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      Five-year alendronate treatment outcome in older postmenopausal Japanese women with osteoporosis or osteopenia and clinical risk factors for fractures

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          A retrospective study was conducted to evaluate the outcome of treatment with alendronate (ALN) for 5 years in postmenopausal Japanese women with an increased risk of fractures. Forty postmenopausal Japanese women with osteoporosis or osteopenia and clinical risk factors for fractures (mean age: 75.4 years) were analyzed; 33 patients were treated with alendronate and 7 were treated with alfacalcidol (ALF, controls) in an outpatient clinic run by general practitioners. The metacarpal bone mineral density (BMD) measured using a computed X-ray densitometer, urinary levels of cross-linked N-terminal telopeptides of type I collagen (NTX), and serum levels of alkaline phosphatase (ALP) were monitored during the 5-year treatment period. The urinary NTX and serum ALP levels decreased significantly in the ALN group, compared with the ALF group. The metacarpal BMD was sustained in the ALN group but decreased significantly in the ALF group; the difference between these two groups was also significant. The present study evaluated the outcome of treatment with ALN for 5 years in postmenopausal Japanese women with osteoporosis or osteopenia and clinical risk factors for fractures. ALN successfully suppressed bone turnover and sustained the metacarpal BMD over the 5-year period of treatment in postmenopausal Japanese women with an increased risk of fractures.

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          Ten years' experience with alendronate for osteoporosis in postmenopausal women.

          Antiresorptive agents are widely used to treat osteoporosis. We report the results of a multinational randomized, double-blind study, in which postmenopausal women with osteoporosis were treated with alendronate for up to 10 years. The initial three-year phase of the study compared three daily doses of alendronate with placebo. Women in the original placebo group received alendronate in years 4 and 5 and then were discharged. Women in the original active-treatment groups continued to receive alendronate during the initial extension (years 4 and 5). In two further extensions (years 6 and 7, and 8 through 10), women who had received 5 mg or 10 mg of alendronate daily continued on the same treatment. Women in the discontinuation group received 20 mg of alendronate daily for two years and 5 mg daily in years 3, 4, and 5, followed by five years of placebo. Randomized group assignments and blinding were maintained throughout the 10 years. We report results for the 247 women who participated in all four phases of the study. Treatment with 10 mg of alendronate daily for 10 years produced mean increases in bone mineral density of 13.7 percent at the lumbar spine (95 percent confidence interval, 12.0 to 15.5 percent), 10.3 percent at the trochanter (95 percent confidence interval, 8.1 to 12.4 percent), 5.4 percent at the femoral neck (95 percent confidence interval, 3.5 to 7.4 percent), and 6.7 percent at the total proximal femur (95 percent confidence interval, 4.4 to 9.1 percent) as compared with base-line values; smaller gains occurred in the group given 5 mg daily. The discontinuation of alendronate resulted in a gradual loss of effect, as measured by bone density and biochemical markers of bone remodeling. Safety data, including fractures and stature, did not suggest that prolonged treatment resulted in any loss of benefit. The therapeutic effects of alendronate were sustained, and the drug was well tolerated over a 10-year period. The discontinuation of alendronate resulted in the gradual loss of its effects. Copyright 2004 Massachusetts Medical Society
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            Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial.

            Alendronate sodium reduces fracture risk in postmenopausal women who have vertebral fractures, but its effects on fracture risk have not been studied for women without vertebral fractures. To test the hypothesis that 4 years of alendronate would decrease the risk of clinical and vertebral fractures in women who have low bone mineral density (BMD) but no vertebral fractures. Randomized, blinded, placebo-controlled trial. Eleven community-based clinical research centers. Women aged 54 to 81 years with a femoral neck BMD of 0.68 g/cm2 or less (Hologic Inc, Waltham, Mass) but no vertebral fracture; 4432 were randomized to alendronate or placebo and 4272 (96%) completed outcome measurements at the final visit (an average of 4.2 years later). All participants reporting calcium intakes of 1000 mg/d or less received a supplement containing 500 mg of calcium and 250 IU of cholecalciferol. Subjects were randomly assigned to either placebo or 5 mg/d of alendronate sodium for 2 years followed by 10 mg/d for the remainder of the trial. Clinical fractures confirmed by x-ray reports, new vertebral deformities detected by morphometric measurements on radiographs, and BMD measured by dual x-ray absorptiometry. Alendronate increased BMD at all sites studied (P 2.5 SDs below the normal young adult mean; RH, 0.64; 95% CI, 0.50-0.82; treatment-control difference, 6.5%; number needed to treat [NNT], 15), but there was no significant reduction among those with higher BMD (RH, 1.08; 95% CI, 0.87-1.35). Alendronate decreased the risk of radiographic vertebral fractures by 44% overall (relative risk, 0.56; 95% CI, 0.39-0.80; treatment-control difference, 1.7%; NNT, 60). Alendronate did not increase the risk of gastrointestinal or other adverse effects. In women with low BMD but without vertebral fractures, 4 years of alendronate safely increased BMD and decreased the risk of first vertebral deformity. Alendronate significantly reduced the risk of clinical fractures among women with osteoporosis but not among women with higher BMD.
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              Diagnostic criteria for primary osteoporosis: year 2000 revision.

               Hiroto Tanaka,  Y. Oh,   (2000)

                Author and article information

                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                12 October 2009
                : 5
                : 773-779
                [1 ] Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, Japan;
                [2 ] Department of Internal Medicine, Yahata Clinic, Tokyo, Japan;
                [3 ] Department of Neurology, Mitate Hospital, Fukuoka, Japan
                Author notes
                Correspondence: Jun Iwamoto, Institute for Integrated Sports Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan, Tel +81 3 3353 1211, Fax +81 3 3352 9467, Email jiwamoto@ 123456sonata.plala.or.jp
                © 2009 Iwamoto et al, publisher and licensee Dove Medical Press Ltd.

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

                Original Research


                postmenopausal women, alendronate, osteopenia, risk factors for fractures, osteoporosis


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