Growth Hormone and Sex Steroid Administration in Healthy Aged Women and Men: A Randomized Controlled Trial

• Published in: JAMA : the journal of the American Medical Association 2002-11, Vol.288 (18), p.2282-2292
• Main Authors: Blackman, Marc R, Sorkin, John D, Münzer, Thomas, Bellantoni, Michele F, Busby-Whitehead, Jan, Stevens, Thomas E, Jayme, Jocelyn, O'Connor, Kieran G, Christmas, Colleen, Tobin, Jordan D, Stewart, Kerry J, Cottrell, Ernest, St. Clair, Carol, Pabst, Katharine M, Harman, S. Mitchell
• Format: Article
• Language: English
• Subjects: Adults; Aged; Aged, 80 and over; Biological and medical sciences; Blood Glucose - drug effects; Body Composition - drug effects; Diabetes Mellitus; Double-Blind Method; Estradiol - blood; Estradiol - pharmacology; Female; Hematocrit; Hormone Replacement Therapy - adverse effects; Hormones; Hormones. Endocrine system; Human Growth Hormone - pharmacology; Humans; Insulin-Like Growth Factor I - metabolism; Male; Medical sciences; Medroxyprogesterone Acetate - blood; Medroxyprogesterone Acetate - pharmacology; Muscle, Skeletal - drug effects; Muscular system; Oxygen Consumption - drug effects; Pharmacology. Drug treatments; Physical Endurance - drug effects; Physical growth; Steroids; Steroids - blood; Steroids - pharmacology; Testosterone - analogs & derivatives; Testosterone - blood; Testosterone - pharmacology
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.288.18.2282

CONTEXT Hormone administration to elderly individuals can increase lean body mass (LBM) and decrease fat, but interactive effects of growth hormone (GH) and sex steroids and their influence on strength and endurance are unknown. OBJECTIVE To evaluate the effects of recombinant human GH and/or sex steroids on body composition, strength, endurance, and adverse outcomes in aged persons. DESIGN, SETTING, AND PARTICIPANTS A 26-week randomized, double-blind, placebo-controlled parallel-group trial in healthy, ambulatory, community-dwelling US women (n = 57) and men (n = 74) aged 65 to 88 years recruited between June 1992 and July 1998. INTERVENTIONS Participants were randomized to receive GH (starting dose, 30 µg/kg, reduced to 20 µg/kg, subcutaneously 3 times/wk) + sex steroids (women: transdermal estradiol, 100 µg/d, plus oral medroxyprogesterone acetate, 10 mg/d, during the last 10 days of each 28-day cycle [HRT]; men: testosterone enanthate, biweekly intramuscular injections of 100 mg) (n = 35); GH + placebo sex steroid (n = 30); sex steroid + placebo GH (n = 35); or placebo GH + placebo sex steroid (n = 31) in a 2 × 2 factorial design. MAIN OUTCOME MEASURES Lean body mass, fat mass, muscle strength, maximum oxygen uptake (O2max) during treadmill test, and adverse effects. RESULTS In women, LBM increased by 0.4 kg with placebo, 1.2 kg with HRT (P = .09), 1.0 kg with GH (P = .001), and 2.1 kg with GH + HRT (P