experimental drug denosumab can increase bone-mineral density and help prevent fractures when women with osteoporosis take it only twice a year, according to the results of a recent trial.
The study involved 412 postmenopausal women. During the trial, the participants were given denosumab, a placebo or
Fosamax, which is already on the market for treating osteoporosis.
Researchers found that denosumab appeared to be at least as effective as Fosamax, and further studies are currently under way. The study was meant to examine denosumab's safety and effectiveness after 12 months.
Having to get the treatment only two times annually could be a crucial plus for denosumab, considering that existing osteoporosis drugs are taken much more often. Fosamax and
Procter & Gamble's
Actonel are taken once a week. Boniva from
is administered once a month.
With osteoporosis, bones become fragile and more likely to break. The condition, if it isn't treated, can progress painlessly until a bone breaks. Breaks typically occur in the hip, spine and wrist, but any bone can be affected. Bone-mineral density is often used as an indicator of the likelihood of a fracture, so increasing it would be expected to lower the odds of a break.
Those most likely to develop osteoporosis are Caucasian or Asian women who are going through or are past menopause. Other risk factors include estrogen deficiency as a result of menopause, a low calcium intake througout one's life and a shortage of vitamin D.
According to the National Osteoporosis Foundation, 10 million U.S. residents, including 8 million women, already have the disease. Nearly 34 million more have low bone mass, increasing the chance they'll have osteoporosis.
Phase III trials of denosumab will study bone fractures over the course of three years in women with low bone density who are taking the Amgen drug plus calcium or calcium alone. Phase III studies are required before a drug is submitted for Food and Drug Administration marketing approval.
The study, published in Thursday's issue of the
New England Journal of Medicine
, was sponsored by Amgen.
Shares of the biotech giant dipped 43 cents to $74.65.