Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature

Open, Multi-center, Non-interventional, Prospective/ Retrospective Observational Study on Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature

This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.

Study Overview

• Status: Recruiting
• Conditions: Growth Hormone Deficiency; Turner Syndrome; Small for Gestational Age; Idiopathic Short Stature

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Sung; Phone Number: +82-2-920-8369; Email: jhsung@donga.co.kr

Study Locations

• South Korea
  • Seodaemun-gu
    • Seoul, Seodaemun-gu, South Korea, 03722
      • Recruiting
      • Yonsei University Health System, Severance Hospital
      • Contact: Ho Seong Kim, M.D., Ph.D; Phone Number: +82-2-2228-2069; Email: kimho@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Short stature by GHD or ISS or TS or SGA

Description

Inclusion Criteria:

• Children with short stature by growth hormone deficiency(GHD) or idiopathic short stature (ISS) or turner's syndrome(TS) or small for gestational age(SGA)
• Children who has official height record at least 6 months prior

Exclusion Criteria:

• Children with Epiphyseal closure

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Growth hormone; Growtropin®-II

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long term safety assessed through the adverse events	Number of occurrence of treatment-related adverse events	Up to 2 years after epiphyseal closure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of annualized height velocity	To assess the difference in change of annualized height velocity between baseline and every 6 months	Up to 2 years after epiphyseal closure
The difference between target height and final height	To assess the difference in target height and final height	Up to 2 years after epiphyseal closure
Changes in Height SDS	To assess the changes in Height SDS between baseline and every 6 months	Up to 2 years after epiphyseal closure
Changes in skeletal maturity	To assess the changes in skeletal maturity between baseline and every 6 months	Up to 2 years after epiphyseal closure
Changes in IGF-1	To assess the changes in IGF-1 between baseline and every 6 months	Up to 2 years after epiphyseal closure
Changes in IGFBP-3	To assess the changes in IGFBP-3 between baseline and every 6 months	Up to 2 years after epiphyseal closure
Changes in BMI SDS	To assess the changes in BMI SDS between baseline and every 6 months	Up to 2 years after epiphyseal closure

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Estimated): February 1, 2035
• Study Completion (Estimated): February 1, 2035

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 19, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Genetic Diseases, Inborn; Gonadal Disorders; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Disorders of Sex Development; Urogenital Abnormalities; Hypothalamic Diseases; Pituitary Diseases; Bone Diseases, Endocrine; Sex Chromosome Disorders; Chromosome Disorders; Bone Diseases, Developmental; Dwarfism; Hypopituitarism; Sex Chromosome Disorders of Sex Development; Gonadal Dysgenesis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dwarfism, Pituitary; Turner Syndrome
• Other Study ID Numbers: DA3002_SS_OS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No