title: Oral ibandronate for the treatment of metastatic bone disease in breast cancer: efficacy and safety results from a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  We report the first results of a randomized trial assessing a new oral aminobisphosphonate, ibandronate, in patients with bone metastases from breast cancer.
  
  
  METHODS
  Patients (n = 435) received placebo, or oral ibandronate 20 mg or 50 mg once-daily for 96 weeks. The primary efficacy measure was the number of 12-week periods with new bone complications [skeletal morbidity period rate (SMPR)]. Multivariate Poisson regression analysis assessed the relative risk reduction of skeletal-related events. Secondary efficacy analyses included bone pain and analgesic use. Adverse events were monitored.
  
  
  RESULTS
  SMPR was significantly reduced with oral ibandronate [placebo 1.2, 20 mg group 0.97 (P = 0.024), 50 mg group 0.98 (P = 0.037)]. Ibandronate 50 mg significantly reduced the need for radiotherapy (P = 0.005 versus placebo). The relative risk of skeletal events was reduced by 38% (20 mg dose) and 39% (50 mg dose) versus placebo (P = 0.009 and P = 0.005). The tolerability profile of ibandronate was similar to placebo.
  
  
  CONCLUSIONS
  Oral ibandronate is an effective and well-tolerated treatment for metastatic bone disease. The 50 mg dose is being further evaluated in clinical trials, and this dose was recently approved in the European Union for the prevention of skeletal events in patients with breast cancer and bone metastases.
authors.affiliation: University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-8852, USA. debu.tripathy@utsouthwestern.edu
authors.forename: D
authors.initials: D
authors.lastname: Tripathy
authors.forename: M
authors.initials: M
authors.lastname: Lichinitzer
authors.forename: A
authors.initials: A
authors.lastname: Lazarev
authors.forename: S A
authors.initials: SA
authors.lastname: MacLachlan
authors.forename: J
authors.initials: J
authors.lastname: Apffelstaedt
authors.forename: M
authors.initials: M
authors.lastname: Budde
authors.forename: B
authors.initials: B
authors.lastname: Bergstrom
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000627:therapeutic use; D001859:Bone Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000556:secondary*; D001943:Breast Neoplasms / Q000473:pathology*; D004164:Diphosphonates / Q000008:administration & dosage* / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077557:Ibandronic Acid; D008875:Middle Aged; D009017:Morbidity; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D010919:Placebos
chemical_list: D000700:Analgesics; D004164:Diphosphonates; D010919:Placebos; D000077557:Ibandronic Acid