Design of the long-term observational cohort study with recombinant human growth hormone in Korean children: LG Growth Study.
10.6065/apem.2018.23.1.43
- Author:
Sochung CHUNG
1
;
Jae Ho YOO
;
Jin Ho CHOI
;
Young Jun RHIE
;
Hyun Wook CHAE
;
Jae Hyun KIM
;
Il Tae HWANG
;
Choong Ho SHIN
;
Eun Young KIM
;
Kee Hyoung LEE
Author Information
1. Department of Pediatrics, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea.
- Publication Type:Original Article
- Keywords:
Growth hormone deficiency;
Turner syndrome;
Chronic renal failure;
Small for gestational age;
Idiopathic short stature
- MeSH:
Child*;
Cohort Studies*;
Follow-Up Studies;
Genitalia;
Gestational Age;
Growth Hormone;
Human Growth Hormone*;
Humans*;
Kidney Failure, Chronic;
Prospective Studies;
Turner Syndrome
- From:Annals of Pediatric Endocrinology & Metabolism
2018;23(1):43-50
- CountryRepublic of Korea
- Language:English
-
Abstract:
PURPOSE: Regarding recombinant human growth hormone (rhGH) use in the pediatric population, no long-term follow-up data are available for Korean patients. To fill in the gap of knowledge, a registry study (LG Growth Study) was initiated to assess the safety and effectiveness of four types of rhGH products in real-life settings. METHODS: A total of 4,000 children will be registered and prospectively followed up at 6-month intervals until 2 years after epiphyseal closure to collect data on treatment and adverse events, with primary interest in malignancies and growth outcomes. RESULTS: As of 22 March 2017, approximately 50% (2,024) of the target number of patients have been included in the analysis set: growth hormone deficiency, 1,297 (64.1%); idiopathic short stature, 315 (15.6%); small for gestational age, 206 (10.2%); Turner syndrome, 197 (9.7%); and chronic renal failure, 9 (0.4%). At baseline, median age (years) was 8 (interquartile range [IQR], 5–11); 52% (1,048) were boys; and the majority were at Tanner stage I (83% based on breast/external genitalia, 97% on pubic hair). Median height standard deviation score was -2.26 (IQR, -2.69 to -2.0), and median bone age delay (years) was -1.46 (IQR, -2.26 to -0.78). CONCLUSIONS: This registry study will provide the opportunity to assess the risk of malignancies as well as the general safety data in Korean pediatric patients receiving rhGH. In addition, the long-term effectiveness of rhGH and comparative data between different disease entities will provide practical insight on the standard rhGH treatment.
