title: Back pain during different sequential treatment regimens of teriparatide: results from EUROFORS.
abstract: OBJECTIVE
  To investigate changes in back pain in postmenopausal women with severe osteoporosis who received teriparatide for 24 months or switched at 12 months to raloxifene or no active treatment.
  
  
  METHODS
  This prospective, controlled, randomised, open-label, 2-year study enrolled 868 postmenopausal women with osteoporosis and a recent fragility fracture. After 12 months of teriparatide (20 microg/day), 507 patients were randomised to further teriparatide (n = 305), raloxifene 60 mg/day (n = 100), or no active treatment (n = 102) for another 12 months (substudy 1); in substudy 2, 199 patients continued teriparatide. All received calcium and vitamin D supplementation. Back pain was self-assessed by patients using a visual analogue scale (0-100 mm). Changes in back pain were analysed using a mixed model for repeated measures.
  
  
  RESULTS
  During year 1, back pain decreased from a mean (SD) of 48.9 mm (24.0) at baseline by 11.5 mm (p < 0.001) in the total study population. In substudy 1, mean change in back pain from month 12 (randomisation) to 24 months was -2.2, -4.4 and +0.7 mm in the teriparatide (p = 0.076), raloxifene (p = 0.041), and no active treatment groups (p = 0.751). There were no between-group differences from randomization to 18 or 24 months. In a sensitivity analysis excluding patients with low baseline back pain (VAS < 30 mm), mean change from randomisation to endpoint was significant for teriparatide (-3.9 mm, p = 0.006) and raloxifene (-6.3 mm, p = 0.018) groups. Subgroup analyses of 503 patients who received teriparatide for up to 2 years showed that patients with a recent vertebral fracture had a greater decrease in back pain than those without (p < 0.05). Those with and without mild back pain (>or=30 mm), and those with and without severe back pain (>or=60 mm) at baseline all had a statistically significant reduction in back pain after 24 months (p < 0.05).
  
  
  CONCLUSIONS
  Teriparatide treatment is associated with significant reductions in back pain regardless of the presence of recent vertebral fracture. These results need to be considered with caution due to the open-label design of the study.
authors.affiliation: University of Athens, Greece.
authors.forename: George
authors.initials: G
authors.lastname: Lyritis
authors.forename: Fernando
authors.initials: F
authors.lastname: Marin
authors.forename: Clare
authors.initials: C
authors.lastname: Barker
authors.forename: Michael
authors.initials: M
authors.lastname: Pfeifer
authors.forename: Jordi
authors.initials: J
authors.lastname: Farrerons
authors.forename: Kim
authors.initials: K
authors.lastname: Brixen
authors.forename: Javier
authors.initials: J
authors.lastname: del Pino
authors.forename: Richard
authors.initials: R
authors.lastname: Keen
authors.forename: Thomas N
authors.initials: TN
authors.lastname: Nickelsen
mesh_terms: D000368:Aged; D001416:Back Pain / Q000188:drug therapy* / Q000209:etiology; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D002118:Calcium / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy*; D010147:Pain Measurement; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage*; D016103:Spinal Fractures / Q000188:drug therapy / Q000209:etiology; D019379:Teriparatide / Q000008:administration & dosage*; D016896:Treatment Outcome; D014807:Vitamin D / Q000008:administration & dosage
chemical_list: D050071:Bone Density Conservation Agents; D019379:Teriparatide; D014807:Vitamin D; D020849:Raloxifene Hydrochloride; D002118:Calcium