Ten year follow up of FREEDOM study of Prolia (denosumab) for treatment of osteoporosis- Amgen

Amgen announced results from a seven-year, single-arm, open-label extension of the three year randomized, double-blind, placebo-controlled, multicenter, international Phase III Fracture Reduction Evaluation of Denosumab in Osteoporosis every six Months (FREEDOM) study. In this final analysis, treatment with Prolia (denosumab) for up to 10 years showed that the overall incidence of adverse events (AEs) and serious AEs remained consistent over the duration of the study with a low fracture incidence. In addition, postmenopausal women with osteoporosis on denosumab continued to show gains in bone mineral density (BMD) over 10 years.

The findings were presented during a late-breaking oral presentation session at the American Society for Bone and Mineral Research (ASBMR) 2015 Annual Meeting in Seattle.

Subjects treated for 10 years with denosumab achieved an average cumulative 10-year gain in BMD of 21.7% at the lumbar spine and 9.2% at the total hip, compared to baseline in the pivotal Phase III fracture study. Overall rates of AEs and serious AEs were consistent with data reported previously in the extension study. Yearly rates of new vertebral and nonvertebral fractures remained low. During the seven years of the extension, 13 oral events were confirmed as osteonecrosis of the jaw (ONJ) and two events were confirmed as atypical femoral fracture by independent adjudication committees. No atypical femoral fractures or ONJ cases were reported in the original three-year core study.