Wider Use Of Osteoporosis Drug Could Prevent Bone Fractures In More Elderly Women
Editor's note: This story was updated on Oct. 23, to add conflict-of-interest disclosures for the lead author of the research study.
A large study has produced strong evidence that a drug commonly used to treat the bone-thinning disease osteoporosis could safely prevent fractures in elderly women who have bones that aren't as weak.
The study of 2,000 women age 65 and older at earlier stages of bone loss — a condition known as osteopenia — found the drug zoledronate reduced by about one-third the risk they would suffer a break.
"This is an extremely important paper," says Dr. Ethel Siris, a Columbia University medical professor who specializes in thinning bones and wasn't involved in the study. "We now know that we have a therapy that has been shown to be highly effective."
The findings were published Monday in the New England Journal of Medicine and presented at a meeting of the American Society for Bone and Mineral Research in Montreal.
"This could prevent a lot of fractures," says Siris, who is on the board of trustees of the National Osteoporosis Foundation. "And preventing fractures in people in this age range not only prevents a lot of suffering but also saves a lot of money."
The results indicate that doctors should consider millions of additional women as candidates for the treatment, which is now only routinely recommended for women whose bones have thinned so much that they have been formally diagnosed with osteoporosis. ASBMR says a treatment with zoledronate costs between $300 and $500.
"I think it's a breakthrough," says Clifford Rosen, an endocrinologist and physician at the Maine Medical Center, who wrote an editorial accompanying the study. "We need to at least allow people to think about this as another option they could consider. This may be the future in terms of treatment."
But others remain cautious.
The new results are "suggestive and helpful," says Robert McClean, a rheumatologist at the Yale School of Medicine who is the president-elect of the American College of Physicians. But "one study, in and of itself, does not necessarily mean truth," McClean says. "We're not going to reconvene and immediately change the guidelines."
As people age, their bones tend to thin, which puts them at risk for fractures. Broken bones are a major problem among the elderly and have been rising as the population gets older. Broken hips, spines and other bones often lead to a cascade of increasingly life-threatening health problems among the elderly.
A class of drugs known as bisphosphonates has long been used to reduce the risk of fractures among people with osteoporosis, a condition of relatively severe bone thinning.
These drugs were once used much more widely. But doctors and patients became concerned as reports of rare and sometimes severe complications surfaced, including hip fractures and jaw problems.
And while National Osteoporosis Foundation guidelines recommend drug treatment for women at risk for fractures, the American College of Physicians' guidelines say current evidence of the benefit of drugs for osteopenia is "limited."
In the new study, Dr. Ian Reid of the University of Auckland and his colleagues gave women with osteopenia 15-minute infusions of zoledronate or a placebo once every 18 months.
(In a supplement to the New England Journal of Medicine study, Reid reports receiving speaking and consulting fees from four drug companies in the preceding 36 months, including Novartis, which makes a brand-name formulation of zoledronate. The study itself wasn't funded by Novartis, according to the main article. Novartis did supply the drug for the study.)
After six years, the women who got zoledronate were about 30 percent less likely to have experienced any fracture and about 50 percent less likely to have experienced a fracture of their spine, the researchers reported.
"I think we've provided an important plank of evidence that can guide our clinical practice going forward," Reid says.
Dr. Michael Econs, a professor of medicine at Indiana School of Medicine who serves as the president of the ASBMR, agrees.
"What this paper does is make us think a little more about treating people who we might not have treated before or we thought might be on the line," Econs says. "We are overly worried about exceedingly rare side effects and underworried about common things like fracture. You have to start looking at where the big picture is."
There were no indications of any serious side effects. In fact, the women who got the drug appeared to be less likely to die overall than women who received the placebo, though that finding was not statistically significant. There were, however, statistically significant decreases in heart attacks and cancers among the women getting the drug.
"That's something we don't have clear explanation for," Reid says.
Although the study involved only women, Reid says the drugs may also benefit men.
It's unclear whether other bisphosphonates would be equally beneficial, though they may, Reid says.
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