Safety Follow-up Study to Assess the Safety of Romosozumab in Children and Adolescents with Osteogenesis Imperfecta

The primary objective is to evaluate the safety of romosozumab in pediatric patients diagnosed with osteogenesis imperfecta who have previously completed Study 20200105. This assessment applies to participants regardless of whether they received the full protocol-specified dose of the investigational product or discontinued treatment early.

This clinical trial includes 39 participants diagnosed with osteogenesis imperfecta. The study population consists of both male and female patients, including vulnerable individuals. The cohort is composed of participants who were previously randomized to the romosozumab arm and completed the preceding study through the 15-month visit, regardless of whether the investigational product was administered until the final protocol-specified dose or discontinued early. Inclusion requires that informed consent or assent has been obtained from the participant or their legally authorized representative prior to the initiation of any study-specific procedures.

This multicenter, phase 5 study is designed as a safety follow-up to assess the safety of romosozumab in children and adolescents previously diagnosed with osteogenesis imperfecta. The research methodology focuses on evaluating adverse events in participants who have completed a prior clinical trial, identified as Study 20200105. Eligible individuals include those who were randomized to the investigational product arm and completed the 15-month visit, regardless of whether they received the full course of the subcutaneous injection or discontinued treatment early. The study aims to monitor safety outcomes following the administration of romosozumab. Specific details regarding the sequence of study visits, total duration of participant involvement, and conditions for early termination are not provided.

The investigational product is romosozumab, provided as a solution for injection. This medication is administered via subcutaneous injection using either a pre-filled syringe or a pre-filled pen. The dosage is 105 mg per administration.

The provided source material does not contain information regarding the assessment of efficacy. The study is designed to evaluate the safety of romosozumab in participants with osteogenesis imperfecta.