Once-a-Year Bone Drug Lowers Fracture Risk

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By Amanda Gardner
HealthDay Reporter
Tuesday, September 18, 2007; 12:00 AM

TUESDAY, Sept. 18 (HealthDay News) -- One annual injection of the drug zoledronic acid (Reclast) not only reduces the number of new hip fractures for older users, it can also save their lives.

So finds the first trial to show an improvement in mortality for the drug. Previous studies had shown a reduced risk of fracture and improved bone density in patients with osteoporosis but not such a boost in outcomes.

"We changed the fracture rate and, when we analyzed the data, we had a significant mortality reduction. We never dreamed we'd have that," said study author Dr. Kenneth W. Lyles. He spoke from Honolulu, where he is presenting the data at the American Society of Bone and Mineral Research annual meeting.

The study was released early by theNew England Journal of Medicineto coincide with the presentation.

Lyles is professor of medicine and vice chairman for clinical research in the department of medicine at Duke University Medical Center in Durham, N.C.

Novartis Pharma, which manufactures Reclast, funded the study. Lyles also has ties with the company.

"This is the first test of using this to prevent further fractures in elderly patients, and the reason that is a big deal is people weren't sure if zoledronic acid inhibited osteoclasts [cells] which are needed for repair" of the initial fracture, explained Paul Brandt, an associate professor of neuroscience and experimental therapeutics with the Texas A&M Health Science Center College of Medicine.

"This study shows that it doesn't interfere with that process and does give the beneficial effect of reducing further fracture rates," said Brandt, who was not involved in the trial.

An estimated 345,000 Americans are hospitalized each year with a hip fracture, and as the Baby Boomers age, that number is certain to grow.

According to an accompanying editorial, 36 percent of patients who have sustained a hip fracture will die within two years of the incident. These individuals are also five to 10 times more likely to suffer another hip fracture.

Many such fractures are the result of osteoporosis, a disease which primarily affects women in their postmenopausal years. With this disease, bones thin out and become more fragile, causing them to break more easily. Fracture can often result in severe disability, even death.

Reclast was approved in August by the U.S. Food and Drug Administration to treat osteoporosis in postmenopausal women.


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