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The efficacy and tolerability of once-weekly alendronate 70 mg on bone mineral density and bone turnover markers in postmenopausal Chinese women with osteoporosis

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Abstract

Osteoporosis has become an important health problem in postmenopausal Chinese women. Bisphosphonates currently are the preferred therapy for treating osteoporosis. However, the use of daily regimen of alendronate in women at risk for osteoporosis has been relatively low in China because of its dosing inconvenience. To determine the efficacy and tolerability of once-weekly alendronate 70 mg in Chinese, a multicenter, randomized, double blind, placebo controlled study was performed in China. Five hundred and sixty postmenopausal women (≤85 years old) with osteoporosis were randomly assigned to receive either alendronate 70 mg or placebo once-weekly for 12 months. All women received calcium 500 mg daily and vitamin D 200 IU daily. A significant increase in lumbar spine BMD was already evident at 6 months of alendronate treatment (P < 0.001). The alendronate group showed significant increase (P < 0.001) in BMD at 12 months at both the spine and hip when compared with the placebo group (lumbar spine 4.87% vs. 0.4%, femoral neck 2.47% vs. 0.31%, trochanter 3.24% vs. 0.78%, total hip 2.56% vs. 0.28%, respectively). The percentage of women with ≥0% and ≥3% BMD increase in lumbar spine was significantly greater in women with alendronate than placebo (P < 0.001). Significant reduction in urine N-telopeptide (NTx) and serum bone-specific alkaline phosphatase were evident at 6 and 12 months, respectively, with alendronate treatment. No significant differences in the incidence of adverse experiences and upper gastrointestinal adverse experiences were seen. We conclude that once-weekly alendronate 70 mg is an effective and well-tolerated agent for the treatment of postmenopausal osteoporosis in Chinese women.

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Acknowledgments

The authors gratefully acknowledge the dedicated efforts of the study investigators and staff at the clinical study centers, and recognize the participants for their commitment to this trial. This study was funded by Beijing PHR Grant 107508(04) and CSPC Group.

Conflict of interest statement

There was no conflict of interest in this study.

Author information

Authors and Affiliations

  1. Department of Epidemiology and Biostatistics, School of Public Health and Family Medicine, Capital Medical University, 100069, Beijing, China

    Yuxiang Yan & Wei Wang

  2. Department of Gerontology, Shanghai Huadong Hospital, Shanghai, China

    Hanmin Zhu

  3. Department of Endocrinology, Peking Union Medical College Hospital, Beijing, China

    Mei Li

  4. Department of Obstetrics and Gynecology, China PLA General Hospital, Beijing, China

    Jianli Liu

  5. Department of Endocrinology, Shanghai Ruijin Hospital, Shanghai, China

    Bangyao Luo

  6. Gerontological Institute of Zhejiang Hospital, Hangzhou, China

    Haibao Xie

  7. Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China

    Guangjian Zhang

  8. Department of Orthopaedics, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China

    Fuobao Li

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  1. Yuxiang Yan
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  2. Wei Wang
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  3. Hanmin Zhu
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  4. Mei Li
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Correspondence to Yuxiang Yan.

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Yan, Y., Wang, W., Zhu, H. et al. The efficacy and tolerability of once-weekly alendronate 70 mg on bone mineral density and bone turnover markers in postmenopausal Chinese women with osteoporosis. J Bone Miner Metab 27, 471–478 (2009). https://doi.org/10.1007/s00774-009-0057-7

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  • DOI: https://doi.org/10.1007/s00774-009-0057-7

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