title: Health state utility values and patient-reported outcomes before and after vertebral and non-vertebral fractures in an osteoporosis clinical trial.
abstract: We assessed the health state utility value (HSUV) reductions associated with vertebral fractures using data collected in the Japanese Osteoporosis Intervention Trial-03 (JOINT-03). Our analysis revealed that assessment of HSUVs after morphometric vertebral fracture is important to capture the burden of vertebral fractures.
  
  
  
  Evaluation of the HSUV after fracture is important to calculate the quality-adjusted life years (QALYs) of osteoporosis patients, which is essential information in the context of health economic evaluation.
  
  
  
  JOINT-03 study patients were aged ≥65 years and treated with risedronate and vitamin K2or risedronate alone. Radiographic information and patient-reported outcomes measured by EQ-5D and a visual analogue scale (VAS) were assessed at registration and followed up after 6, 12, and 24 months. According to differences among the dates of these assessments and the radiographic information, we classified the follow-up HSUVs calculated based on EQ-5D results into before or after fracture categories regardless of clinical symptoms.
  
  
  
  Among 2922 follow-up HSUVs, 201 HSUVs were categorized as HSUVs that were observed after incident vertebral fractures on X-ray films. The median time from the detection of an incident vertebral fracture until the EQ-5D assessment was 53 days (25th percentile, 0 day; 75th percentile, 357 days). The impact of incident vertebral fractures on HSUVs was quantified as -0.03. Among the five health profile domains on the EQ-5D, an incident vertebral fracture had significant effects on anxiety/depression, self-care, and usual activities.
  
  
  
  The results suggest that incident morphometric vertebral fracture was associated with impairment of the HSUV for patients with osteoporosis not only immediately but also several months after the fracture.
authors.affiliation: Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, 606-8501, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Imai
authors.affiliation: Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, 606-8501, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Tanaka
authors.affiliation: Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, 606-8501, Japan. kawakami.koji.4e@kyoto-u.ac.jp.
authors.forename: K
authors.initials: K
authors.lastname: Kawakami
authors.affiliation: Public Health Research Foundation, Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Miyazaki
authors.affiliation: School of Health Science, Tottori University Faculty of Medicine, Tottori, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Hagino
authors.affiliation: Department of Internal Medicine, Research Institute and Practice for Involutional Diseases, Nagano, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Shiraki
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D050071:Bone Density Conservation Agents / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007564:Japan / Q000453:epidemiology; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology / Q000534:rehabilitation*; D058866:Osteoporotic Fractures / Q000150:complications / Q000453:epidemiology / Q000534:rehabilitation*; D010146:Pain / Q000453:epidemiology / Q000209:etiology; D010147:Pain Measurement / Q000379:methods; D000071066:Patient Reported Outcome Measures; D019057:Quality-Adjusted Life Years; D000068296:Risedronic Acid / Q000627:therapeutic use; D016103:Spinal Fractures / Q000150:complications / Q000453:epidemiology / Q000534:rehabilitation*; D024482:Vitamin K 2 / Q000627:therapeutic use
chemical_list: D050071:Bone Density Conservation Agents; D024482:Vitamin K 2; D000068296:Risedronic Acid
keywords: Health economics; Health state utility value; Morphometric vertebral fracture; Osteoporosis; Radiographic assessment