Results from a Phase 4 study of Amgen’s Prolia (denosumab) showed that the drug achieved greater gains in bone mineral density (BMD) than intravenous bisphosphonate zoledronic acid in postmenopausal women with osteoporosis following previous treatment with oral bisphosphonates.
“Despite the availability of newer therapies like denosumab, bisphosphonates are commonly used first-line to treat osteoporosis,” said lead investigator Paul Miller, M.D., medical director of the Colorado Center for Bone Research, Lakewood, Colo. “Our findings showed that denosumab provides significantly greater bone mineral density increases than zoledronic acid.”
Patients treated with denosumab had significantly greater improvements in primary and secondary endpoints in the study
The 12-month study included 643 women 55 years or older who had postmenopausal osteoporosis and had been taking oral bisphosphonate therapy for two or more years. The women were randomized 1:1 to receive either subcutaneous denosumab every six months plus intravenous placebo once yearly or intravenous zoledronic acid once yearly plus subcutaneous placebo every six months. The change from baseline in lumbar spine BMD at 12 months – the primary endpoint – in the denosumab group was significantly greater than that in the zoledronic acid group.
The denosumab group also had significantly greater improvements than the zoledronic acid group in secondary and exploratory study endpoints, including BMD changes in the total hip, femoral neck, and 1/3 radius.
“These findings add to the evidence supporting Prolia as an important therapeutic option for women with postmenopausal osteoporosis, especially those who have failed bisphosphonate treatment,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Our continued research in this innovative antiresorptive reinforces Amgen’s commitment to bone biology and understanding the value Prolia brings to treating osteoporosis in postmenopausal women at high risk for fracture.”
