title: Phase II study of loading-dose ibandronate treatment in patients with breast cancer and bone metastases suffering from moderate to severe pain.
abstract: BACKGROUND
  The aim of this study was to determine the efficacy and safety of loading-dose intravenous (i.v.) ibandronate in women with breast cancer and bone metastases.
  
  
  METHODS
  In this prospective, phase II, open-label study, 13 women with breast cancer, bone metastases, and moderate/severe bone pain received ibandronate 6 mg/day (i.v. loading-dose 15 min infusion over 3 consecutive days) with follow-up until day 14. Endpoints included pain response (primary), duration until pain response, analgesic use, Karnofsky index, safety (including hematologic, biochemical, and urine examinations), and adverse events.
  
  
  RESULTS
  Pain intensity decreased on days 7 and 14 versus day 1 (mean visual analogue scale score: 3.2 ± 2.2 and 3.0 ± 2.1 versus 6.1 ± 0.9, respectively; p < 0.01 for both). Mean time to pain response was 8.2 ± 3.3 days. Mean rate of analgesic use decreased (69.2%, 16.7% and 15.4% on days 1, 7 and 14, respectively). Mean Karnofsky index score increased (80.8 ± 13.1 and 80.8 ± 13.2, on days 7 and 14 versus 77.7 ± 11.7 on day 1; p < 0.05 on both days).
  
  
  CONCLUSIONS
  Bone pain and analgesic use decreased in women with breast cancer and bone metastases following loading dose i.v. ibandronate which was well-tolerated with no renal safety concerns.
authors.affiliation: Medical Oncology Department, Hacettepe University School of Medicine, Sıhhiye, Ankara, Turkey. kaltunda@hacettepe.edu.tr
authors.forename: Kadri
authors.initials: K
authors.lastname: Altundag
authors.forename: Omer
authors.initials: O
authors.lastname: Dizdar
authors.forename: Zeynep
authors.initials: Z
authors.lastname: Ozsaran
authors.forename: Serdar
authors.initials: S
authors.lastname: Ozkok
authors.forename: Pinar
authors.initials: P
authors.lastname: Saip
authors.forename: Yesim
authors.initials: Y
authors.lastname: Eralp
authors.forename: Seref
authors.initials: S
authors.lastname: Komurcu
authors.forename: Okan
authors.initials: O
authors.lastname: Kuzhan
authors.forename: Mustafa
authors.initials: M
authors.lastname: Ozguroglu
authors.forename: Metin
authors.initials: M
authors.lastname: Karahoca
mesh_terms: D050071:Bone Density Conservation Agents / Q000008:administration & dosage; D001859:Bone Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000556:secondary*; D001943:Breast Neoplasms / Q000150:complications / Q000188:drug therapy*; D004164:Diphosphonates / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D000077557:Ibandronic Acid; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D008875:Middle Aged; D010146:Pain / Q000209:etiology / Q000517:prevention & control*; D010147:Pain Measurement / Q000187:drug effects; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D000077557:Ibandronic Acid