Top-Line Results for Investigational Osteoporosis Drug
Amgen and UCB announced top-line results from the STRUCTURE trial (STudy evaluating effect of RomosozUmab Compared with Teriparatide in postmenopaUsal women with osteoporosis at high risk for fracture pReviously treated with bisphosphonatE therapy).
STRUCTURE was a Phase 3, multi-center, international, randomized, open-label, teriparatide-controlled study that evaluated safety, tolerability and efficacy of romosozumab in women with postmenopausal osteoporosis. A total of 436 patients previously treated with bisphosphonate therapy received either subcutaneous romosozumab (210mg monthly) or subcutaneous teriparatide (20mcg daily) through month 12. The study met the primary endpoint, demonstrating a statistically significant difference in favor of romosozumab in the percent change of total hip bone mineral density (measured by DXA) through month 12.
Romosozumab is an investigational bone-forming monoclonal antibody designed to work by inhibiting the protein sclerostin, thereby increasing bone formation and decreasing bone breakdown. Further analysis of the Phase 3 STRUCTURE study results are ongoing and will be submitted to a future medical conference and for publication.
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