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From the Clinical Research Centers |
Medical College of Virginia (R.W.D.), Richmond, Virginia 23219; Medical University of South Carolina (N.H.B.), Charleston, South Carolina 29401; Clinical Research Center of South Florida (M.P.E.), Stuart, Florida 34996; Brigham and Women’s Hospital (B.W.W.), Boston, Massachusetts 02115; University of Chicago (M.J.F.), Chicago, Illinois 60637; and Merck and Co., Inc. (B.M., L.W., M.E.S., G.J.G., M.E.M.), West Point, Pennsylvania 19486
Address correspondence and requests for reprints to: Mary E. Melton, M.D., Merck and Co., Inc., WS2C-55, One Merck Drive, Whitehouse Station, New Jersey 08889.
This study compared the effects of oral alendronate and intranasal calcitonin for treatment of osteoporosis in postmenopausal women. Women at least 5 yr postmenopause (n = 299) were randomized to either 10 mg alendronate, matching alendronate placebo, or open-label intranasal calcitonin 200 IU daily for 12 months. Hip and spine bone mineral density (BMD) and markers of bone turnover were measured, and safety and tolerability were assessed. Alendronate produced greater increases in BMD than calcitonin at 12 months at the lumbar spine (5.16% vs. 1.18%; P < 0.001), trochanter (4.73% vs. 0.47%; P < 0.001), and femoral neck (2.78% vs. 0.58%; P < 0.001). Changes in BMD with calcitonin were greater than with placebo at the femoral neck, but were not different from placebo at either the trochanter or lumbar spine. Greater decreases in bone turnover were seen with alendronate than with calcitonin (serum bone-specific alkaline phosphatase, 43% vs. 9%, P < 0.001; urinary N-telopeptide, 62% vs. 11%, P < 0.001). Similar percentages of patients in each group reported an adverse experience during the study. We conclude that, in postmenopausal women with osteoporosis, 12 months of therapy with alendronate produced significantly greater increases in BMD of the hip and spine and greater decreases in bone turnover than intranasal calcitonin.
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