title: Early effects of raloxifene on clinical vertebral fractures at 12 months in postmenopausal women with osteoporosis.
abstract: BACKGROUND
  Raloxifene hydrochloride therapy reduces the risk for vertebral fractures at 3 years, but the effects on clinical vertebral fractures in the first year are not known.
  
  
  METHODS
  The Multiple Outcomes of Raloxifene Evaluation (MORE) Trial enrolled 7705 women with osteoporosis, defined by prevalent vertebral fractures and/or a bone mineral density (BMD) T score at or below -2.5, who were treated with placebo or raloxifene at a dosage of 60 or 120 mg/d for 3 years. New clinical vertebral fractures were defined as incident vertebral fractures associated with signs and symptoms suggestive of vertebral fractures, such as back pain, and were diagnosed by means of postbaseline adjudicated spinal radiographs. Scheduled spinal radiographs were obtained at baseline and at 2 and 3 years. In addition, unscheduled spinal radiographs were obtained in women who reported signs or symptoms suggestive of vertebral fracture, and these radiographs subsequently underwent adjudication. If an adjudicated fracture was identified, this was also considered a clinical fracture.
  
  
  RESULTS
  At 1 year, raloxifene, 60 mg/d, decreased the risk for new clinical vertebral fractures by 68% (95% confidence interval [CI], 20%-87%) compared with placebo in the overall study population, and by 66% (95% CI, 23%-89%) in women with prevalent vertebral fractures, who are at greater risk for subsequent fracture. The risk for clinical vertebral fractures in the raloxifene, 60 mg/d, group was decreased by 46% (95% CI, 14%-66%) at 2 years and by 41% (95% CI, 17%-59%) at 3 years. The cumulative incidence of new clinical vertebral fractures was lower in the group receiving raloxifene, 60 mg/d, compared with placebo (P<.001). We found no significant differences in the risk reductions for clinical vertebral fractures between the raloxifene groups at 1, 2, or 3 years.
  
  
  CONCLUSIONS
  The early risk reduction for new clinical vertebral fractures with 1 year of raloxifene treatment was similar to that reported with other antiresorptive agents.
authors.affiliation: Section of Rheumatology, Southern Arizona Veterans Affairs Health Care System, 3601 S Sixth Ave, Tucson, AZ 85723, USA. mikemaricic@msn.com
authors.forename: Michael
authors.initials: M
authors.lastname: Maricic
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Adachi
authors.forename: Somnath
authors.initials: S
authors.lastname: Sarkar
authors.forename: Wentao
authors.initials: W
authors.lastname: Wu
authors.forename: Mayme
authors.initials: M
authors.lastname: Wong
authors.forename: Kristine D
authors.initials: KD
authors.lastname: Harper
mesh_terms: D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D012008:Recurrence; D012306:Risk; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use*; D016103:Spinal Fractures / Q000453:epidemiology / Q000517:prevention & control*; D013997:Time Factors
chemical_list: D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride