Amgen Inc ((AMGN)) announced an update on their ongoing clinical study.
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Amgen Inc. is conducting a Phase 3 study titled ‘A Phase 3, Open-Label, Multicenter, Randomized Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta.’ The study aims to assess the efficacy and safety of romosozumab versus bisphosphonates, focusing on reducing clinical fractures and improving bone mineral density in young patients with osteogenesis imperfecta.
The study tests two interventions: Romosozumab, an experimental drug administered monthly via subcutaneous injection, and bisphosphonates, the standard care treatment determined by local protocols. Both treatments are evaluated over a 12-month period.
This interventional study employs a randomized, parallel assignment model without masking, primarily aimed at treatment evaluation. The design facilitates a direct comparison of the two interventions’ effectiveness and safety.
The study began on April 22, 2024, with primary completion expected within 12 months. The last update was submitted on June 25, 2025, indicating ongoing recruitment and data collection.
Amgen’s study could significantly impact its stock performance, as positive results may enhance investor confidence and market position, particularly in the competitive osteogenesis imperfecta treatment landscape. The study’s outcome could influence market dynamics, especially if romosozumab proves superior to existing treatments.
The study is currently recruiting, with further details accessible on the ClinicalTrials portal.