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| |  DG DISPATCH - WCO: Once-weekly Fosamax Dosing May Be On The Way By W. A. Thomasson, PhD Special to DG News
CHICAGO, IL -- June 19, 2000 -- If once-daily dosing is better than taking a medication several times a day, then once-weekly dosing should be even better -- especially when the dosing regimen is as inconvenient as that of Fosamax (alendronate sodium). This led Henry Bone, MD, of the Michigan Bone and Mineral Center in Detroit, MI, and his colleagues at other institutions to wonder whether Fosamax could in fact be taken just once a week. Data they presented yesterday (June 18) at the World Congress on Osteoporosis suggest that it can. As Dr. Bone reminded his listeners, the bone remodeling cycle runs for two to three weeks. Thus, once-weekly dosing might be expected to provide sustained control, since it would be almost certain to treat every osteoclast at least once. The resulting convenience might be especially important in a prevention setting, he further observed, in women who have not yet developed osteoporosis or sustained a fracture. The reported study was of the type known as an equivalence study, which is designed and statistical analyzed specifically to test whether two formulations are equivalent - rather than, as in the usual clinical trial, whether a formulation is different from placebo or an active comparator. Researchers enrolled 763 post-menopausal women who had normal bone mineral density (BMD) and were between the ages of 40 and 70 years. Half these women were randomly assigned -- on a double-blind basis -- to take 5 mg of Fosamax daily while the other half were assigned to take 35 mg weekly. Both regimens reduced bone resorption to the expected extent, bringing it into the pre-menopausal range. Likewise, both regimens increased bone mass by about 3 percent, which is what would be expected in a group of non-osteoporotic women. Statistical analysis confirmed that the groups were equivalent to within 1 percent regardless of the site at which bone mass was measured. There was also no difference in safety and tolerability, including effects on the gastrointestinal tract, between the two groups. "The conclusion is that this offers an alternative that many patients may find convenient," Dr. Bone said. Related Link: Fosamax (alendronate sodium).
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