Amgen and UCB recently announced the results of the Phase 3 trial for romosozumab.
The companies reported that the investigational drug showed a substantial increase hip bone mineral density (BMD) and overall strength when measured against teriparatide in women who are postmenopausal with osteoporosis that are coming off of bisphosphonate therapy.
The data that was released by Amgen and UCB came from the STRUCTURE study (Study evaluating effect of romosozumab compared with teriparatide in postmenopausal women with osteoporosis at high risk for fracture previously treated with bisphosphonate), which was randomized, open-label and conducted in multiple centers worldwide. The findings from the STRUCTURE study were presented at the ENDO 2016, the Endocrine Society’s 98th annual Meeting & Expo in Boston, during an oral presentation.
The trial was conducted using 436 women that were an average of 72 years old. All patients taking part in the study were postmenopausal and had osteoporosis with a history of non-vertebral fracture after 50 years of age, or vertebral fracture that required bisphosphonate therapy for three years or more before their transition to romosozumab or teriparatide therapy. The patients received either subcutaneous romosozsumab once a month or subcutaneous teriparatide daily for 12 months.