Recombinant growth hormone therapy for prepubertal children with idiopathic short stature in Korea: a phase III randomized trial

J. Kim, B. K. Suh, C. W. Ko, Kee Hyoung Lee, C. H. Shin, J. S. Hwang, H. S. Kim, W. Y. Chung, C. J. Kim, H. S. Han, N. Y. Kwon, S. Y. Cho, H. W. Yoo, D. K. Jin

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Purpose: Several studies have evaluated the effects of growth hormone (GH) on auxological and biochemical parameters in children with non-GH-deficient, idiopathic short stature (ISS). This study evaluated the efficacy and safety of Growtropin®-II (recombinant human GH) in Korean patients with ISS. Methods: This was a 1-year, open-label, multicenter, phase III randomized trial of Growtropin®-II in Korean patients with ISS. In total, 70 prepubertal subjects (39 males, 31 females) between 4 and 12 years of age were included in the study. All patients were naive to GH treatment. Results: Annual height velocity was significantly higher in the treatment group (10.68 ± 1.95 cm/year) than the control group (5.72 ± 1.72, p < 0.001). Increases in height and weight standard deviation scores (SDSs) at 26 weeks were 0.63 ± 0.16 and 0.64 ± 0.46, respectively, for the treatment group, and 0.06 ± 0.15 and 0.06 ± 0.28, respectively, for the control group (p < 0.001). Serum insulin-like growth factor (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3) increased significantly in the treatment group at week 26 compared to baseline. However, the SDS for body mass index (BMI) at 26 weeks did not change significantly in either group. Growtropin®-II was well tolerated and safe over 1 year of treatment. Conclusions: One-year GH treatment for prepubertal children with ISS demonstrated increased annualized velocity, height and weight SDSs, and IGF-1 and IGFBP-3 levels, with a favorable safety profile. Further evaluations are needed to determine the optimal dose, final adult height, and long-term effects of ISS treatment.

Original languageEnglish
Pages (from-to)1-9
Number of pages9
JournalJournal of Endocrinological Investigation
DOIs
Publication statusAccepted/In press - 2017 Nov 4

Fingerprint

Korea
Growth Hormone
Insulin-Like Growth Factor Binding Protein 3
Insulin-Like Growth Factor I
Therapeutics
Safety
Weights and Measures
Control Groups
Human Growth Hormone
Somatomedins
Body Mass Index
Hormones
Serum

Keywords

  • Clinical trial
  • Growth hormone
  • Idiopathic short stature

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Recombinant growth hormone therapy for prepubertal children with idiopathic short stature in Korea : a phase III randomized trial. / Kim, J.; Suh, B. K.; Ko, C. W.; Lee, Kee Hyoung; Shin, C. H.; Hwang, J. S.; Kim, H. S.; Chung, W. Y.; Kim, C. J.; Han, H. S.; Kwon, N. Y.; Cho, S. Y.; Yoo, H. W.; Jin, D. K.

In: Journal of Endocrinological Investigation, 04.11.2017, p. 1-9.

Research output: Contribution to journalArticle

Kim, J. ; Suh, B. K. ; Ko, C. W. ; Lee, Kee Hyoung ; Shin, C. H. ; Hwang, J. S. ; Kim, H. S. ; Chung, W. Y. ; Kim, C. J. ; Han, H. S. ; Kwon, N. Y. ; Cho, S. Y. ; Yoo, H. W. ; Jin, D. K. / Recombinant growth hormone therapy for prepubertal children with idiopathic short stature in Korea : a phase III randomized trial. In: Journal of Endocrinological Investigation. 2017 ; pp. 1-9.
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title = "Recombinant growth hormone therapy for prepubertal children with idiopathic short stature in Korea: a phase III randomized trial",
abstract = "Purpose: Several studies have evaluated the effects of growth hormone (GH) on auxological and biochemical parameters in children with non-GH-deficient, idiopathic short stature (ISS). This study evaluated the efficacy and safety of Growtropin{\circledR}-II (recombinant human GH) in Korean patients with ISS. Methods: This was a 1-year, open-label, multicenter, phase III randomized trial of Growtropin{\circledR}-II in Korean patients with ISS. In total, 70 prepubertal subjects (39 males, 31 females) between 4 and 12 years of age were included in the study. All patients were naive to GH treatment. Results: Annual height velocity was significantly higher in the treatment group (10.68 ± 1.95 cm/year) than the control group (5.72 ± 1.72, p < 0.001). Increases in height and weight standard deviation scores (SDSs) at 26 weeks were 0.63 ± 0.16 and 0.64 ± 0.46, respectively, for the treatment group, and 0.06 ± 0.15 and 0.06 ± 0.28, respectively, for the control group (p < 0.001). Serum insulin-like growth factor (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3) increased significantly in the treatment group at week 26 compared to baseline. However, the SDS for body mass index (BMI) at 26 weeks did not change significantly in either group. Growtropin{\circledR}-II was well tolerated and safe over 1 year of treatment. Conclusions: One-year GH treatment for prepubertal children with ISS demonstrated increased annualized velocity, height and weight SDSs, and IGF-1 and IGFBP-3 levels, with a favorable safety profile. Further evaluations are needed to determine the optimal dose, final adult height, and long-term effects of ISS treatment.",
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T1 - Recombinant growth hormone therapy for prepubertal children with idiopathic short stature in Korea

