Safety and pain palliation of zoledronic acid in patients with breast cancer, prostate cancer, or multiple myeloma who previously received bisphosphonate therapy

Oncologist. 2004;9(6):687-95. doi: 10.1634/theoncologist.9-6-687.


An open-label study conducted in community centers assessed the safety of zoledronic acid 4 mg intravenously over 15 minutes every 3-4 weeks as treatment of bone metastases in patients with multiple myeloma, breast cancer, or prostate cancer with and without previous bisphosphonate exposure. Adverse events (AEs), pain, and quality-of-life (QOL) scores were recorded, and serum creatinine (SCr) levels were measured before each infusion. Of 638 patients, 415 patients (65%) had received prior bisphosphonate therapy. Fatigue, nausea, and arthralgia were the most frequent AEs. Nausea was more common in bisphosphonate-naive patients. SCr levels increased notably in 6.6% of patients: 7.7% of patients who received prior bisphosphonate therapy and 4.5% of bisphosphonate-naive patients. Treatment was delayed because of SCr-level increases in 1.4% of patients with prior bisphosphonate exposure and 0.4% of bisphosphonate-naive patients. SCr-level increases and treatment delays did not correlate with duration of prior bisphosphonate therapy. There was a trend towards more treatment discontinuations in patients with prior bisphosphonate exposure compared with bisphosphonate-naive patients. Pain scores decreased from baseline; total QOL scores remained constant. The results of this study suggest that, with proper SCr-level monitoring, cancer patients with bone metastases who have previously received intravenous bisphosphonate treatment can be safely converted to zoledronic acid therapy.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Arthralgia / chemically induced
  • Bone Neoplasms / drug therapy*
  • Bone Neoplasms / secondary*
  • Bone Resorption / prevention & control
  • Breast Neoplasms / drug therapy
  • Breast Neoplasms / pathology
  • Creatinine / blood
  • Diphosphonates / therapeutic use*
  • Fatigue / chemically induced
  • Female
  • Humans
  • Imidazoles / therapeutic use*
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Multiple Myeloma / drug therapy
  • Multiple Myeloma / pathology
  • Nausea / chemically induced
  • Pain / drug therapy*
  • Pain Measurement
  • Prospective Studies
  • Prostatic Neoplasms / drug therapy
  • Prostatic Neoplasms / pathology
  • Quality of Life
  • Treatment Outcome
  • Zoledronic Acid


  • Diphosphonates
  • Imidazoles
  • Zoledronic Acid
  • Creatinine