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 Journal Article
| Authors: | Hoffman, A. R.; Kuntze, J. E.; Baptista, J.; Baum, H. B. A.; Baumann, G. P.; Biller, B. M. K.; Clark, R. V.; Cook, D.; Inzucchi, S. E.; Kleinberg, D.; Klibanski, A.; Phillips, L. S.; Ridgway, E. C.; Robbins, R. J.; Schlechte, J.; Sharma, M.; Thorner, M. O.; Vance, M. L. |
| Article Title: | 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 |
| Abstract: | 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/k·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. |
| Keywords: | adult; controlled study; aged; middle aged; major clinical study; clinical trial; drug tolerability; placebo; drug efficacy; drug safety; drug withdrawal; side effect; edema; quality of life; controlled clinical trial; randomized controlled trial; estrogen; dose-response relationship, drug; growth hormone; growth hormone deficiency; hypothalamus hypophysis system; arthralgia; cardiovascular risk; multicenter study; arthritis; recombinant proteins; human growth hormone; insulin; anthropometry; cholesterol; glucose; low density lipoprotein cholesterol; lipids; somatomedin c; body composition; double blind procedure; double-blind method; insulin-like growth factor i; placebos; hormone substitution; muscle, skeletal; metabolism, inborn errors; carpal tunnel syndrome; glucose metabolism; impaired glucose tolerance; graves disease; hormone action; muscle strength; humans; human; male; female; priority journal; article; endurance; physical endurance |
| Journal Title: | Journal of Clinical Endocrinology and Metabolism |
| Volume: | 89 |
| Issue: | 5 |
| ISSN: | 0021-972X |
| Publisher: | Oxford University Press |
| Date Published: | 2004-05-01 |
| Start Page: | 2048 |
| End Page: | 2056 |
| Language: | English |
| DOI: | 10.1210/jc.2003-030346 |
| PROVIDER: | scopus |
| PUBMED: | 15126520 |
| DOI/URL: | |
| Notes: | J. Clin. Endocrinol. Metab. -- Cited By (since 1996):95 -- Export Date: 16 June 2014 -- CODEN: JCEMA -- Source: Scopus |
