A variation of a drug commonly given to cancer patients with bone damage appears to be an effective tool for preventing repeat hip fractures in elderly patients, according to a study in the New England Journal of Medicine.
The study results, which were to be presented yesterday in Hawaii, have potentially big implications because hip fractures are a common and debilitating injury for older people. Most of the 300,000 hip fractures each year in the U.S. are related to osteoporosis in older people, as well as falls, according to an editorial accompanying the study. Older people who fracture their hips are more likely to have second fractures, and repeat fractures are associated with increased risk of death.
The study found that elderly patients who fractured their hips and then received once-a-year infusions of Reclast, an osteoporosis drug, were less likely to suffer second fractures than those who received a placebo. The Reclast group also lived longer. The rate of new fractures in the Reclast group was 8.6%, compared with 13.9% in the placebo group. The risk of death was reduced by 28% in the Reclast group, where 101 people died, compared with 141 in the placebo group. The study tracked 2,127 patients for nearly two years. The average age of the study participants was 74.
The drug's maker, Novartis AG, which is based in Switzerland, says it plans to ask the U.S. Food and Drug Administration and regulatory agencies in other countries to expand the drug's label for its use in preventing repeat hip fractures.
In the accompanying editorial, pharmacists from the National Institutes of Health and the University of Maryland called the study results "powerful and compelling" and the reduction in fractures and deaths "striking." The study, they added, clearly establishes the need for hip-fracture patients to get treated with Reclast or another drug in that class.
Reclast is a bisphosphonate, a class of drug that includes Fosamax, which is made by Merck & Co. Reclast's active ingredient is zoledronic acid, which is the same active ingredient in Zometa, another drug from Novartis with sales of $1.3 billion last year. Zometa is given to cancer patients with bone damage. Zoledronic acid works by increasing bone mass.
Reclast was approved by the FDA this year to treat osteoporosis in women after menopause and Paget's disease, a bone disorder. The study results should provide a boost to Reclast sales, says Joseph Tooley, an analyst with A.G. Edwards in St. Louis. He said the drug should garner sales of close to $1 billion annually by 2011.
A potential area of concern will be the heavy influence of Novartis, which funded the study, helped design it and performed the data analysis. Many of the academic investigators in the study had consulting arrangements with Novartis or received research grants from the company.
Lead author Kenneth Lyles of Duke University said the analysis was independently confirmed.
Write to David Armstrong at david.armstrong@wsj.com
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