Efficacy of short-term growth hormone treatment in prepubertal children with idiopathic short stature

Ho Seong Kim, 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

Research output: Contribution to journalArticle

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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 ®) 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.

Original languageEnglish
Pages (from-to)53-60
Number of pages8
JournalYonsei Medical Journal
Volume55
Issue number1
DOIs
Publication statusPublished - 2014 Jan 1

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Growth Hormone
Insulin-Like Growth Factor Binding Protein 3
Therapeutics
Insulin-Like Growth Factor I
Bone and Bones
Growth
Safety
Insulin-Like Growth Factor Binding Proteins
Human Growth Hormone
Korea
Multicenter Studies
Confidence Intervals
Serum

Keywords

  • Child
  • Growth hormone
  • Idiopathic
  • Safety
  • Short stature
  • Treatment outcome

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Kim, H. S., Yang, S. W., Yoo, H. W., Suh, B. K., Ko, C. W., Chung, W. Y., ... Kim, D. H. (2014). Efficacy of short-term growth hormone treatment in prepubertal children with idiopathic short stature. Yonsei Medical Journal, 55(1), 53-60. https://doi.org/10.3349/ymj.2014.55.1.53

Efficacy of short-term growth hormone treatment in prepubertal children with idiopathic short stature. / Kim, Ho Seong; Yang, Sei Won; Yoo, Han Wook; Suh, Byung Kyu; Ko, Cheol Woo; Chung, Woo Yeong; Lee, Kee Hyoung; Hwang, Jin Soon; Ji, Hyi Jeong; Ahn, Hyunji; Kim, Duk Hee.

In: Yonsei Medical Journal, Vol. 55, No. 1, 01.01.2014, p. 53-60.

Research output: Contribution to journalArticle

Kim, HS, Yang, SW, Yoo, HW, Suh, BK, Ko, CW, Chung, WY, Lee, KH, Hwang, JS, Ji, HJ, Ahn, H & Kim, DH 2014, 'Efficacy of short-term growth hormone treatment in prepubertal children with idiopathic short stature', Yonsei Medical Journal, vol. 55, no. 1, pp. 53-60. https://doi.org/10.3349/ymj.2014.55.1.53
Kim, Ho Seong ; Yang, Sei Won ; Yoo, Han Wook ; Suh, Byung Kyu ; Ko, Cheol Woo ; Chung, Woo Yeong ; Lee, Kee Hyoung ; Hwang, Jin Soon ; Ji, Hyi Jeong ; Ahn, Hyunji ; Kim, Duk Hee. / Efficacy of short-term growth hormone treatment in prepubertal children with idiopathic short stature. In: Yonsei Medical Journal. 2014 ; Vol. 55, No. 1. pp. 53-60.
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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 {\circledR}) 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.",
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AU - Ko, Cheol Woo

AU - Chung, Woo Yeong

AU - Lee, Kee Hyoung

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AU - Kim, Duk Hee

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N2 - 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 ®) 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.

AB - 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 ®) 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.

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KW - Treatment outcome

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