T2 - a phase III randomized trial

AU - Kim, J.

AU - Suh, B. K.

AU - Ko, C. W.

AU - Lee, Kee Hyoung

AU - Shin, C. H.

AU - Hwang, J. S.

AU - Kim, H. S.

AU - Chung, W. Y.

AU - Kim, C. J.

AU - Han, H. S.

AU - Kwon, N. Y.

AU - Cho, S. Y.

AU - Yoo, H. W.

AU - Jin, D. K.

PY - 2017/11/4

Y1 - 2017/11/4

N2 - Purpose: Several studies have evaluated the effects of growth hormone (GH) on auxological and biochemical parameters in children with non-GH-deficient, idiopathic short stature (ISS). This study evaluated the efficacy and safety of Growtropin®-II (recombinant human GH) in Korean patients with ISS. Methods: This was a 1-year, open-label, multicenter, phase III randomized trial of Growtropin®-II in Korean patients with ISS. In total, 70 prepubertal subjects (39 males, 31 females) between 4 and 12 years of age were included in the study. All patients were naive to GH treatment. Results: Annual height velocity was significantly higher in the treatment group (10.68 ± 1.95 cm/year) than the control group (5.72 ± 1.72, p < 0.001). Increases in height and weight standard deviation scores (SDSs) at 26 weeks were 0.63 ± 0.16 and 0.64 ± 0.46, respectively, for the treatment group, and 0.06 ± 0.15 and 0.06 ± 0.28, respectively, for the control group (p < 0.001). Serum insulin-like growth factor (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3) increased significantly in the treatment group at week 26 compared to baseline. However, the SDS for body mass index (BMI) at 26 weeks did not change significantly in either group. Growtropin®-II was well tolerated and safe over 1 year of treatment. Conclusions: One-year GH treatment for prepubertal children with ISS demonstrated increased annualized velocity, height and weight SDSs, and IGF-1 and IGFBP-3 levels, with a favorable safety profile. Further evaluations are needed to determine the optimal dose, final adult height, and long-term effects of ISS treatment.

AB - Purpose: Several studies have evaluated the effects of growth hormone (GH) on auxological and biochemical parameters in children with non-GH-deficient, idiopathic short stature (ISS). This study evaluated the efficacy and safety of Growtropin®-II (recombinant human GH) in Korean patients with ISS. Methods: This was a 1-year, open-label, multicenter, phase III randomized trial of Growtropin®-II in Korean patients with ISS. In total, 70 prepubertal subjects (39 males, 31 females) between 4 and 12 years of age were included in the study. All patients were naive to GH treatment. Results: Annual height velocity was significantly higher in the treatment group (10.68 ± 1.95 cm/year) than the control group (5.72 ± 1.72, p < 0.001). Increases in height and weight standard deviation scores (SDSs) at 26 weeks were 0.63 ± 0.16 and 0.64 ± 0.46, respectively, for the treatment group, and 0.06 ± 0.15 and 0.06 ± 0.28, respectively, for the control group (p < 0.001). Serum insulin-like growth factor (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3) increased significantly in the treatment group at week 26 compared to baseline. However, the SDS for body mass index (BMI) at 26 weeks did not change significantly in either group. Growtropin®-II was well tolerated and safe over 1 year of treatment. Conclusions: One-year GH treatment for prepubertal children with ISS demonstrated increased annualized velocity, height and weight SDSs, and IGF-1 and IGFBP-3 levels, with a favorable safety profile. Further evaluations are needed to determine the optimal dose, final adult height, and long-term effects of ISS treatment.

KW - Clinical trial

KW - Growth hormone

KW - Idiopathic short stature

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