Results from the pivotal FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every six Months) study in 7,868 women with postmenopausal osteoporosis showed that women receiving a subcutaneous injection of Prolia twice-yearly experienced a 68 percent reduction in the risk of suffering a new vertebral (spine) fracture compared to those receiving placebo, as well as a 40 percent reduction in the risk of suffering a hip fracture and a 20 percent reduction in the risk of suffering a nonvertebral fracture. Results from the pivotal Hormone AbLation Therapy study in 1,468 men undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer showed that patients treated with Prolia experienced a 62 percent reduction in the risk of suffering a new vertebral fracture with Prolia compared to placebo at 36 months, with significant reduction observed as early as month 12. In both pivotal studies, the incidence and types of adverse reactions observed with Prolia were similar to those seen in patients taking a placebo. The most common adverse reactions in both the Prolia and placebo groups were arthralgia, back pain, hypertension, nasopharyngitis, constipation and pain in an extremity. Serious adverse reactions of skin infections, predominantly cellulitis, were reported more commonly in the Prolia group (0.4 percent vs. <0.1 percent) in postmenopausal osteoporosis studies. In breast and prostate cancer studies, serious adverse reactions were similar in the Prolia and placebo groups (0.6 percent vs. 0.6 percent).

Prolia is also under regulatory review in the United States (U.S.), Switzerland, Australia and Canada for the treatment and prevention of postmenopausal osteoporosis and for the treatment of bone loss in patients undergoing hormone ablation therapy for breast or prostate cancer.