Amgen announced results from a 7-year, single-arm, open-label extension of the 3-year randomized, double-blind, placebo-controlled, multi-center, international Phase 3 FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis every six Months) Study.

The final analysis showed that treatment with Prolia (denosumab) for up to 10 years resulted in consistent overall incidence of adverse events and serious adverse events throughout the study duration with a low fracture incidence. Postmenopausal women with osteoporosis taking Prolia continued to show increase in bone mineral density (BMD) over 10 years.

The FREEDOM fracture study enrolled 7,808 women with postmenopausal osteoporosis. Patients were randomized to Prolia 60mg or placebo subcutaneously every 6 months for 3 years, after which they could volunteer to enter a 7-year extension study. In the extension, all patients received open-label Prolia every 6 months and the long-term group received up to 10 years of Prolia. A total of 2,626 women completed the extension study.

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Study results showed that patients treated for 10 years achieved an average cumulative 10-year gain in BMD of 21.7% at the lumbar spine and 9.2% at the total hip vs. baseline in the Phase 3 fracture study. Also, researchers noted that overall rates of adverse events and serious adverse events were consistent with results reported in the extension study.

Prolia is a osteoclast inhibitor (RANKL inhibitor) currently indicated in postmenopausal women with osteoporosis: at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other therapy; to reduce incidence of vertebral, nonvertebral, and hip fractures; to increase bone mass in men with osteoporosis at high risk for fracture; to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; to reduce incidence of vertebral fractures; and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

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