In women with osteoporosis, the experimental bone drug denosumab reduced the risk of spinal fractures by 68 percent, the risk of hip fractures by 40 percent, and the risk of all fractures outside the spine by 20 percent, according to a study released Tuesday by drug maker Amgen.
The study of 7,800 postmenopausal women found that 2.3 percent of those who took the drug suffered a vertebral fracture, compared with 7.2 percent of those who took a placebo. That 68 percent relative risk reduction compares favorably with the 40 to 50 percent reductions achieved in clinical trials by drugs currently used to treat osteoporosis, The New York Times reported.
The 40 percent reduced risk of hip fracture noted in women who took denosumab is as good or better than that results seen with other drugs.
However, the study did find that 4.3 percent of women who took denosumab suffered serious infections, compared with 3.4 percent of those who took the placebo. While not statistically significant, the increased risk of infection could concern government regulators, The Times reported.
The study was presented at the annual meeting of the American Society for Bone and Mineral Research. It's expected Amgen will apply for U.S. Food and Drug Administration approval of denosumab by early next year.