In this pivotal, three-year, international, Phase III study of approximately 7,800 women with osteoporosis, patients were randomized to receive either denosumab, given by subcutaneous injection once every six months, or placebo injections.
For the primary endpoint, treatment with denosumab resulted in a statistically significant reduction in the incidence of new vertebral fractures compared with placebo treatment.
In addition, women receiving denosumab experienced a statistically significant reduction in the incidence of new non-vertebral and hip fractures (each secondary endpoints) compared with those receiving placebo.
Roger Perlmutter, executive vice president of R&D at Amgen, said: “This long-awaited study demonstrated that denosumab treatment both increased bone mass and reduced the risk of skeletal fractures in women with postmenopausal osteoporosis.”