Primary Endpoint Met in Study of Postmenopausal Women With Osteoporosis Transitioning From Bisphosphonate Treatment
Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today 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). The study (NCT01796301) 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.
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 (210 mg monthly) or subcutaneous teriparatide (20 mcg daily) through to month 12.
The overall subject incidence of adverse events was generally balanced between arms. Adverse events in patients treated with romosozumab were similar to those previously reported and no new safety signals were detected. Adverse events reported in the romosozumab arm in more than five percent of patients were nasopharyngitis, arthralgia, back pain, headache and fall.
Further analysis of the Phase 3 STRUCTURE study results are ongoing and will be submitted to a future medical conference and for publication.