Design of the long-term observational cohort study with recombinant human growth hormone in Korean children: LG Growth Study
Annals of Pediatric Endocrinology & Metabolism
;
: 43-50, 2018.
Article
in English
| WPRIM
| ID: wpr-713443
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Turner Syndrome
/
Growth Hormone
/
Prospective Studies
/
Cohort Studies
/
Follow-Up Studies
/
Gestational Age
/
Human Growth Hormone
/
Genitalia
/
Kidney Failure, Chronic
Type of study:
Etiology study
/
Incidence study
/
Observational study
/
Prognostic study
/
Risk factors
Limits:
Child
/
Humans
Language:
English
Journal:
Annals of Pediatric Endocrinology & Metabolism
Year:
2018
Type:
Article
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