Romosozumab: Additional Phase III data

Additional data from the open-label, international Phase III STRUCTURE trial in 436 postmenopausal women with osteoporosis at high risk for fracture who were previously treated with bisphosphonate therapy showed that once-monthly 210 mg subcutaneous romosozumab led to a 2.6% increase in BMD as measured by DXA scanning at the total hip from baseline to 12 months, the primary endpoint, vs. a 0.6% reduction for once-daily 20 ug subcutaneous Forteo teriparatide (p<0.0001). Romosozumab also met the secondary endpoints of improving BMD at the femoral neck (3.2% vs. -0.2%) and total hip (9.8% vs. 5.4%) from baseline to 12 months and at the total hip (2.3% vs. -0.8%), femoral neck (2.1% vs. -1.1%) and lumbar spine (7.2% vs. 3.5%) from baseline to 6 months vs. Forteo (p<0.0001 for all). Data were presented at the Endocrine Society meeting in Boston. Amgen previously reported that romosozumab met the primary endpoint (see BioCentury, Sep. 7, 2015). ...