Long-Term Study of Growtropin-II Treatment for Children with Short Stature from Various Causes Assessing Safety and Growth Outcomes

What this Trial Is About

Researchers are studying the long-term safety and effectiveness of Growtropin44-II treatment in children who have short stature due to various causes such as growth hormone deficiency, idiopathic short stature, Turner syndrome, or being small for gestational age. The study aims to gather information on how this treatment affects growth over an extended period, including after bone growth has stopped. Participants receive Growtropin44-II, a form of growth hormone, and are observed over time to assess its impact. The study follows children who have official height records for at least six months before joining and tracks their growth and health outcomes, focusing on changes in height velocity, skeletal maturity, and related biomarkers until up to two years after their bones have stopped growing. Throughout the study, children will have their height, growth rates, bone maturity, and levels of growth-related proteins like IGF-1 and IGFBP-3 monitored. Researchers will also record any adverse events to evaluate safety. This monitoring continues for up to two years after the participants experience epiphyseal closure, ensuring comprehensive long-term follow-up of growth and health outcomes.

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