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

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.