Amgen Initiates Phase III Trial of SOST Monoclonal Antibody Romosozumab in Pediatric and Adolescent Osteogenesis Imperfecta

April 23,The official website of the Drug Clinical Trial Registration and Information Disclosure Platform shows that Amgen has registered aComparison of Romosozumab（RomosozumabA Phase III, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of Bisphosphonates in the Treatment of Children and Adolescents with Osteogenesis Imperfecta。

Source:Official Website of Drug Clinical Trial Registration and Information Disclosure Platform

The study plans to enroll 113 subjects, including 7 in China and 106 internationally.The primary endpoint based on FDA requirements is clinical fractures up to Month 12.(Clinical Vertebral Fractures and Non-Vertebral Fractures)Quantity.

Based on EMA requirements, the two endpoints are any fractures up to the 12th month.(New vertebral fractures and worsening of vertebral fractures, whether clinically symptomatic or asymptomatic, and non-vertebral fractures)Quantity. Lumbar BMD Z-score at Month 12(According to DXA evaluation)Change from baseline.

In addition, there isAdverse events during treatment, incidence of Romosozumab antibodies in subjects, changes in laboratory test values and vital signs compared to baseline.

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