Efficacy and safety evaluation of human growth hormone therapy in patients with idiopathic short stature in Korea - A randomised controlled trial
- Authors
- Jung, M.H.; Suh, B.-K.; Ko, C.W.; Lee, K.-H.; Jin, D.-K.; Yoo, H.-W.; Hwang, J.S.; Chung, W.Y.; Han, H.-S.; Prusty, V.; Kim, H.-S.
- Issue Date
- 2020
- Publisher
- Touch Briefings
- Keywords
- Clinical trial; Human growth hormone; Idiopathic; Short stature
- Citation
- European Endocrinology, v.16, no.1, pp.54 - 59
- Indexed
- SCOPUS
- Journal Title
- European Endocrinology
- Volume
- 16
- Number
- 1
- Start Page
- 54
- End Page
- 59
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/60768
- DOI
- 10.17925/EE.2020.16.1.54
- ISSN
- 1758-3772
- 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. © Touch Medical Media 2020.
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