placebo or 10 g testosterone gel daily for 6 months. Primary
outcome was leg-press strength. Secondary outcomes included chest-press strength,
stair-climb, 40-m walk, muscle mass, physical activity, self-reported function,
and fatigue. Proportions of participants exceeding minimally important difference
in study arms were compared.
RESULTS: Of 209 randomized participants, 165 had follow-up efficacy measures.
Mean (SD) age was 74 (5.4) years and short physical performance battery score 7.7
(1.4). Testosterone arm exhibited greater improvements in leg-press strength,
chest-press strength and power, and loaded stair-climb than placebo. Compared
with placebo, significantly greater proportion of men receiving testosterone
improved their leg-press and chest-press strengths (43% vs 18%, p = .01) and
stair-climbing power (28% vs 10%, p = .03) more than minimally important
difference. Increases in leg-press strength and stair-climbing power were
associated with changes in testosterone levels and muscle mass. Physical
activity, walking speed, self-reported function, and fatigue did not change.
CONCLUSIONS: Testosterone administration in older men with mobility limitation
was associated with patient-important improvements in muscle strength and
stair-climbing power. Improvements in muscle strength and only some physical
function measures should be weighed against the risk of adverse events in this
population.
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