Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases

J. J. Body, I. J. Diel, M. R. Lichinitser, E. D. Kreuser, W. Dornoff, V. A. Gorbunova, M. Budde, B. Bergström, J. S. de Gréve, I. Mancini, S. Van Belle, F. Cavalli, B. Thuerlimann, R. Herrmann, M. Clemens, W. Eiermann, G. Kaiser, P. Nauen, R. Obenaus, A. E. SchindlerA. Vogt, K. Hoeffken, L. M. Ahlemann, U. Essers, V. G. Porta, J. M. Ferrero, P. Pouillard, A. de Gramont, N. Pinon, S. Reme, J. P. Labat, L. Guillevin, J. F. Morere, C. Krzisch, Z. Mechl, O. Bruland, O. K. Andersen, R. Bremnes, E. P. Ferreira, A. Fernandes, H. Bassara, V. F. Semiglazov, J. Hansen, I. Lorenz, A. Howell, D. Cameron, C. J. Tyrell, T. J. Powels, J. McAleer, P. J. Barrett-Lee, K. Cash, J. Craig, D. A. Decker, R. Gams, R. Gottlieb, R. Gucalp, A. Hage-Boutros, K. Havlin, J. Hon, J. Gale Katterhagen, M. Lewis, T. Panella, P. Plezia, S. Rivkin, J. Sandbach, J. Wade, P. Woolley, P. Conkling, T. J. Ervin, M. Martinez-Rio, D. Tripathy, M. Meshad, J. P. Jordaan, I. D. Werner, G. Falkson

Research output: Contribution to journalArticle

352 Scopus citations


Background: This phase III study compared the efficacy of the new potent bisphosphonate, ibandronate, with placebo as intravenous (i.v.) therapy in metastatic bone disease due to breast cancer. Patients and methods: A total of 466 patients were randomised to receive placebo (n = 158), or 2 mg (n = 154) or 6 mg (n = 154) ibandronate every 3-4 weeks for up to 2 years. The primary efficacy parameter was the number of 12-week periods with new bone complications, expressed as the skeletal morbidity period rate (SMPR). Bone pain, analgesic use and safety were evaluated monthly. Results: SMPR was lower in both ibandronate groups compared with the placebo group; the difference was statistically significant for the ibandronate 6 mg group (P = 0.004 versus placebo). Consistent with the SMPR, ibandronate 6 mg significantly reduced the number of new bone events (by 38%) and increased time to first new bone event. Patients on ibandronate 6 mg also experienced decreased bone pain scores and analgesic use. Treatment with ibandronate was well tolerated. Conclusions: These results indicate that 6 mg i.v. ibandronate is effective and safe in the treatment of bone metastases from breast cancer.

Original languageEnglish (US)
Pages (from-to)1399-1405
Number of pages7
JournalAnnals of Oncology
Issue number9
StatePublished - Sep 1 2003



  • Bisphosphonate
  • Bone metastases
  • Breast cancer
  • Ibandronate
  • Pain
  • Radiotherapy

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

Body, J. J., Diel, I. J., Lichinitser, M. R., Kreuser, E. D., Dornoff, W., Gorbunova, V. A., Budde, M., Bergström, B., de Gréve, J. S., Mancini, I., Van Belle, S., Cavalli, F., Thuerlimann, B., Herrmann, R., Clemens, M., Eiermann, W., Kaiser, G., Nauen, P., Obenaus, R., ... Falkson, G. (2003). Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases. Annals of Oncology, 14(9), 1399-1405.