Journal of Bone and Mineral Metabolism

, Volume 30, Issue 6, pp 715–721

The effect of risedronate (17.5 mg/week) treatment on quality of life in Japanese women with osteoporosis: a prospective observational study

Authors

  • Toshitaka Nakamura
    • Department of Orthopedic SurgeryUniversity of Occupational and Environmental Health
    • Department of Drug Promotion and Evolution CoordinationHeadquarters of Corporate Regulatory Compliance, Safety and Quality Assurance, Eisai Co., Ltd.
  • Makoto Itoh
    • Post-Marketing Medical Research DepartmentAjinomoto Pharmaceuticals Co., Ltd.
  • Hiromichi Yamaguchi
    • Department of Drug Promotion and Evolution CoordinationHeadquarters of Corporate Regulatory Compliance, Safety and Quality Assurance, Eisai Co., Ltd.
  • Norio Iinuma
    • Department of Drug Promotion and Evolution CoordinationHeadquarters of Corporate Regulatory Compliance, Safety and Quality Assurance, Eisai Co., Ltd.
  • Yutaka Hayakawa
    • Department of Drug Promotion and Evolution CoordinationHeadquarters of Corporate Regulatory Compliance, Safety and Quality Assurance, Eisai Co., Ltd.
  • Hitoshi Suzuki
    • Department of Drug Promotion and Evolution CoordinationHeadquarters of Corporate Regulatory Compliance, Safety and Quality Assurance, Eisai Co., Ltd.
  • Toshiaki Kamisaki
    • Post-Marketing Medical Research DepartmentAjinomoto Pharmaceuticals Co., Ltd.
  • Satoshi Iwayama
    • Post-Marketing Medical Research DepartmentAjinomoto Pharmaceuticals Co., Ltd.
  • Masahiko Nishikawa
    • Post-Marketing Medical Research DepartmentAjinomoto Pharmaceuticals Co., Ltd.
Original Article

DOI: 10.1007/s00774-012-0372-2

Cite this article as:
Nakamura, T., Osawa, M., Itoh, M. et al. J Bone Miner Metab (2012) 30: 715. doi:10.1007/s00774-012-0372-2

Abstract

A prospective observational study to test the effects of risedronate 17.5 mg/week treatment on quality of life (QOL) of 1,363 Japanese female patients with osteoporosis showed QOL improvement after 12 weeks of administration. Comorbid factors such as ischemic heart disease, hip osteoarthritis, and higher values of FRAX blunted the effects of QOL of the treatment. Few studies have investigated the effect of osteoporosis treatment on QOL in relationship to comorbid factors other than osteoporosis and fracture. Efficacy was determined by changes over time in EQ-5D at baseline, at 12 and 24 weeks, and at the final assessment. Factors affecting changes in EQ-5D were evaluated with a multivariate analysis. Safety was determined by assessing the incident rate of adverse events. The improvement of EQ-5D compared to baseline was observed as significant after 12 weeks of treatment (p < 0.001). The greatest improvement was observed in the dimension of “pain/discomfort” by the multivariate analysis (p < 0.001). Factors affecting QOL improvement were FRAX value without BMD, age, glucocorticoid use, ischemic heart disease, hip osteoarthritis, and pain. The incidence rate of drug-related adverse events was 4.72 % (95 % confidence interval 3.63–6.02 %). Risedronate at 17.5 mg/week improved the QOL in patients with osteoporosis among Japanese women, and comorbidity factors decreased the effects.

Keywords

EQ-5D FRAX Comorbid factors Ischemic heart disease Osteoarthritis

Copyright information

© The Japanese Society for Bone and Mineral Research and Springer 2012