Objective:To assess changes in quality of life (QOL) and pain in raloxifene-treated Japanese women with postmenopausal osteoporosis. Research design and methods:This prospective, postmarketing observational study was conducted at 60 Japanese hospitals from September 2007 to February 2009 and included Japanese women with postmenopausal osteoporosis who were new to standard treatment with raloxifene (60mg/day). Primary outcome measures (QOL and pain) were assessed using the Short Form-8 (SF-8), European Quality of Life Instrument (EQ-5D), osteoporosis-specific Japanese Osteoporosis Quality of Life Questionnaire (JOQOL), a visual analogue scale (VAS-pain), and a pain frequency survey. Assessments were performed at baseline and 8 (except JOQOL) and 24 weeks after first administration of raloxifene. Adverse drug reactions were recorded. Japan Pharmaceutical Information Center registration number: JapicCTI-070465. Results:A total of 506 participants, mean (±standard deviation [SD]) age=70.7±8.7 years, completed 1 follow-up assessment and were included in the analyses. All QOL scores increased from baseline during follow-up. All SF-8 domain scores increased significantly from baseline after 8 and 24 weeks (P<0.001). Mean (±SD) EQ-5D scores increased significantly from baseline (0.70±0.17) by 0.05±0.15 after 8 weeks and 0.07±0.17 after 24 weeks (P<0.001). The mean (±SD) total JOQOL score increased significantly from baseline (66.8±16.5) by 3.8±11.3 after 24 weeks (P<0.001). The percentage of participants with a 20mm reduction in VAS-pain was 32.6% (120/368) and 39.5% (115/291) after 8 and 24 weeks, respectively. The frequency of pain reported by participants decreased after 8 and 24 weeks. Forty adverse drug reactions were reported by 34 participants. Limitations:Limitations include the lack of a control group, the possibility of the changes being due to the natural disease course, and potential selection bias. Conclusions:Our findings suggest that standard treatment with raloxifene improves QOL and relieves pain in Japanese women with postmenopausal osteoporosis in a real-world clinical setting.
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