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.
"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."
"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.
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.
AILSA CHANG, HOST:
A drug commonly used to treat the bone-thinning disease osteoporosis could protect many more older women against bone fractures. That's according to a big new study published today by the New England Journal of Medicine. NPR health correspondent Rob Stein has the details.
ROB STEIN, BYLINE: As we age, our bones tend to get thinner and thinner. And Ian Reid, of the University of Auckland, says millions of older people break a hip, a spine or some other bone. And it's often the beginning of the end.
IAN REID: In a frail older person, having a fracture can be the final straw that interferes with them being able to live independently and moves them into an institution.
STEIN: And the problem's just getting worse.
REID: What's happening at the present time is we are all living longer. Our population is progressively aging. And so fractures in older people is becoming a very major issue.
STEIN: People diagnosed with the bone-thinning disease osteoporosis can take drugs to prevent fractures. But there's been a big debate about people with less frail bones.
REID: In fact, most of the fractures that occur in older people occur in the much larger number of people who have moderate bone loss.
STEIN: So Reid and his colleagues tested a drug long used to treat osteoporosis on 2,000 women 65 and older with just the early stages of bone loss, a condition known as osteopenia. For six years, half got infusions of the drug. Half got a placebo.
REID: We saw about a one-third reduction in total numbers of fractures and about a 50 percent reduction in spine fractures.
STEIN: And no sign of any serious side effects - in fact, the women getting the drug were less likely to suffer heart attacks, get cancer, maybe even die.
REID: So I think what this means is that we can broaden the group of people to whom we can offer these medications. And therefore, we can reduce the total number of fractures occurring across the community more effectively.
STEIN: Other experts agree.
ETHEL SIRIS: This is an extremely important paper.
STEIN: That's Ethel Siris at Columbia.
SIRIS: The reason this is so important is that we have been uncertain what to do with the great number of people, primarily women over the age of 60-65, who have osteopenia. You now know you have a drug that you can use that has been shown to work in such patients. It's a big deal.
STEIN: A lot of doctors and patients got scared away from these drugs because of reports they could actually cause hip fractures and unusual jaw problems. But Michael Econs, of the American Society for Bone and Mineral Research, says the new results should make people rethink that.
MICHAEL ECONS: We are overly worried about exceedingly rare side effects and under worried about common things like fractures. I think you have to start looking at where the big picture is.
STEIN: But others are more cautious.
ROBERT MCLEAN: This one study is helpful. And it's suggestive. But one study, in and of itself, does not necessarily mean truth.
STEIN: That's Robert McLean from Yale. He's president-elect of the American College of Physicians.
MCLEAN: We're not going to reconvene and immediately change the guidelines.
STEIN: But everyone agrees that older people should talk with their doctors about the new study to see if taking a drug to cut the risk of breaking a bone makes sense for them or not. Rob Stein, NPR News.
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