Document Detail


A multicenter and open label clinical trial of zoledronic acid 4 mg in patients with hypercalcemia of malignancy.
MedLine Citation:
PMID:  15681601     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
Kenji Kawada; Hironobu Minami; Keniichi Okabe; Toru Watanabe; Keniichi Inoue; Morio Sawamura; Yasuo Yagi; Tsuneo Sasaki; Shigemitsu Takashima
Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  Japanese journal of clinical oncology     Volume:  35     ISSN:  0368-2811     ISO Abbreviation:  Jpn. J. Clin. Oncol.     Publication Date:  2005 Jan 
Date Detail:
Created Date:  2005-01-31     Completed Date:  2005-03-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0313225     Medline TA:  Jpn J Clin Oncol     Country:  Japan    
Other Details:
Languages:  eng     Pagination:  28-33     Citation Subset:  IM    
Affiliation:
Department of Oncology/Hematology, National Cancer Center Hospital East, Kashiwa, Chiba 277-8577, Japan.
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Breast Neoplasms / complications
Calcium / blood
Diphosphonates / administration & dosage,  therapeutic use*
Dose-Response Relationship, Drug
Female
Head and Neck Neoplasms / complications
Humans
Hypercalcemia / drug therapy*,  etiology
Imidazoles / administration & dosage,  therapeutic use*
Lung Neoplasms / complications
Male
Middle Aged
Multiple Myeloma / complications
Neoplasms / complications*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Diphosphonates; 0/Imidazoles; 118072-93-8/zoledronic acid; 7440-70-2/Calcium

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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