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Osteoporosis drug found to cut risk of death after broken hip

Simple treatment has long been urged, ignored

A simple treatment for osteoporosis can cut the risk of death following a broken hip by 28 percent, according to a study released last night that confirms a long-recommended but often ignored treatment.

In hip fracture patients, a yearly dose of a new osteoporosis drug, zoledronic acid, reduced subsequent broken bones by 35 percent, and had the surprising benefit of improving survival, according to the study published online by the New England Journal of Medicine.

Other research has shown as many as one in seven hip-fracture patients break a second hip and many more suffer other fractures, in part because they don't get treated for osteoporosis. Those additional fractures, and other physical and mental complications, lead to remarkably high death rates among hip fracture patients 65 and older. Each year, about 300,000 patients that age fracture hips, most through simple falls.

Research commissioned by the Globe and conducted by the University of Maryland School of Medicine last year found that 29 percent of older people who break a hip die within a year, up from 24 percent in the late 1980s. Improved surgical techniques and prevention of many serious complications have helped improve outcomes, but up until now researchers have been hard-pressed to identify new proven ways to reduce the death rate.

"The reduction in fracture incidence and death was striking and clearly establishes the need for a pharmacologic intervention in patients who fracture a hip," wrote Karim Anton Calis, director of the drug information service at the National Institutes of Health, in an editorial that accompanied the zoledronic acid study.

"It will increase public awareness about the need for treating patients with a bone-protective medication, in addition to calcium and vitamin D," Calis, a pharmacist, added in a telephone interview. While zoledronic acid is the first to be shown to reduce the death rate, he said, other drugs could turn out to be as effective.

There are a handful of drugs for osteoporosis on the market, most taken weekly or monthly in pill form. Zoledronic acid is administered by intravenous infusion that takes 15 to 20 minutes.

The new study was sponsored by Novartis, the company that makes the drug, marketed under the brand name Reclast. The lead researcher, Dr. Kenneth Lyles of Duke University Medical Center, receives grants and speaking fees from Novartis and is an inventor on two patent applications for use of the drug. Because of the conflicts of interest, Lyles said he engaged statisticians at the University of California at San Francisco to provide an independent review of the data. Dr. Edward Marcantonio, a director of research at Beth Israel Deaconess Medical Center who was not involved in the study, yesterday called it "rigorously performed" and impressive.

The researchers randomly assigned more than 2,100 patients who had fractured a hip to get a yearly dose of zoledronic acid or a dummy drug, and then followed their health for an average of nearly two years. There were 139 subsequent fractures in those who took the placebo drug, compared with 92 in the zoledronic acid group, a reduction of 35 percent - and the effect the researchers had hoped for, Lyles said. Researchers were surprised to also find the reduction in mortality. A total of 101 patients who got the drug died, as did 141 who got the placebo.

"The change in death rate cannot fully be explained by the reduction in fractures," said Lyles, a geriatrician, adding that researchers will have to study the data further to determine what other factors may have been involved.

The impact is particularly surprising because the individuals studied were younger and healthier than typical hip fracture patients, and even those getting a placebo had lower-than-usual rates of second fractures and death. All patients in the study also got vitamin D and calcium.

There were few serious side effects. But Calis said additional studies are needed.

While the study shows that preventing additional fractures is important, Marcantonio said researchers need to pursue other ways to reduce the death rate, including improvements in surgical and medical follow-up.

"This is just one approach," said Marcantonio, a geriatrician.

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