This clinical trial is focused on studying a condition known as Osteogenesis Imperfecta, which is a genetic disorder characterized by fragile bones that break easily. The study aims to evaluate the effectiveness and safety of a medication called Romosozumab, which is administered as a solution for injection. Romosozumab is being compared to another type of medication known as Bisphosphonates, which are commonly used to treat bone-related conditions. The purpose of the study is to assess how well Romosozumab works in reducing the number of bone fractures in children and adolescents with Osteogenesis Imperfecta over a 12-month period.
Participants in the study will receive either Romosozumab or Bisphosphonates. Romosozumab is given through a subcutaneous injection, which means it is injected under the skin, while Bisphosphonates are typically given as a solution for infusion, meaning they are administered directly into the bloodstream. The study will also involve the use of Calcium and Ergocalciferol (a form of vitamin D) in tablet form to support bone health. The trial will last for a total of 12 months, during which the number of fractures and changes in bone density will be monitored.
Throughout the study, participants will have regular check-ups to monitor their bone health and overall well-being. The study will also measure changes in bone density using a method called DXA (Dual-energy X-ray Absorptiometry), which is a type of imaging test that helps assess bone strength. The goal is to determine if Romosozumab is more effective than Bisphosphonates in reducing fractures and improving bone density in young patients with Osteogenesis Imperfecta.



Austria
Belgium
France
Germany
Hungary
Italy
Poland
Slovakia
Spain