title: Zoledronic acid versus pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: a phase III, double-blind, comparative trial.
abstract: OBJECTIVE
  Zoledronic acid, a new and more potent bisphosphonate, was compared with pamidronate, the current standard treatment for patients with osteolytic or mixed bone metastases/lesions.
  
  
  METHODS
  A total of 1,648 patients with either Durie-Salmon stage III multiple myeloma or advanced breast cancer and at least one bone lesion were randomly assigned to treatment with either 4 or 8 mg of zoledronic acid via 15-minute intravenous infusion or 90 mg of pamidronate via 2-hour intravenous infusion every 3 to 4 weeks for 12 months. The primary efficacy endpoint was the proportion of patients experiencing at least one skeletal-related event over 13 months.
  
  
  RESULTS
  The proportion of patients with at least one skeletal-related event was similar in all treatment groups. Median time to the first skeletal-related eventwas approximately 1 year in each treatment group. The skeletal morbidity rate was slightly lower in patients treated with zoledronic acid than in those treated with pamidronate, and zoledronic acid (4 mg) significantly decreased the incidence and event rate for radiation therapy to bone, both overall and in breast cancer patients receiving hormonal therapy. Pain scores decreased in all treatment groups in the presence of stable or decreased analgesic use. Zoledronic acid (4 mg) and pamidronate were equally well tolerated; the most common adverse events were bone pain, nausea, fatigue, and fever and < 5% of serious adverse events were related to the study drug. The incidence of renal impairment among patients treated with 4 mg of zoledronic acid via 15-minute infusion was similar to that among patients treated with pamidronate.
  
  
  CONCLUSIONS
  Zoledronic acid (4 mg) via 15-minute intravenous infusion was as effective and well tolerated as 90 mg of pamidronate in the treatment of osteolytic and mixed bone metastases/lesions in patients with advanced breast cancer or multiple myeloma. (Can-
authors.affiliation: Jonsson Cancer Center, University of California, Los Angeles 90095, USA.
authors.forename: L S
authors.initials: LS
authors.lastname: Rosen
authors.forename: D
authors.initials: D
authors.lastname: Gordon
authors.forename: M
authors.initials: M
authors.lastname: Kaminski
authors.forename: A
authors.initials: A
authors.lastname: Howell
authors.forename: A
authors.initials: A
authors.lastname: Belch
authors.forename: J
authors.initials: J
authors.lastname: Mackey
authors.forename: J
authors.initials: J
authors.lastname: Apffelstaedt
authors.forename: M
authors.initials: M
authors.lastname: Hussein
authors.forename: R E
authors.initials: RE
authors.lastname: Coleman
authors.forename: D J
authors.initials: DJ
authors.lastname: Reitsma
authors.forename: J J
authors.initials: JJ
authors.lastname: Seaman
authors.forename: B L
authors.initials: BL
authors.lastname: Chen
authors.forename: Y
authors.initials: Y
authors.lastname: Ambros
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D001943:Breast Neoplasms / Q000473:pathology*; D004164:Diphosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009101:Multiple Myeloma / Q000473:pathology*; D000077268:Pamidronate; D000077211:Zoledronic Acid
chemical_list: D000970:Antineoplastic Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid; D000077268:Pamidronate