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

What this Trial Is About

Researchers are evaluating the long-term safety and effectiveness of Growtropin4-II treatment in children with short stature caused by growth hormone deficiency, idiopathic short stature, Turner syndrome, or small for gestational age conditions. This observational study aims to monitor how this treatment affects growth over an extended period, up to two years after the bones have stopped growing (epiphyseal closure). The study is sponsored by Dong-A ST Co., Ltd. Participants receive Growtropin4-II as part of their treatment, and the study tracks outcomes without altering their usual care. The focus is on observing the natural course of treatment and its effects over time through routine medical records and assessments. The study includes data collected both prospectively and retrospectively from multiple centers. Throughout the study, researchers will review participants' height growth velocity, height compared to target adult height, changes in height standard deviation scores, skeletal maturity, and levels of IGF-1, IGFBP-3, and BMI. Safety is closely monitored by recording any adverse events up to two years after bone growth ends. Participation duration varies depending on the individual timing of epiphyseal closure, with ongoing observation to understand long-term results.

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