Yearly infusions of the bone-strengthening agent zoledronic acid in elderly people who have suffered a hip fracture reduced deaths by 28 percent and new fractures by 35 percent over a two-year period - the first time any treatment has been shown to reduce mortality in such patients.
Researchers reported in May that the drug, sold under the brand name Reclast by Novartis, significantly reduced the incidence of fractures in patients with osteoporosis. But the new trial is the first to study people who already have suffered a fracture, said Dr. Dennis Black of the University of California, San Francisco, who was not involved in the study.
The results were "powerful and compelling," and the study "clearly establishes the need for pharmacologic intervention in patients who fracture a hip," wrote pharmacologists Karim Anton Calis and Frank Pucino of the National Institutes of Health in an editorial to accompany the paper in the Nov. 1 issue of New England Journal of Medicine.
The report was published online Monday to coincide with presentation of the results at a Honolulu meeting of the American Society of Bone and Mineral Research.
About 300,000 Americans are hospitalized yearly with hip fractures, and the outcome can be devastating. As many as 25 percent of the victims die within the first year after their injury, the survivors' risk of subsequent fractures is as much as 10 times higher than normal, and the majority of the victims remain confined to a nursing home for the rest of their lives.
Dr. Kenneth W. Lyles of Duke University Medical Center and his colleagues studied 2,127 men and women - mostly women - with a mean age of 74 who had suffered a hip fracture without other major trauma. Half were given a 15-minute infusion of zoledronic acid within 90 days of their injury and again at the end of a year, and the rest were given a placebo.
Those who received the drug were unwilling or unable to take oral bone-strengthening agents in the same class, such as Fosamax, Actonel or Boniva. All are bisphosphonates, which bind to cells in bones and prevent them from breaking down bone tissue.
The oral drugs, which are given weekly, monthly or every three months, can cause nausea and erosion of the esophagus. They must be taken on an empty stomach with a full glass of water and the patient must remain upright for a full 30 minutes after taking them.
The infusion of zoledronic acid is easier in elderly patients and requires fewer trips to the doctor.