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Effects of an Oral Growth Hormone Secretagogue in Older Adults

Duke University School of Medicine and Geriatric Research Education and Clinical Center (GRECC), Durham Veterans Affairs (VA) Medical Center (H.K.W., K.L., M.C.M.), Durham, North Carolina 27710; Pfizer Global Research and Development (C.D.P.), Groton, Connecticut 06340; Endocrine Clinical Research (W.L.), Eli Lilly and Co., Indianapolis, Indiana 46285; Brown University Medical School (D.M.), Providence, Rhode Island 02912; Novartis (A.T.), Cambridge, Massachusetts 02139; GRECC, Central Arkansas Veterans Affairs (VA) Healthcare System, and University of Arkansas for Medical Sciences (J.Y.W.), Little Rock, Arkansas 72205; VA Palo Alto Health Care System and Stanford University (A.R.H.), Palo Alto, California 94304; The Johns Hopkins University School of Medicine (R.S.), Baltimore, Maryland 21205; Radiant Research and the Regional Osteoporosis Center (M.P.E.), Stuart, Florida 34996; Washington DC VA Medical Center (M.R.B.), Washington, D.C. 20422; and VA Puget Sound Health Care System and University of Washington School of Medicine (G.R.M.), Seattle and Tacoma, Washington 98493

Address all correspondence and requests for reprints to: Heidi K. White, M.D., M.H.S., Duke University School of Medicine, Box 3003, Durham, North Carolina 27710. E-mail: White031{at}mc.duke.edu.

Context: GH secretion declines with age, possibly contributing to reduced muscle mass, strength, and function. GH secretagogues (GHS) may increase muscle mass and physical performance.

Objectives/Design: We conducted a randomized, double-masked, placebo-controlled, multicenter study to investigate the hormonal, body composition, and physical performance effects and the safety of the orally active GHS capromorelin in older adults with mild functional limitation.

Intervention/Participants: A total of 395 men and women aged 65–84 yr were randomized for an intended 2 yr of treatment to four dosing groups (10 mg three times/week, 3 mg twice a day, 10 mg each night, and 10 mg twice a day) or placebo. Although the study was terminated early according to predetermined treatment effect criteria, 315 subjects completed 6 months of treatment, and 284 completed 12 months.

Results: A sustained dose-related rise in IGF-I concentrations occurred in all active treatment groups. Each capromorelin dose prompted a rise in peak nocturnal GH, which was greatest with the least frequent dosing. At 6 months, body weight increased 1.4 kg in subjects receiving capromorelin and decreased 0.2 kg in those receiving placebo (P = 0.006). Lean body mass increased 1.4 vs. 0.3 kg (P = 0.001), and tandem walk improved by 0.9 sec (P = 0.02) in the pooled treatment vs. placebo groups. By 12 months, stair climb also improved (P = 0.04). Adverse events included fatigue, insomnia, and small increases in fasting glucose, glycosylated hemoglobin, and indices of insulin resistance.

Conclusions: In healthy older adults at risk for functional decline, administration of the oral GHS capromorelin may improve body composition and physical function.