The latest breakthrough in Osteoporosis treatment is the new experimental drug – romosozumab. According to researchers, it prompts the body to rebuild bone and could potentially strengthen the skeleton against fractures.
Romosozumab frees the body’s ability to stimulate bone production by blocking biochemical signals that naturally inhibit bone formation, explains Dr. Michael McClung, founding director of the Oregon Osteoporosis Center in Portland, Oregon. The treatment is one-and-a-half to three times more effective than current osteoporosis drugs in rebuilding bone density at the lumbar spine, according to clinical trial results McClung and his colleagues reported in the Jan.1 online edition of the New England Journal of Medicine.
Sclerostin and bone growth
However, research is needed before romosozumab can be approved to treat osteoporosis. The new drug uses an antibody to block the function of sclerostin, a protein the body produces to naturally inhibit bone growth. Without sclerostin, overactive bone growth might clamp off nerves or end up fusing the spinal column, says Dr. Robert Recker, president of the National Osteoporosis Foundation and director of the Osteoporosis Research Center at Creighton University in Omaha, Nebraska.
But sclerostin also prevents people with osteoporosis from building additional bone density to replace the bone that has been lost. The antibody romosozumab binds to sclerostin and prevents its signal, which allows pro-bone-growth signals to proceed uninterrupted, the researchers explained.
Results of the study
The phase 2 clinical trial involved more than 400 postmenopausal women aged 55 to 85 who had osteopenia, which is low bone mass that is not low enough to be classified as osteoporosis. They were randomly assigned to receive one of four treatments for a year: romosozumab; a placebo; or one of two current osteoporosis medications.
Results showed that romosozumab increased bone mineral density in the spine by 11.3 percent during the study period, compared with a 7.1 percent increase with teriparatide (Forteo), a current osteoporosis treatment. The new drug also performed much better than alendronate (Fosamax), a bisphosphonate medication that increased spinal bone density by 4.1 percent.
Safe from side-effects
According to McClung, Romosozumab also appears to be safe, with no major side effects, though it is still several years from coming to market. Researchers have to prove to the U.S. Food and Drug Administration that it actually protects against bone fractures, which will require more research.
But onlookers are enthusiastic regarding the potential of romosozumab, as it is also self-regulating. It is expected that the antibody medication will prove safe because the bone-building signals that are left uninhibited by the drug will taper off naturally as the skeleton becomes better able to withstand weight loads and stresses.
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