Study: Drug reduces death after hip breaks

Older people who suffered hip fractures had a lower death rate and fewer new breaks when given annual intravenous doses of a drug that reduces bone loss, a Duke University researcher announced Monday.

The study, the first of its kind to show a reduced death rate from hip fractures, could have wide-ranging benefits. Hip fractures, the vast majority caused by the bone-thinning disease osteoporosis, are often deadly to older people, claiming the lives of one in five of those injured within a year. In North Carolina, 21 people over 65 are hospitalized each day with hip fractures, and 13 are discharged straight to a skilled nursing facility.

As a result, hip fracture hospitalizations cost almost $200 million annually in North Carolina, according to new state health statistics.

The trial, led by Duke University Medical Center geriatrician Dr. Kenneth W. Lyles, studied whether more than 2,000 post-fracture patients would show lower rates of renewed fractures when taking an annual infusion of zoledronic acid. The drug is manufactured by study sponsor Novartis Pharma under the trade name Reclast.

Lyles announced the results Monday at the annual meeting in Honolulu of the American Society of Bone and Mineral Research. They were also published Monday in the online edition of The New England Journal of Medicine.

Patients getting the infusion of Reclast had 35 percent fewer fractures than a control group. That wasn't the only noteworthy finding.

"We cut death by 28 percent," Lyles said in an interview.

"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."

Debilitating fractures

Garner resident Doris Ellington, 83, said Monday she would welcome medication that could reduce chances of a new fracture. She broke her left hip in a Sept. 5 fall and has been recuperating at WakeMed in Raleigh.

Ellington wasn't in the clinical trials, which included patients in North and South American and Europe. She said she'd like a "bucket full" of the medicine, but instead will build her herself back up with old-fashioned hard work, so she can get back to her home and garden.

"I'm going to just keep working at it," she said.

Her physical therapy has been strenuous. Recovery after a hip fracture focuses on increasing strength, flexibility and mobility to get patients back to routine tasks and prevent falls, experts say. The fractures are debilitating to older people and often require surgery. Risks after a fracture include reduced mobility, lung problems and stroke, according to the National Osteoporosis Foundation.

"When you ask elderly patients, they are not so much afraid of dying, they are afraid of becoming dependent," said Dr. Irene Hamrick, associate professor and geriatric fellowship director at East Carolina University.

The Food and Drug Administration gave approval last month to zoledronic acid, the drug used in the trial, as a treatment for osteoporosis in women past menopause. Lyles said the study patients who did not get the drug got large doses of Vitamin D to combat osteoporosis. No patients received other drugs, such as Fosamax, which are in the same class as Reclast but are administered in another form.

Fewer deaths

Hamrick, the East Carolina University doctor, said results might have been similar had a group of patients been given Fosamax, or another osteoporosis drug in the bisphosphonate class that includes Reclast.

"I think any strong osteoporosis drug ... that has hip-fracture data would reduce mortality," Hamrick said.

Said Lyles, "That is unknowable at this point."

He said adding another group of subjects to test Reclast against another drug in the same class would have made the sample size so large that it would been very difficult to recruit enough subjects.

The research was funded by Novartis Pharma, the manufacturer of zoledronic acid. Lyles got both support for the trials and consulting fees from Novartis; he is also an inventor on two use patent applications for Reclast.

"What we want everyone to understand is that we designed the trial, we collected the data and ... Novartis did the data analysis," Lyles said. However, he said, a group of independent researchers at the University of California at San Francisco independently reproduced the results using raw data.

Past side effects of zoledronic acid have included abnormal heart rhythms and a rare jaw condition called osteonecrosis, but neither emerged as a risk in the recent trials, Lyles said.