Efficacy of Short-Term Growth Hormone Treatment in Prepubertal Children with Idiopathic Short Stature.
- Author:
Ho Seong KIM
1
;
Sei Won YANG
;
Han Wook YOO
;
Byung Kyu SUH
;
Cheol Woo KO
;
Woo Yeong CHUNG
;
Kee Hyoung LEE
;
Jin Soon HWANG
;
Hyi Jeong JI
;
Hyunji AHN
;
Duk Hee KIM
Author Information
- Publication Type:Original Article ; Clinical Trial ; Multicenter Study
- Keywords: Treatment outcome; safety; growth hormone; child; short stature; idiopathic
- MeSH: Child; Female; Growth Disorders/blood/*drug therapy; Growth Hormone/*therapeutic use; Humans; Insulin-Like Growth Factor Binding Protein 3/blood; Insulin-Like Growth Factor I/metabolism; Male; Treatment Outcome
- From:Yonsei Medical Journal 2014;55(1):53-60
- CountryRepublic of Korea
- Language:English
- Abstract: PURPOSE: It has been reported that daily recombinant human growth hormone (GH) treatment showed beneficial effects on growth in prepubertal children with idiopathic short stature (ISS). The present study aimed to validate the GH (Eutropin(R)) effect on growth promotion and safety after short-term GH treatment. MATERIALS AND METHODS: This study was an open-label, multicenter, interventional study conducted at nine university hospitals in Korea between 2008 and 2009. Thirty six prepubertal children with ISS were enrolled in this study to receive 6-month GH treatment. Yearly growth rate, height standard deviation score (SDS), and adverse events were investigated during treatment. RESULTS: After 26 weeks of GH treatment, the height velocity significantly increased by 6.36+/-3.36 cm/year (p<0.001). The lower end of one-sided 95% confidence interval was 5.22 cm/year, far greater than the predefined effect size. The gain in height SDS at week 26 was 0.57+/-0.27 (p<0.0001). Bone age significantly increased after GH treatment, however, bone maturation rate (bone age for chronological age) showed limited advancement. This 26-week GH treatment was effective in increasing serum levels of insulin-like growth factor (IGF)-I and IGF binding protein (IGFBP)-3 from baseline (p<0.0001). Eutropin was well tolerated and there were no withdrawals due to adverse events. No clinically significant changes in laboratory values were observed. CONCLUSION: This 6-month daily GH treatment in children with ISS demonstrated increased height velocity, improved height SDS, and increased IGF-I and IGFBP-3 levels with a favorable safety profile.
