title: Loading dose ibandronate versus standard oral ibandronate in patients with bone metastases from breast cancer.
abstract: BACKGROUND
  In this phase II trial, the efficacy and safety of loading-dose I.V. ibandronate in patients with breast cancer with bone metastases were evaluated.
  
  
  METHODS
  Thirty-four patients were randomized to receive a loading dose of 12 mg I.V. ibandronate on day 1 then oral ibandronate 50 mg daily (arm A), or standard oral therapy of 50 mg ibandronate daily from day 1 (arm B). The primary end point was percentage change in serum C-terminal crosslinking telopeptide of type I collagen (S-CTX) from baseline by day 5 of study. Secondary/exploratory end points included percentage change in other bone turnover markers (N-terminal cross-linking telopeptides of type I collagen [NTX], procollagen type I N propeptide, bone alkaline phosphatase) and change in average bone pain score.
  
  
  RESULTS
  There was a significantly greater reduction in S-CTX at day 5 in arm A compared with arm B (median difference, 15.82%; P = .005). There was also a significantly greater reduction in urine NTX/creatinine at day 5 (P = .009) and at the end of weeks 1 to 8 (averaged; P = .006). Average bone pain score was lower in arm A at the end of 8 weeks (P = .012). There were no additional adverse events after administration of 12 mg I.V. loading dose of ibandronate.
  
  
  CONCLUSIONS
  A 12-mg dose of I.V. ibandronate rapidly reduced markers of bone turnover and can be administered without additional toxicity.
authors.affiliation: Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom; Wolfson Wohl Cancer Research Centre, University of Glasgow, United Kingdom.
authors.forename: Iain R
authors.initials: IR
authors.lastname: Macpherson
authors.affiliation: Cancer Research UK, Clinical Trials Unit, University of Glasgow, Glasgow, United Kingdom. Electronic address: caroline.bray@glasgow.ac.uk.
authors.forename: Caroline
authors.initials: C
authors.lastname: Bray
authors.affiliation: Cancer Research UK, Clinical Trials Unit, University of Glasgow, Glasgow, United Kingdom.
authors.forename: Carol
authors.initials: C
authors.lastname: Hopkins
authors.affiliation: Academic Unit of Bone Metabolism, University of Sheffield Clinical Sciences Centre, Sheffield, United Kingdom.
authors.forename: Rosemary A
authors.initials: RA
authors.lastname: Hannon
authors.affiliation: Cancer Research UK, Clinical Trials Unit, University of Glasgow, Glasgow, United Kingdom.
authors.forename: Liz-Anne
authors.initials: LA
authors.lastname: Lewsley
authors.affiliation: Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.
authors.forename: Diana M
authors.initials: DM
authors.lastname: Ritchie
authors.affiliation: Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom. Electronic address: peter.canney@ggc.scot.nhs.uk.
authors.forename: Peter
authors.initials: P
authors.lastname: Canney
mesh_terms: D000284:Administration, Oral; D000368:Aged; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000150:complications / Q000556:secondary*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D024042:Collagen Type I / Q000097:blood / Q000652:urine; D004164:Diphosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D000077557:Ibandronic Acid; D007262:Infusions, Intravenous; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010455:Peptides / Q000097:blood / Q000652:urine
chemical_list: D050071:Bone Density Conservation Agents; D024042:Collagen Type I; D004164:Diphosphonates; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D000077557:Ibandronic Acid
keywords: Bisphosphonate; Bone metastases; Bone turnover markers; Breast cancer; Ibandronate