Results of STRUCTURE study show romosozumab superior to teriparatide in change of BMD inpostmenopaUsal women with osteoporosis- Amgen + UCB

April 2016-Amgen and UCB announced detailed Phase III results showing the investigational agent romosozumab demonstrated a statistically significant increase in hip bone mineral density (BMD) and strength compared with teriparatide (Forteo) in postmenopausal women with osteoporosis transitioning from bisphosphonate treatment. The data, from the randomized, open-label, international, multi-center STRUCTURE study (STudy evaluating effect of RomosozUmab Compared with Teriparatide in postmenopaUsal women with osteoporosis at high risk for fracture pReviously treated with bisphosphonatE therapy), were presented during an oral session at ENDO 2016, the Endocrine Society's 98th Annual Meeting & Expo in Boston.

The trial included 436 women, averaging 72 years of age, with postmenopausal osteoporosis, a history of non-vertebral fracture after the age of 50, or vertebral fracture and treatment with bisphosphonate therapy for a minimum of three years prior to transitioning to romosozumab or teriparatide therapy. The women were randomly assigned to receive either subcutaneous romosozumab 210 mg once monthly (n=218) or subcutaneous teriparatide 20 mcg daily for 12 months (n=218). The results showed that the percent change from baseline in BMD at the total hip through month 12 (the primary endpoint, an average of the percent change from baseline at month six and 12), was significantly greater with romosozumab compared with teriparatide: 2.6 percent versus -0.6 percent, respectively (p<0.0001), for a mean difference between the two groups of 3.2 percent (p<0.0001). The measurement was based on the standard method of dual-energy x-ray absorptiometry (DXA).

For the secondary endpoints, patients treated with romosozumab had significantly larger increases from baseline in BMD and strength compared with those taking teriparatide, with mean differences ranging from 3.1 percent to 4.6 percent (all p-values <0.0001).The overall incidence of adverse events was generally balanced between the two study arms. Incidence of all adverse events in patients treated with romosozumab was 75.2 percent compared to 69.2 percent with teriparatide.