Once-a-Year Drug Helps Counter Steroid-Linked Bone Loss
FRIDAY April 10, 2009 -- Patients with rheumatoid arthritis or asthma often need to take a bone-strengthening drug to counter the debilitating effects of their steroid medications.
Now, a new study finds that a once-yearly injection of a bisphosphonate bone-building drug, Reclast, may work better than a once-daily bisphosphonate pill for these patients.
Specifically, Reclast (zoledronic acid) was found to hold off and/or reverse bone loss among patients taking a glucocorticoid medication (including prednisolone or prednisone) for one of several inflammatory and immune-related diseases, including asthma, lupus and rheumatoid arthritis. And it did so more effectively than a daily dose of an oral bisphosphonate, Actonel (risedronate). Actonel is also available as a once-weekly and once-monthly pill.
The research team also found that both drugs appeared successful in lowering the risk of bone fracture that can result from glucocorticoid use.
The new study was funded by Novartis, which makes Reclast to help fight osteoporosis-linked bone loss in postmenopausal women. Novartis also makes another form of zoledronic acid, Zometa, for use by cancer patients.
"The important point is that people who take glucocorticoid steroids for asthma or arthritis are all in danger of getting osteoporosis or fractures as a consequence," said study lead author Dr. David M. Reid, professor of rheumatology and head of the division of applied medicine at University of Aberdeen, Scotland. "But now, we have found that there is a simple way of preventing that almost absolutely by applying a single infusion once a year of this safe and effective drug."
Reid and his colleagues reported their findings in the April 11 issue of The Lancet.
While bisphosphonate drugs can strengthen bone, they are not without their problems. For example, recent studies have suggested links between long-term use of oral bisphosphonates such as Fosamax (alendronate) to a heightened risk for irregular heartbeat and a particular type of fracture.
For the current investigation, Reid and his colleagues spent a year comparing the effects of Reclast with those of Actonel, taken daily, among 833 patients already being treated with glucocorticoid drugs. The study took place at 54 health facilities spread across 12 European countries, Australia, Hong Kong, Israel and the United States.
The team found that among patients who had been taking glucocorticoids for more than three months prior to the study launch, one 5-milligram shot of Reclast increased bone mineral density (BMD) in the lower part of their back by an average of just over 4 percent. By contrast, daily doses of 5 milligrams of Actonel, taken orally, achieved a 2.7 percent rise in BMD in such patients.
Reclast was similarly effective among participants who had been taking glucocorticoids for less than three months, raising their BMD by 2.7 percent compared with the daily medications' 2.0 percent boost.
"And there were virtually no fractures among the zoledronic [Reclast] patients over the course of the year," noted Reid. "The only thing with the single infusion that makes it a bit troublesome is that some patients might get a slightly flu-ish feeling for up to 48 hours after the infusion. And we would have to be wary of making sure that patients maintain a good level of vitamin D in their system when using this drug. But otherwise, there are no serious consequences to the method."
The new study follows a report, recently released by Austrian researchers, that indicated that zoledronic acid might also help lower the risk for breast cancer, as well as the risk for cancer spreading to bones. Those results were presented at the American Society of Clinical Oncology's annual meeting, held in Chicago last May.
Reid cautioned, however, that Reclast still requires approval by the U.S. Food and Drug Administration before being made available to American patients for use in patients taking glucocorticoid drugs. "However, I'm optimistic that this approval will eventually come through," he said.
Dr. Mone Zaidi, a professor of medicine and physiology and director of the Mount Sinai Bone Program at the Mount Sinai School of Medicine, New York City, described the current finding as a "major breakthrough."
"I think the successful once-a-year use of this long-acting bisphosphonate is perhaps once of the most dramatic events that has occurred in the osteoporosis arena in the last few years," he said. "For a long time, many of us have thought this would prove to be the case, based on our own clinical use, but now it has been demonstrated very clearly, and will be very relevant for all those patients at risk for bone loss and fracture."
For more about bone loss, visit the U.S. National Institutes of Health.
Posted: April 2009