An osteoporosis drug given intravenously once a year significantly reduces the occurrence of new fractures and the incidence of death in patients who have had a hip fracture.
A study of 2,127 patients who received the drug zoledronic acid (trade name Reclast) within 90 days of surgery for a hip fracture had a 28 percent reduction in death and were 35 percent less likely to suffer another fracture. Patients were followed for an average of 1.9 years. About 25 percent of the patients studied were men. The leader of the multi-centre clinical trial believes that the use of zoledronic acid can play an important role in reducing the risk of further fractures for elderly patients who have suffered a hip fracture, a common occurrence that is linked to reduced independence and higher rates of death. “These data show that we can go beyond cutting the risks of future fractures to reducing the death rate after these disabling fractures,” said Kenneth W. Lyles, M.D., geriatrician and endocrinologist who works at Duke University Medical Center, the Durham VA Medical Center and The Carolina’s Center for Medical Excellence, Cary, N.C. It is estimated that 345,000 Americans are hospitalized each year with a hip fracture. Suffering from a hip fracture significantly increases a patient’s risk of walking impairment and the need to spend time in a long term care facility, Lyles said. Approximately 15 to 25 percent of hip fracture patients will die within a year of their fracture, according to Lyles. The results of the international clinical trial were published online Sept. 17 by the New England Journal of Medicine to coincide with Lyles’ presentation of the data at the annual meeting of American Society of Bone and Mineral Research in Honolulu. Zoledronic acid is manufactured by Novartis Pharma, which funded the study. Lyles has received grant support and consulting fees from Novartis, and is an inventor on two use patent application filings for the drug. Zoledronic acid, which was approved in August by the Food and Drug Administration for the treatment of osteoporosis in postmenopausal women, works by preventing the loss of existing bone. While earlier studies have demonstrated that the drug can reduce fractures and improve bone density in patients with osteoporosis, the results of the new trial are the first to demonstrate that the drug can save lives. “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. Specifically, the researchers found that 8.6 percent of the study patients taking zoledronic acid suffered a new fracture, compared to 13.9 percent of those not taking the drug. During the course of the trial, 9.6 percent of zoledronic acid patients died, compared to 13.3 percent of those not taking the drug. While it is known that patients who suffer hip fractures, especially the very old, are at an increased risk of dying, it is likely that the decrease in fractures seen in the patients taking zoledronic acid is only partly responsible for their improved survival, Lyles said. He added that many factors are involved and further study is needed to identify them. Zoledronic acid is known as a bisphosphonate, the same class as oral osteoporosis drugs such as Fosamax, Actonel, and Boniva (all trade names). None of the patients in the current trial were taking any of these medications. Lyles said patients taking the drug need to take supplemental Vitamin D and calcium, and about 15 percent of patients will have flu-like symptoms shortly after the infusion. These symptoms can be addressed by taking acetaminophen or a non-steroidal anti-inflammatory drug prior to the infusion and for three days afterward. While there have been reports of atrial fibrillation in patients receiving zoledronic acid in a previous trial, Lyles said there was no increased risk in the patients who received zoledronic acid in this study. There were no cases of osteonecrosis of the jaw, a painful jaw condition, which has been previously reported with this class of drugs. Patients were recruited from hospitals throughout the world, including the United States, South and Central America, Europe and Canada A trial led by Lyles reported in 2005 that a single intravenous dose of zoledronic acid was effective in treating patients with Paget’s disease, a debilitating bone disease. (Source: New England Journal of Medicine : Chris DiFrancesco : Duke University : October 2007)