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Design of the long-term observational cohort study with recombinant human growth hormone in Korean children: LG

Sochung Chung1, Jae-Ho Yoo2, Jin Ho Choi3

  • 1Department of Pediatrics, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea.

Annals of Pediatric Endocrinology & Metabolism
|April 4, 2018
PubMed

Insights

This registry study tracks Korean children using recombinant human growth hormone (rhGH) to assess its safety and effectiveness. It aims to provide crucial long-term data on growth outcomes and adverse events in this population.

Area of Science:

  • Pediatric Endocrinology
  • Pharmacovigilance
  • Growth Hormone Therapy

Background:

  • Limited long-term follow-up data exist for recombinant human growth hormone (rhGH) use in Korean pediatric patients.
  • Real-world data are essential for understanding the safety and effectiveness of rhGH treatments.
  • A comprehensive registry study is needed to address this knowledge gap.

Purpose of the Study:

  • To establish a registry (LG Growth Study) for assessing the safety and effectiveness of four rhGH products in Korean children.
  • To collect prospective data on treatment and adverse events, with a focus on malignancies and growth outcomes.
  • To provide long-term follow-up data in a real-life clinical setting.

Main Methods:

  • Prospective enrollment of 4,000 children for follow-up at 6-month intervals.
  • Data collection until 2 years post-epiphyseal closure, focusing on malignancies and growth.
  • Inclusion of diverse pediatric conditions, including growth hormone deficiency and idiopathic short stature.

Main Results:

  • As of March 2017, 2,024 patients were included, with growth hormone deficiency being the most common indication (64.1%).
  • Baseline characteristics included a median age of 8 years, with 52% males and predominantly Tanner stage I.
  • Median height standard deviation score was -2.26, and median bone age delay was -1.46 years.

Conclusions:

  • The LG Growth Study will offer valuable insights into the safety profile, including malignancy risk, of rhGH in Korean pediatric patients.
  • Long-term effectiveness data will be generated, aiding in understanding standard rhGH treatment protocols.
  • Comparative analyses between different disease entities will inform clinical decision-making.
Abstract

Keywords:
Chronic renal failureGrowth hormone deficiencyIdiopathic short statureSmall for gestational ageTurner syndrome

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