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Title: Greater Increases in Bone Mineral Density with Raloxifene Plus Alendronate Compared to Either Drug Alone: Presented at ACP

"Greater Increases in Bone Mineral Density with Raloxifene Plus Alendronate Compared to Either Drug Alone: Presented at ACP"

By Daniel Keller SAN DIEGO, CA -- April 7, 2003 -- Administration of raloxifene and alendronate together results in greater increases in bone mineral density (BMD) at 1 year compared to either drug alone, according to a randomized, double-blind study. Glenn Braunstein, MD, Chairman, Department of Medicine, Cedars-Sinai Medical Center, Professor of Medicine, University of California Los Angeles School of Medicine, reviewed this study here April 4th at the Annual Session of the American College of Physicians. The drugs have different mechanisms of action. Raloxifene is a selective estrogen receptor modulator and acts similarly to estrogen on bone. Alendronate is a bisphosphonate. Both inhibit osteoclastic bone resorption. The study tested a combination of the two drugs for 1 year in 133 postmenopausal women with osteoporosis. The women were randomized in a double-blind fashion to raloxifene, alendronate, a combination of the two, or placebo. Doses were at 60 mg/day for raloxifene and 10 mg/day for alendronate. Femoral neck T-scores were less than -2 standard deviations from the mean. Women who received either drug alone had increases in BMD in the lumbar spine. "And patients who received both together had a further increase in bone mineral density in the lumbar spine, and the same effect was found in the femoral neck," he said. "So the combination of the two was better than either alone." At 1 year, femoral neck BMD increased by 3.7% with the two drugs combined, compared to increases of 2.7% for alendronate alone (P=0.02) or 1.7% for raloxifene alone (P=0.001). Lumbar spine BMD increased by 5.3%, 4.3%, and 2.1% from baseline for the combination, alendronate alone, and raloxifene alone, respectively, but these differences were not statistically significant. For all three groups, markers of bone resorption decreased within 30 days. By 3 months, markers of bone formation decreased, secondary to inhibition of bone resorption mediated by the treatments. The study authors concluded that raloxifene and alendronate together decreased bone resorption more than either drug alone, Dr. Braunstein said. These findings are similar to ones from other studies, he added. "So the take-home message is one can combine inhibitors of bone resorption and get an additive effect -- obviously different classes of inhibitors of bone resorption," he said. A remaining question is whether the combination of drugs will incidence of reduce fractures more than either drug alone, he added.

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