Prolia denosumab: Extension study data

Data from 4,550 postmenopausal women with osteoporosis enrolled in the open-label extension of the 3-year, double-blind, international Phase III FREEDOM trial showed 60 mg subcutaneous Prolia every 6 months significantly increased bone mineral density (BMD) at the lumbar spine and at the total hip by 12.1% and 6.5%, respectively, from baseline to 48 months (p<0.0001 for both). At 60 months, Prolia every 6 months increased BMD at the lumbar spine and at the total hip by 13.7% and 7%, respectively, from baseline. In patients who received placebo for 3 years in the FREEDOM trial, Prolia every 6 months for 1 year significantly increased BMD at the lumbar spine and at the total hip by 6% and 1.7%, respectively, from baseline to 48 months (p<0.0001 for both). ...