Word: denosumab
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...increase in number as people age. But a new compound under review by the FDA tackles the problem in a different way ? by curbing the formation of the bone-gnawing cells. That tilts the balance in favor of bone-building. In two studies published in August, the experimental compound denosumab was shown to reduce the risk of fractures in postmenopausal women as well as men being treated for prostate cancer, the two largest patient populations at risk for bone loss. What's not clear, however, is how the new drug, if approved, would compare with existing osteoporosis drugs like Fosamax...
...clear how denosumab, should it win approval, would fit into the anti-osteoporosis market for treating postmenopausal women. Among these patients, the study suggests, the experimental compound would be slightly more effective at reducing fractures than the bisphosphonate drugs Fosamax (alendronate) and Boniva (ibandronate), but no better than Reclast (zoledronic acid), the once-a-year solution that doctors administer intravenously...
...much impact this would have on patient care remains to be seen," says Dr. Sundeep Khosla, a professor of medicine at the Mayo Clinic, who wrote an editorial accompanying the two studies in the Journal. But because denosumab did not result in any serious side effects, it has the potential of becoming a safer alternative, should its current profile hold up in additional studies...
...people age. While the body continually destroys and replaces bone tissue throughout life, the destruction eventually begins to overtake the construction, and the result in older age is a patchier, weaker type of bone that is more prone to breaking. While bisphosphonates block the activity of bone-destroying cells, denosumab prevents new ones from forming altogether. The end result is a tipping of the bone balance away from bone destruction and toward bone formation. Early studies in mice at Amgen, the company that developed denosumab, showed that animals given higher amounts of this compound developed thicker, more robust bone...
...Khosla notes that neither the bisphosphonates nor denosumab actually causes the creation of new bone, which would be the ultimate goal of any osteoporosis treatment. The increases in bone-mineral density seen in the Journal studies is primarily due to minerals filling in the gaps left in the wake of bone destruction, he says. "In my mind, the dramatic changes will be seen with the anabolic agents," he says. "They hold the potential for completely curing the disease, reversing bone loss so you effectively are not osteoporotic any more...