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Efficacy and tolerability of once-weekly administration of 17.5 mg risedronate in Japanese patients with involutional osteoporosis: a comparison with 2.5-mg once-daily dosage regimen

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Abstract

In this multicenter, randomized, double-blind controlled trial, the efficacy and safety of once-weekly dosing with 17.5 mg risedronate was compared with once-daily dosing with 2.5 mg risedronate in Japanese patients with involutional osteoporosis. A total of 496 patients were randomized to receive either once-weekly (n = 249) or once-daily (n = 247) treatment. All patients were supplemented with 200 mg/day calcium. Following 48 weeks of treatment, the mean (±SD) percent changes, from baseline, in the bone mineral density of the lumbar spine (L2-L4 BMD) in the once-weekly and once-daily treatment groups were 5.36 ± 4.27% and 5.87 ± 4.47%, respectively. The difference between the groups was −0.5% (95% confidence interval: −1.35% to 0.35%), demonstrating that the effect on BMD of once-weekly treatment was not inferior to that of once-daily treatment. The time-course reductions in biochemical markers of bone resorption (urinary N- and C-telopeptide of type I collagen) and bone formation (bone-specific alkaline phosphatase) were similar for the two dosing regimens. There were no differences in the incidence of new vertebral fractures or the worsening of existing fractures between the once-weekly (2.2%) and once-daily (2.7%) dosing regimens. No significant differences were observed between the two dosing regimens in the incidence or the type of adverse events. However, 10.1% of the patients in the once-daily group withdrew due to adverse events as compared to 5.2% in the once-weekly group. Moreover, drug-related adverse events, including upper gastrointestinal disorders and abnormal changes in laboratory parameters, tended to be less in the once-weekly dosing regimen than in the once-daily dosing regimen. In conclusion, once-weekly oral dosing with 17.5 mg risedronate was well tolerated in Japanese osteoporotic patients, and showed equivalent efficacy to once-daily oral dosing with 2.5 mg risedronate. This once-weekly regimen is expected to provide a more convenient therapeutic option as an alternative to daily dosing and to enhance patient compliance in long-term therapy for osteoporosis.

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Authors and Affiliations

  1. Department of Orthopedics, San-in Rosai Hospital, 1-8-1 Kaike-Shinden, Yonago, 683-0002, Japan

    Hideaki Kishimoto

  2. Department of Nuclear Medicine, Kawasaki Medical School, Okayama, Japan

    Masao Fukunaga

  3. Department of Orthopedics, Hamamatsu University School of Medicine, Shizuoka, Japan

    Kazuhiro Kushida

  4. Research Institute and Practice for Involutional Diseases, Nagano, Japan

    Masataka Shiraki

  5. Department of Clinical Laboratory Medicine, Saitama Medical School, Saitama, Japan

    Akira Itabashi

  6. Department of Internal Medicine, Faculty of Medicine, Kyushu University, Fukuoka, Japan

    Hajime Nawata

  7. Department of Orthopedics, University of Occupational and Environmental Health, Fukuoka, Japan

    Toshitaka Nakamura

  8. Department of Obstetrics and Gynecology, Tokyo Women's Medical University, Tokyo, Japan

    Hiroaki Ohta

  9. Department of Orthopedics, Osaka City University School of Medicine, Osaka, Japan

    Kunio Takaoka

  10. Biostatistics/Epidemiology and Preventive Health Sciences, School of Health Sciences and Nursing, University of Tokyo, Tokyo, Japan

    Yasuo Ohashi

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  1. Hideaki Kishimoto
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Correspondence to Hideaki Kishimoto.

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Kishimoto, H., Fukunaga, M., Kushida, K. et al. Efficacy and tolerability of once-weekly administration of 17.5 mg risedronate in Japanese patients with involutional osteoporosis: a comparison with 2.5-mg once-daily dosage regimen. J Bone Miner Metab 24, 405–413 (2006). https://doi.org/10.1007/s00774-006-0706-z

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  • DOI: https://doi.org/10.1007/s00774-006-0706-z

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