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• W2034440415 abstract "GHD. We previously published results of wide-range dose response (25–100mcg/kg/day) GH therapy (GHT) for 2 yrs in pre-pubertal children with GHD. As a follow up to this study, we investigated the longer-term effects of this range of GH doses on growth and pubertal development in these children, since there are still some concerns that higher doses of GH may accelerate pubertal development. 111 pre-pubertal children (75M/36F, mean±SD age 7.8±2.8 yrs, height standard deviation score [HSDS] −3.0±0.9) with GHD were randomized to receive low (L), medium (M), or high (H) (25, 50, 100mcg/kg/day, respectively) dose GH for up to 4 yrs (median duration 42 months). Fifty-two patients completed 48 months of treatment. The M and H dose groups reached HSDS of +0.03 and +0.27 at 48 months, whereas the L dose group reached a HSDS of −1.46. The mean changes in HSDS (DHSDS) at 48 months for the L, M, and H groups were 1.91, 3.05, and 3.13, respectively. M and H dose group DHSDS were significantly greater than the L dose group (p < 0.001 for both), and there was no significant difference between the M and H dose groups. There was no difference among the dose groups in initiation of puberty over time. The percentages of subjects remaining pre-pubertal were similar among the 3 groups. No significant difference in body mass index was observed among the 3 groups at 48 months. For patients (n = 29) with bone age (BA) measurements at 36 months, mean BA/chronological age ratio was 0.79 (n =12), 0.95 (n =9), and 0.96 (n =8) for the L, M, and H dose groups. In conclusion, medium and high dose GHT over 4 years in pre-pubertal children with GHD resulted in a HSDS at the reference population mean, and was significantly greater than that observed in the low dose group. Importantly, no difference in the percentage of children entering puberty was observed among the dose groups. Although it is important to adjust GH dose based on individual clinical response, as there was no apparent difference in DHSDS achieved between the medium and high dose groups over long-term therapy, a steady weight-based GH dose of 100 mcg/kg/d is unlikely to be required or appropriate for pre-pubertal children with GHD." @default.
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• W2034440415 date "2010-01-01" @default.
• W2034440415 modified "2023-09-26" @default.
• W2034440415 title "OR11,65 Randomized controlled trial on the effects of growth hormone therapy and nutritional supplementation in boys with constitutional growth delay" @default.
• W2034440415 doi "https://doi.org/10.1016/s1096-6374(10)70081-2" @default.
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