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Abstract

Aim: This study aims to determine the adverse effect profile of intravenous (IV) zoledronic acid in cancer patients with skeletal metastasis. Materials and Methods: A prospective longitudinal study was conducted at a cancer specialty hospital and research center, Bengaluru, for a period of 6 months. A total of 80 subjects receiving the first dose of zoledronic acid 4 mg 3 weekly regimens were enrolled and followed up. However, there were seven dropouts. Primary end point was to determine the difference in proportions of developing renal toxicity using relative risk (RR). Secondary end point was to compare baseline with post-treatment serum calcium values using paired t-test analysis. Suspected acute-phase reactions (APRs) were subjected to causality (WHO scale) and severity (Hartwig and Siegel scale) assessment. Results: Significant elevation in serum creatinine indicates higher risk of renal toxicity (RR = 1.625) at 95% confidence interval (CI) (1.134–2.330). Statistically significant decrease in serum calcium was determined in the patients treated with IV zoledronic acid (P = 0.00) at 95% CI indicating the therapeutic efficacy. Thirty-one patients experienced adverse drug reactions with probable causal relationship, the commonly reported APRs being flu-like symptoms (48.8%). Severity of the suspected APRs was mild to moderate. Hence, discontinuation of zoledronic acid was not needed. Conclusion: A single dose 4 mg IV infusion of zoledronic acid is effective and safe in patients with skeletal metastasis. Due to its effectiveness in increasing bone mineral density, it can be the drug of choice in preventing fractures, osteoporosis, and hematological malignancy including lymphoma and multiple myeloma other than breast cancer with skeletal metastasis.

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	JPR Solutions

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