Novartis Bone Drug Curbs Repeat Hip Fractures

In a study that could change the way hip fractures are treated, doctors have discovered that giving the Novartis osteoporosis drug Reclast can prevent later fractures and helps patients live longer.

The 300,000 hip fractures that occur each year in the U.S. are a major source of death and disability.

About one third of people who break a hip are dead within two years and patients who break a hip once are up to 10 times more likely to develop a second break there.

The study, financed by the Swiss drug maker , found that the once-a-year injections given to 1,065 volunteers reduced the risk of any subsequent fracture by 35%, compared to the risk for the 1,062 patients given a placebo. The fracture rate was 8.6% with Reclast and 13.9% for placebo.

In addition the drug, known generically as zoledronic acid, reduced the death rate by 28% over two years, said Dr. Kenneth Lyles of Duke University Medical Center in North Carolina and his colleagues.

Overall, 9.6% died in the Reclast group versus 13.3% in the placebo group if the drug was given within 90 days of the first hip fracture. The benefits were so pronounced, the study was halted early.

Lyles said he and his team were surprised that the treatment produced that he called "the death benefit." "We thought we'd change fracture rates," he said in a telephone interview.

The fact that fewer Reclast patients developed new fractures "doesn't explain it. There's something else going on here, so we've got to study it. It's a nice problem to have," said Lyles, who has patents on techniques for prevent secondary fractures.

The 15-minute infusion costs about $1,041, he said.

Striking Results

The study, published online by the New England Journal of Medicine, is the first in which an osteoporosis drug has been tested in people who have already broken a hip.

The results "appear both powerful and compelling," said Karim Anton Calis and Frank Pucino of the National Institutes of Health, who wrote a commentary. "The reduction in fracture incidence and death was striking and clearly establishes the need for pharmacologic intervention in patients who fracture a hip," they wrote.

"Very few patients get treatment for osteoporosis after fracturing a hip, so we believe that using a drug like zoledronic acid can be instrumental in reducing the frailty so common in the elderly," Lyles said in a statement.

Lyles said people often think nothing can be done once a fracture has occurred. In addition, patients often give up on osteoporosis drugs that must be taken daily or weekly.

Calis and Pucino said there is no reason to believe that similar drugs, known as bisphosphonates, will not have the same effect if given aggressively.

Reclast, sold outside the United States as Aclasta, was approved in August by the U.S. Food and Drug Administration for osteoporosis and is awaiting approval from the European Union.

In May, another Reclast study raised the possibility that the drug might spark an abnormal heart rhythm known as atrial fibrillation, which can increase the risk of stroke.

But the new study found no evidence of that. The risk of any serious heart rhythm abnormality was 2.3% among drug patients and 3.7% for those receiving a placebo.