Amgen's Prolia provides greater bone mineral density gains than zoledronic acid

US biotech major Amgen (Nasdaq: AMGN) has announced Phase IV data showing Prolia (denosumab) achieved greater gains in bone mineral density than the intravenous bisphosphonate zoledronic acid in post-menopausal women with osteoporosis following previous treatment with oral bisphosphonates.

Paul Miller, lead investigator of the study, said: "Despite the availability of newer therapies like denosumab, bisphosphonates are commonly used first-line to treat osteoporosis. Our findings showed that denosumab provides significantly greater bone mineral density increases than zoledronic acid."

The study took place over 12 months and included 643 women aged 55 years and older who had post-menopausal 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 and intravenous placebo once a year, or intravenous zoledronic acid once a year plus subcutaneous placebo every six months. The change from baseline in lumbar spine BMD at 12 months, which was the primary endpoint, was significantly greater in the denosumab group than in the zoledronic acid group. No new safety signals were identified.