title: Quality of life in raloxifene-treated Japanese women with postmenopausal osteoporosis: a prospective, postmarketing observational study.
abstract: OBJECTIVE
  To assess changes in quality of life (QOL) and pain in raloxifene-treated Japanese women with postmenopausal osteoporosis.
  
  
  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 (60 mg/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 ≥20 mm 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Orthopedic Surgery, Sasayama Hospital, Hyogo College of Medicine, Sasayama, Japan.
authors.forename: Kousei
authors.initials: K
authors.lastname: Yoh
authors.forename: Etsuro
authors.initials: E
authors.lastname: Hamaya
authors.forename: Hisashi
authors.initials: H
authors.lastname: Urushihara
authors.forename: Noriko
authors.initials: N
authors.lastname: Iikuni
authors.forename: Takanori
authors.initials: T
authors.lastname: Yamamoto
authors.forename: Masanori
authors.initials: M
authors.lastname: Taketsuna
authors.forename: Akimitsu
authors.initials: A
authors.lastname: Miyauchi
authors.forename: Hideaki
authors.initials: H
authors.lastname: Sowa
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Tanaka
mesh_terms: D000368:Aged; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007564:Japan; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000503:physiopathology; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011788:Quality of Life; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D020849:Raloxifene Hydrochloride