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The Journal of Clinical Endocrinology & Metabolism Vol. 89, No. 5 2048-2056
Copyright © 2004 by The Endocrine Society

Growth Hormone (GH) Replacement Therapy in Adult-Onset GH Deficiency: Effects on Body Composition in Men and Women in a Double-Blind, Randomized, Placebo-Controlled Trial

Andrew R. Hoffman, Joyce E. Kuntze, Joyce Baptista, Howard B. A. Baum, Gerhard P. Baumann, Beverly M. K. Biller, Richard V. Clark, David Cook, Silvio E. Inzucchi, David Kleinberg, Anne Klibanski, Lawrence S. Phillips, E. Chester Ridgway, Richard J. Robbins, Janet Schlechte, Meeta Sharma, Michael O. Thorner and Mary Lee Vance

Veterans Affairs Palo Alto Health Care System and Stanford University (A.R.H.), Palo Alto, California 94304; Medical Affairs (J.E.K., J.B.), Genentech, Inc., South San Francisco, California 94080; Harvard Medical School and Massachusetts General Hospital (H.B.A.B., B.M.K.B., A.K.), Boston, Massachusetts 02114; Duke University Medical Center (R.V.C.), Durham, North Carolina, 27710; Northwestern University Medical School (G.P.B.), Chicago, Illinois 60611; Oregon Health Sciences University (D.C.), Portland, Oregon 97201; Yale School of Medicine (S.E.I.), New Haven, Connecticut 06520; New York University Medical Center and Veterans Affairs Medical Center (D.K.), New York, New York 10010; Emory University School of Medicine (L.S.P.), Atlanta, Georgia 30322; University of Colorado Health Science Center (E.C.R.), Denver, Colorado 80220; Memorial Sloan-Kettering Cancer Center (R.J.R.), New York, New York 10021; University of Iowa (J.S.), Iowa City, Iowa 52242; George Washington University School of Medicine and Health Science (M.S.), Washington, D.C. 20037; and University of Virginia Health Science Center (M.O.T., M.L.V.), Charlottesville, Virginia 22908

Address all correspondence and requests for reprints to: Andrew R. Hoffman, M.D., Medical Service, VA Palo Alto Health Care System, 3801 Miranda Avenue, Palo Alto, California 94304. E-mail: arhoffman{at}stanford.edu.

Adult GH deficiency (AGHD) is characterized by an altered body composition, an atherogenic lipid profile, decreased exercise capacity, and diminished quality of life. We performed a randomized, double-blind, placebo-controlled, multicenter study in 166 subjects with AGHD to assess the effects of GH on these outcomes. GH was initiated at 0.0125 mg/kg·d, increased to 0.025 mg/kg·d as tolerated, or decreased to 0.00625 mg/kg·d for 12 months. Primary measures of efficacy included body composition, strength and endurance, and quality of life. Additional parameters included serum IGF-I concentrations, serum lipids, and bone mineral density.

After 12 months, 79% of subjects remained on GH 0.0125 mg/kg·d, whereas 21% received 0.00625 mg/kg·d. GH-treated men and women demonstrated significant decreases in total body and trunk fat and increases in lean body mass over baseline. In GH-treated men, mean IGF-I SD scores exceeded age-adjusted normal ranges, whereas similar doses produced a smaller response in women. GH treatment was associated with significant improvements in total cholesterol and low-density lipoprotein (P < 0.05 for all). No significant treatment effects were observed in strength and endurance, quality of life, or bone mineral density. GH treatment was generally well tolerated. Subjects with AGHD should receive individualized GH therapy to maintain IGF-I between the mean value and +2 SD and improve body composition and cardiovascular risk factors.

This work was supported by Genentech, Inc.

Abbreviations: AGHD, Adult GH deficiency; BMD, bone mineral density; BMI, body mass index; DXA, dual-energy x-ray absorptiometry; ERT, estrogen replacement therapy; HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; LDL, low-density lipoprotein; SDS, SD score.




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