benefits of prolia®
Treatment with Prolia® (denosumab) results in increased bone density, reducing the risk of fractures
The efficacy of Prolia® (denosumab) has been demonstrated to improve bone strength and reduce the risk of osteoporotic fractures.
Prolia® was shown to increase bone density in all evaluated sites in postmenopausal women at 1, 2 and 3 years. Following three years of Prolia® (denosumab) treatment, 2,3% of women had had a new vertebral fracture compared with 7.2% of the women receiving placebo.
Risk reduction for hip fracture during the study period (40 %) in this study was similar to what has previously been demonstrated for zoledronic acid.
Similarly, in treatment of men with osteoporosis, Prolia® (denosumab) increased bone density by 5.7% after one year of treatment compared to 0.9% in patients receiving placebo. In patients on hormone ablation treatment for prostate cancer, Prolia® patients had an increased bone density in the lumbar spine that was 7% higher than the control group after two years.
For treatment of osteoporosis in postmenopausal women at increased risk of fractures, the pivotal clinical study on the efficacy of Prolia® (denosumab) treatment has been adequate in size and design. The efficacy on BMD increases were better than what has been earlier demonstrated for Oral BP approved for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
For treatment of bone loss associated with hormone ablation in men with prostate cancer, efficacy was clearly shown as vertebral fracture incidence vs placebo reduction and this effect is clinically relevant.