title: A multicenter and open label clinical trial of zoledronic acid 4 mg in patients with hypercalcemia of malignancy.
abstract: BACKGROUND
  Hypercalcemia of malignancy is a serious complication of cancer. The objective of this study was to investigate the efficacy and safety of zoledronic acid, a new-generation bisphosphonate and the most potent inhibitor of bone resorption identified to date, for hypercalcemia of malignancy in Japanese patients.
  
  
  METHODS
  Patients with hypercalcemia of malignancy, defined as an albumin-corrected serum calcium level > or =12.0 mg/dl, were treated with a single dose of zoledronic acid, 4 mg, by 15 min infusion. Clinical end-points included the proportion of patients with complete response, which was defined as a decrease of corrected serum calcium < or =10.8 mg/dl by day 10, and time to relapse, which is defined as the duration in days between the date of infusion and last available corrected serum calcium <11.6 mg/dl.
  
  
  RESULTS
  Twenty-seven patients were enrolled in this study and 25 patients were evaluable for the efficacy of zoledronic acid. The mean corrected serum calcium level decreased from 14.5 to 9.6 mg/dl by day 10. The complete response rate was 84%. The median time to relapse was 23 days, ranging from 0 to 56 days. The most frequently observed adverse event was fever (< or =38 degrees C). Electrolyte abnormalities suspected to be drug related including grade 3 or 4 hypocalcemia, hypophosphatemia and hypokalemia were observed in 11 patients; however, all patients were asymptomatic. No serious adverse events associated with renal toxicity were reported.
  
  
  CONCLUSIONS
  Zoledronic acid is well tolerated and is effective for hypercalcemia of malignancy in Japanese patients.
authors.affiliation: Department of Oncology/Hematology, National Cancer Center Hospital East, Kashiwa, Chiba 277-8577, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Kawada
authors.forename: Hironobu
authors.initials: H
authors.lastname: Minami
authors.forename: Keniichi
authors.initials: K
authors.lastname: Okabe
authors.forename: Toru
authors.initials: T
authors.lastname: Watanabe
authors.forename: Keniichi
authors.initials: K
authors.lastname: Inoue
authors.forename: Morio
authors.initials: M
authors.lastname: Sawamura
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Yagi
authors.forename: Tsuneo
authors.initials: T
authors.lastname: Sasaki
authors.forename: Shigemitsu
authors.initials: S
authors.lastname: Takashima
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000150:complications; D002118:Calcium / Q000097:blood; D004164:Diphosphonates / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006258:Head and Neck Neoplasms / Q000150:complications; D006801:Humans; D006934:Hypercalcemia / Q000188:drug therapy* / Q000209:etiology; D007093:Imidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000150:complications; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications; D009369:Neoplasms / Q000150:complications*; D016896:Treatment Outcome; D000077211:Zoledronic Acid
chemical_list: D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid; D002118:Calcium