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Efficacy and Safety Evaluation of Human Growth Hormone Therapy in Patients with Idiopathic Short Stature in Korea - A Randomised Controlled Trial

Authors
 Min Ho Jung  ;  Byung-Kyu Suh  ;  Cheol Woo Ko  ;  Kee-Hyoung Lee  ;  Dong-Kyu Jin  ;  Han-Wook Yoo  ;  Jin Soon Hwang  ;  Woo Yeong Chung  ;  Heon-Seok Han  ;  Vinay Prusty  ;  Ho-Seong Kim 
Citation
 European Endocrinology, Vol.16(1) : 54-59, 2020-03 
Journal Title
European Endocrinology
ISSN
 1758-3772 
Issue Date
2020-03
Keywords
Human growth hormone ; clinical trial ; idiopathic ; short stature
Abstract
Background: This trial evaluated the efficacy and safety of growth hormone (GH) therapy (Norditropin®; Novo Nordisk, Bagsværd, Denmark) in paediatric patients with idiopathic short stature (ISS) in Korea.

Methods: This was an open-label, parallel-group, multicentre, interventional trial (ClinicalTrials.gov identifier: NCT01778023). Pre-pubertal patients (mean age 6.2 years; height, 107.1 cm) were randomised 2:1 to 12 months' GH treatment (0.469 mg/kg/week; group A, n=36) or 6 months untreated followed by 6 months' GH treatment (group B, n=18). Safety analysis was based on adverse events (AEs) in all GH-treated patients.

Results: After 6 months, height velocity (Ht-V), change in both height standard deviation score (Ht-SDS) and insulin-like growth factor 1 (mean difference [95% confidence interval {CI}]: 5.15 cm/year [4.09, 6.21]; 0.57 [0.43, 0.71]; 164.56 ng/mL [112.04, 217.08], respectively; all p<0.0001) were greater in group A than in group B. Mean difference in Ht-V for 0-6 months versus 6-12 months was 2.80 cm/year (95% CI 1.55, 4.04) for group A and -4.60 cm/year (95% CI -6.12, -3.09; both p<0.0001) for group B. No unexpected AEs were reported.

Conclusions: During the first 6 months, height was significantly increased in GH-treated patients versus untreated patients with ISS. Safety of GH was consistent with the known safety profile.
Files in This Item:
T999202148.pdf Download
DOI
10.17925/EE.2020.16.1.54
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiation Oncology (방사선종양학교실) > 1. Journal Papers
Yonsei Authors
Kim, Dong Wook(김동욱) ORCID logo https://orcid.org/0000-0002-5819-9783
Kim, Jinsung(김진성) ORCID logo https://orcid.org/0000-0003-1415-6471
Kim, Ho Seong(김호성) ORCID logo https://orcid.org/0000-0003-1135-099X
Shin, Jae Il(신재일) ORCID logo https://orcid.org/0000-0003-2326-1820
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/184924
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