Zoledronic Acid Is Superior To Pamidronate in The Treatment of Hypercalcemia of Malignancy: A Pooled Analysis of Two Randomized, Controlled Clinical Trials - PubMed

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Zoledronic acid is superior to pamidronate in the treatment of hypercal… pooled analysis of two randomized, controlled clinical trials - PubMed

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Meta-Analysis J Clin Oncol. 2001 Jan 15;19(2):558-67. doi: 10.1200/JCO.2001.19.2.558.

Zoledronic acid is superior to pamidronate in the


treatment of hypercalcemia of malignancy: a pooled
analysis of two randomized, controlled clinical trials
P Major 1 , A Lortholary, J Hon, E Abdi, G Mills, H D Menssen, F Yunus, R Bell, J Body,
E Quebe-Fehling, J Seaman

Affiliations
PMID: 11208851 DOI: 10.1200/JCO.2001.19.2.558

Abstract
Purpose: Two identical, concurrent, parallel, multicenter, randomized, double-blind, double-
dummy trials were conducted to compare the efficacy and safety of zoledronic acid and
pamidronate for treating hypercalcemia of malignancy (HCM).

Patients and methods: Patients with moderate to severe HCM (corrected serum calcium [CSC] >
or = 3.00 mmol/L [12.0 mg/dL]) were treated with a single dose of zoledronic acid (4 or 8 mg) via 5-
minute infusion or pamidronate (90 mg) via 2-hour infusion. A protocol-specified pooled analysis of
the two parallel trials was performed. Clinical end points included rate of complete response by day
10, response duration, and time to relapse.

Results: Two hundred eighty-seven patients were randomized and evaluated for safety; 275 were
evaluated for efficacy. Both doses of zoledronic acid were superior to pamidronate in the treatment
of HCM. The complete response rates by day 10 were 88.4% (P = .002), 86.7% (P = .015), and
69.7% for zoledronic acid 4 mg and 8 mg and pamidronate 90 mg, respectively. Normalization of
CSC occurred by day 4 in approximately 50% of patients treated with zoledronic acid and in only
33.3% of the pamidronate-treated patients. The median duration of complete response favored
zoledronic acid 4 and 8 mg over pamidronate 90 mg with response durations of 32, 43, and 18
days, respectively.

Conclusion: Zoledronic acid is superior to pamidronate; 4 mg is the dose recommended for initial
treatment of HCM and 8 mg for relapsed or refractory hypercalcemia.

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