TY - JOUR
T1 - Clinical meaningfulness of the changes in muscle performance and physical function associated with testosterone administration in older men with mobility limitation
AU - Travison, Thomas G.
AU - Basaria, Shehzad
AU - Storer, Thomas W.
AU - Jette, Alan M.
AU - Miciek, Renee
AU - Farwell, Wildon R.
AU - Choong, Karen
AU - Lakshman, Kishore
AU - Mazer, Norman A.
AU - Coviello, Andrea D.
AU - Knapp, Philip E.
AU - Ulloor, Jagadish
AU - Zhang, Anqi
AU - Brooks, Brad
AU - Nguyen, Ahn Hoa
AU - Eder, Richard
AU - Lebrasseur, Nathan
AU - Elmi, Ayan
AU - Appleman, Erica
AU - Hede-Brierley, Leife
AU - Bhasin, Geeta
AU - Bhatia, Ashmeet
AU - Lazzari, Antonio
AU - Davis, Samuel
AU - Ni, Pengsheng
AU - Collins, Lauren
AU - Bhasin, Shalender
N1 - Funding Information:
This study was supported primarily by a grant from the National Institutes on Aging administered under a cooperative agreement (1UO1AG14369). Additional support was provided by Boston Claude D. Pepper Older Americans Independence Center grant (5P30AG031679) and a BU Clinical and Translational Science Institute grant (1UL1RR025771). Testosterone and placebo gel for the study were provided by Auxilium Pharmaceuticals, Inc., Norristown, PA. The MID Substudy was supported in part by a research grant from Merck and Co. to Boston University. A part of the work was supported by the resources and facilities of the VA Boston Healthcare System.
PY - 2011/10
Y1 - 2011/10
N2 - 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.
AB - 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.
KW - Function promoting therapies
KW - Minimally important difference
KW - Mobility limitation
KW - Older men
KW - Testosterone
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U2 - 10.1093/gerona/glr100
DO - 10.1093/gerona/glr100
M3 - Article
C2 - 21697501
AN - SCOPUS:80052912002
SN - 1079-5006
VL - 66 A
SP - 1090
EP - 1099
JO - Journals of Gerontology - Series A Biological Sciences and Medical Sciences
JF - Journals of Gerontology - Series A Biological Sciences and Medical Sciences
IS - 10
ER -