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Continued Growth Hormone (GH) Treatment after Final Height Is Necessary to Complete Somatic Development in Childhood-Onset GH-Deficient Patients

Christie Hospital (S.M.S.), Manchester M20 4BX, United Kingdom; PSI (E.S.), St. Petersburg 19119, Russia; Eli Lilly & Co. (M.C., J.J.C.), Indianapolis, Indiana 46285; Children’s Hospital (M.P.), 04011 Kosice, Slovakia; Department of Pediatrics, Third Faculty of Medicine, Charles University (J.L.), CZ-10081 Prague, Czech Republic; Lilly Research (C.J.C.), Windlesham GU20 6PH, United Kingdom; Lilly Research (W.F.B.), Bad Homburg D-61350, Germany; and Lilly Research (A.F.A.), 50019 Sesto Fiorentino, Italy

Address all correspondence and requests for reprints to: Dr. Stephen M. Shalet, Department of Endocrinology, Christie Hospital, National Health Service Trust, Wilmslow Road, Manchester, United Kingdom M20 4BX. E-mail: stephen.m.shalet{at}man.ac.uk.

Lean body mass (LBM), fat mass (FM), and total bone mineral content are significantly reduced in adult GHD subjects who had received pediatric GH. To test the hypothesis that continued GH therapy after final height is necessary to attain adult body composition, we performed a prospective, multinational, randomized, controlled, 2-yr study in patients who completed pediatric GH treatment at final height. Patients were randomized to GH at 25.0 µg/kg·d (pediatric dose; n = 58) or 12.5 µg/kg·d (adult dose; n = 59) or no GH treatment (control; n = 32). LBM and FM were measured by dual energy x-ray absorptiometry and were centrally evaluated. IGF-I, IGF-binding protein-3, and lipid concentrations were also measured centrally. During the 2 yr, GH-treated patients gained a significant amount of LBM compared with controls (P < 0.001), but the change with the higher pediatric dose (14.2 ± 11.7%) was not different from that seen with the lower adult dose (12.7 ± 9.4%; P = 0.970). Similarly, the decrease in FM was significantly (P = 0.029) influenced by treatment, but with no dose effect (adult dose, –7.1 ± 22.8%; pediatric dose, –6.0 ± 26.6%; P = 0.950). When the GH treatment effect was analyzed by gender, males gained 15.6 ± 9.8% and 14.3 ± 11.7% LBM (P = 0.711) and lost 12.4 ± 22.2% and 11.0 ± 27.1% FM (P = 0.921) with the low and high doses, respectively. Females gained 8.3 ± 7.3% and 12.5 ± 12.8% LBM with the two doses (P = 0.630), but increased their FM by 3.5 ± 16.2% with the lower dose and lost only 1.2 ± 23.2% FM with the higher dose (P = 0.325). A similar pattern was seen in IGF-I SD score; the 2-yr GH dose response was significantly higher with the pediatric than with the adult dose in females (P = 0.008), but not males (P = 0.790). The divergent pattern of change in LBM and FM in males and females is consistent with normal developmental sexual dimorphism and indicates that GH-dependent progress to target body composition continues after the age at which GH treatment is usually terminated. Dose requirements may have to be adjusted by gender, with females requiring a higher dose than males.

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