A Multicenter and Open Label Clinical Trial of Zoledronic Acid 4 mg in Patients with Hypercalcemia of Malignancy

• Published in: Japanese journal of clinical oncology 2005-01, Vol.35 (1), p.28-33
• Main Authors: Kawada, Kenji, Minami, Hironobu, Okabe, Keniichi, Watanabe, Toru, Inoue, Keniichi, Sawamura, Morio, Yagi, Yasuo, Sasaki, Tsuneo, Takashima, Shigemitsu
• Format: Article
• Language: English
• Subjects: Adult; Aged; bisphosphonate; Breast Neoplasms - complications; Calcium - blood; Diphosphonates - administration & dosage; Diphosphonates - therapeutic use; Dose-Response Relationship, Drug; Female; Head and Neck Neoplasms - complications; Humans; hypercalcemia; Hypercalcemia - drug therapy; Hypercalcemia - etiology; Imidazoles - administration & dosage; Imidazoles - therapeutic use; Lung Neoplasms - complications; Male; Middle Aged; Multiple Myeloma - complications; Neoplasms - complications; Treatment Outcome; zoledronic acid
• ISSN: 0368-2811; 1465-3621; 1465-3621
• DOI: 10.1093/jjco/hyi005

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 ≥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 ≤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