PMID- 32595770
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 1758-3780 (Electronic)
IS  - 1758-3772 (Print)
IS  - 1758-3772 (Linking)
VI  - 16
IP  - 1
DP  - 2020 Apr
TI  - Efficacy and Safety Evaluation of Human Growth Hormone Therapy in Patients with 
      Idiopathic Short Stature in Korea - A Randomised Controlled Trial.
PG  - 54-59
LID - 10.17925/EE.2020.16.1.54 [doi]
AB  - BACKGROUND: This trial evaluated the efficacy and safety of growth hormone (GH) 
      therapy (Norditropin(R); Novo Nordisk, Bagsvaerd, 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.
CI  - (c) Touch Medical Media 2020.
FAU - Jung, Min Ho
AU  - Jung MH
AD  - The Catholic University of Korea, Yeouido St. Mary's Hospital, Seoul, South 
      Korea.
FAU - Suh, Byung-Kyu
AU  - Suh BK
AD  - The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, South Korea.
FAU - Ko, Cheol Woo
AU  - Ko CW
AD  - Kyungpook National University Hospital, Daegu, South Korea.
FAU - Lee, Kee-Hyoung
AU  - Lee KH
AD  - Korea University Anam Hospital, Seoul, South Korea.
FAU - Jin, Dong-Kyu
AU  - Jin DK
AD  - Samsung Medical Center, Sung Kyun Kwan University, Seoul, South Korea.
FAU - Yoo, Han-Wook
AU  - Yoo HW
AD  - Asan Medical Center, Seoul, South Korea.
FAU - Hwang, Jin Soon
AU  - Hwang JS
AD  - Ajou University Hospital, Suwon, South Korea.
FAU - Chung, Woo Yeong
AU  - Chung WY
AD  - Inje University Busan Paik Hospital, Busan, South Korea.
FAU - Han, Heon-Seok
AU  - Han HS
AD  - Chungbuk National University Hospital, Chungbuk National University College of 
      Medicine, Cheongju, South Korea.
FAU - Prusty, Vinay
AU  - Prusty V
AD  - Novo Nordisk Pharma Gulf FZ-LLC, Dubai, United Arab Emirates.
FAU - Kim, Ho-Seong
AU  - Kim HS
AD  - Severance Hospital, Yonsei University Health System, Seoul, South Korea.
LA  - eng
SI  - ClinicalTrials.gov/NCT01778023
PT  - Journal Article
DEP - 20191015
PL  - England
TA  - Eur Endocrinol
JT  - European endocrinology
JID - 101574781
PMC - PMC7308103
OTO - NOTNLM
OT  - Human growth hormone
OT  - clinical trial
OT  - idiopathic
OT  - short stature
COIS- Disclosures: Heon-Seok Han received clinical research funding from Novo Nordisk. 
      Vinay Prusty was an employee of Novo Nordisk Pharma Korea Ltd at the time of the 
      study. Min Ho Jung, Byung-Kyu Suh, Cheol Woo Ko, Kee-Hyoung Lee, Dong-Kyu Jin, 
      Han-Wook Yoo, Jin Soon Hwang, Woo Yeong Chung and Ho-Seong Kim have no financial 
      or non-financial relationships or activities to declare in relation to this 
      article.
EDAT- 2020/07/01 06:00
MHDA- 2020/07/01 06:01
PMCR- 2020/04/01
CRDT- 2020/06/30 06:00
PHST- 2019/03/21 00:00 [received]
PHST- 2019/07/07 00:00 [accepted]
PHST- 2020/06/30 06:00 [entrez]
PHST- 2020/07/01 06:00 [pubmed]
PHST- 2020/07/01 06:01 [medline]
PHST- 2020/04/01 00:00 [pmc-release]
AID - 10.17925/EE.2020.16.1.54 [doi]
PST - ppublish
SO  - Eur Endocrinol. 2020 Apr;16(1):54-59. doi: 10.17925/EE.2020.16.1.54. Epub 2019 
      Oct 15.