title: Fracture incidence and changes in quality of life in women with an inadequate clinical outcome from osteoporosis therapy: the Observational Study of Severe Osteoporosis (OSSO).
abstract: In this observational study of women with an inadequate clinical outcome to osteoporosis therapy, those with a fracture at baseline were more likely to sustain an incident fracture and have a worse health-related quality of life than those without prior fracture.
  
  
  BACKGROUND
  The Observational Study of Severe Osteoporosis (OSSO) was designed to assess the fracture incidence and health-related quality of life (HRQoL) in women with an inadequate clinical outcome to osteoporosis therapy.
  
  
  METHODS
  Post-menopausal women (N=1,885) with established osteoporosis and an inadequate clinical response to osteoporosis drug therapy defined as: a) a fragility fracture despite therapy for one year (index fracture, N=988), or b) discontinued drug therapy due to adverse effects and/or non-compliance (N=897), were assessed during one year for HRQoL using the EQ-5D and the QUALEFFO questionnaires.
  
  
  RESULTS
  One hundred and sixty-six (8.8%) women had a total of 209 incident fractures (1,139 fractures/10,000 women-years). Women with an index fracture were more likely to sustain an incident fracture than those without prior fractures (hazard ratio 1.91; 95% CI: 1.37-2.66; p<0.001). Co-morbidities or antidepressant use at baseline also increased the risk of incident fracture. Median total EQ-5D Health State Values and QUALEFFO scores were worse in women with an incident fracture regardless of index fracture status. The worst scores were reported in the EQ-5D sub-domains of self-care, usual activities and pain/discomfort.
  
  
  CONCLUSIONS
  Women with an inadequate response to osteoporosis therapy had a high rate of incident fracture which had an adverse impact on HRQoL.
authors.affiliation: MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK. cc@mrc.soton.ac.uk
authors.forename: C
authors.initials: C
authors.lastname: Cooper
authors.forename: F
authors.initials: F
authors.lastname: Jakob
authors.forename: C
authors.initials: C
authors.lastname: Chinn
authors.forename: E
authors.initials: E
authors.lastname: Martin-Mola
authors.forename: P
authors.initials: P
authors.lastname: Fardellone
authors.forename: S
authors.initials: S
authors.lastname: Adami
authors.forename: N C
authors.initials: NC
authors.lastname: Thalassinos
authors.forename: J
authors.initials: J
authors.lastname: Melo-Gomes
authors.forename: D
authors.initials: D
authors.lastname: Torgerson
authors.forename: A
authors.initials: A
authors.lastname: Gibson
authors.forename: F
authors.initials: F
authors.lastname: Marin
mesh_terms: D000328:Adult; D000368:Aged; D015519:Bone Density / Q000502:physiology; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D050723:Fractures, Bone / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000503:physiopathology / Q000628:therapy*; D010349:Patient Compliance / Q000706:statistics & numerical data; D011788:Quality of Life / Q000523:psychology*; D011795:Surveys and Questionnaires; D017211:Treatment Failure; D016387:Women's Health
chemical_list: D050071:Bone Density Conservation Agents