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JAMA. 2001;286:1569.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has approved zoledronic acid for injection (Zometa; Novartis Pharmaceutical Corp, East Hanover, NJ), an inhibitor of osteoclastic bone resorption, for the treatment of hypercalcemia of malignancy (HCM).

The product was approved on the basis of two identical multicenter, randomized, double-blind, double-dummy trials of Zometa, 4 mg given as a 5-minute intravenous infusion, or pamidronate, 90 mg given as a 2-hour intravenous infusion, in 185 patients with HCM. Patients with recalcitrant or recurrent hypercalcemia received a second dose of Zometa.

The treatment groups were generally well balanced with regard to age, sex, race, and tumor type. The most common tumor types were lung, breast, head/neck, and renal.

In these studies, HCM was defined as a corrected serum calcium (CSC) concentration of 12.0 mg/dL (3.00 mmol/L). The primary efficacy variable was the proportion of patients having a complete response, defined as lowering of the CSC to 10.8 mg/dL (2.70 mmol/L) . . . [Full Text of this Article]

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