The Effects of Growth Hormone and/or Testosterone in Healthy Elderly Men: A Randomized Controlled Trial

Context: Declines in GH and testosterone (Te) secretion may contribute to the detrimental aging changes of elderly men. Objective: To assess the effects of near-physiological GH with/without Te administration on lean body mass, total body fat, midthigh muscle cross-section area, muscle strength, aerobic capacity, condition-specific quality of life (Age-Related Hormone Deficiency-Dependent Quality of Life questionnaire), and generic health status (36Item Short-Form Health Survey) of older men. Design, Settings, and Participants: A 6-month, randomized, double-blind, placebo-controlled trial was performed on 80 healthy, community-dwelling, older men (age, 65–80 yr). Interventions: Participants were randomized to receive 1) placebo GH or placebo Te, 2) recombinant human GH (rhGH) and placebo Te (GH), 3) Te and placebo rhGH (Te), or 4) rhGH and Te (GHTe). GH doses were titrated over 8 wk to produce IGF-I levels in the upper half of the age-specific reference range. A fixed dose of Te (5 mg) was given by transdermal patches. Results:LeanbodymassincreasedwithGHTe(P0.008)andGH(P 0.004), compared with placebo. Total body fat decreased with GHTe only (P0.02). Midthigh muscle (P0.006) and aerobic capacity (P0.001) increased only after GHTe. Muscle strength changes were variable; one of six measures significantly increased with GHTe. Significant treatment group by time interactions indicated an improved Age-Related Hormone Deficiency-Dependent Quality of Life questionnaire score (P 0.007)intheGHandGHTegroups.BodilypainincreasedwithGHalone, asdeterminedbytheShort-FormHealthSurvey(P0.003).Therewere no major adverse effects. Conclusion: Coadministration of low dose GH with Te resulted in beneficial changes being observed more often than with either GH or Te alone. (J Clin Endocrinol Metab 91: 477–484, 2006)