Effect of Growth Hormone Therapy on Height Velocity in Korean Children with Idiopathic Short Stature: A Phase III Randomised Controlled Trial
- Authors
- Chung, Woo Yeong; Yoo, Han-Wook; Hwang, Jin Soon; Ko, Cheol Woo; Kim, Ho-Seong; Jin, Dong-Kyu; Lee, Kee-Hyoung; Han, Heon-Seok; Paranchothy, Premila; Suh, Byung-Kyu
- Issue Date
- 2018
- Publisher
- KARGER
- Keywords
- Idiopathic short stature; Recombinant human growth hormone; Height velocity; Efficacy; Safety
- Citation
- HORMONE RESEARCH IN PAEDIATRICS, v.90, no.1, pp.44 - 53
- Indexed
- SCIE
SCOPUS
- Journal Title
- HORMONE RESEARCH IN PAEDIATRICS
- Volume
- 90
- Number
- 1
- Start Page
- 44
- End Page
- 53
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/80934
- DOI
- 10.1159/000491016
- ISSN
- 1663-2818
- Abstract
- Background/Aims: The SYNERGY (Saizen (R) for Your New Life and Brighter Tomorrow without Growth Deficiency) study is the first randomised multi-centre, open-label study to assess the short-term efficacy and safety of this recombinant human growth hormone (r-hGH) preparation for prepubertal children with idiopathic short stature in South Korea. Methods: The SYNERGY study (ClinicalTrials.gov NCT01746862) was conducted at 9 centres throughout South Korea between December 2012 and March 2015. The primary endpoint was difference in height velocity from baseline to 6 months in the treatment and control arms. Results: 97 children were screened; 90 were randomly assigned: 60 children to 0.067 mg/kg/day r-hGH for 12 months (treatment) and 30 children to 6 months of no treatment followed by 0.067 mg/kg/day r-hGH for 6 months (control). The 6-month mean height velocity in the treatment group increased from 5.63 cm/year (SD 1.62) to 10.08 cm/year (SD 1.92) (p<0.0001) and from 4.94 cm/year (SD 1.91) to 5.92 cm/year (SD 2.01) (p = 0.0938) in the control group (between-group difference 3.47 cm/year, 95% CI 2.17-4.78; p < 0.0001). Adherence was > 90% throughout the study. The safety profile was consistent with that already known for r-hGH. Conclusion: Treatment with r-hGH in the SYNERGY study demonstrated a statistically significant increase in height velocity at 6 months. (C) 2018 S. Karger AG, Basel
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Collections - College of Medicine > Department of Medical Science > 1. Journal Articles
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