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Randomized Controlled Trial
. 2008 Mar 31:8:2.
doi: 10.1186/1472-6904-8-2.

Renal safety of zoledronic acid with thalidomide in patients with myeloma: a pharmacokinetic and safety sub-study

Andrew Spencer  1 , Andrew Roberts, Nola Kennedy, Christina Ravera, Serge Cremers, Sanela Bilic, Terry Neeman, Michael Copeman, Horst Schran, Kevin Lynch
Affiliations
Randomized Controlled Trial

Renal safety of zoledronic acid with thalidomide in patients with myeloma: a pharmacokinetic and safety sub-study

Andrew Spencer et al. BMC Clin Pharmacol. .

Abstract

Background: Cases of impaired renal function have been reported in patients who had been treated with both zoledronic acid and thalidomide for myeloma. Hence, we conducted a safety study of zoledronic acid and thalidomide in myeloma patients participating in a trial of maintenance therapy.

Methods: Twenty-four patients who were enrolled in a large randomized trial of thalidomide vs no thalidomide maintenance therapy for myeloma, in which all patients also received zoledronic acid, were recruited to a pharmacokinetic and renal safety sub-study, and followed for up to 16 months.

Results: No significant differences by Wilcoxon rank-sum statistic were found in zoledronic acid pharmacokinetics or renal safety for up to 16 months in patients randomized to thalidomide or not.

Conclusion: In myeloma patients receiving maintenance therapy, the combination of zoledronic acid and thalidomide appears to confer no additional renal safety risks over zoledronic acid alone.

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Figures

Figure 1
Figure 1
a: Means (± standard deviation) of plasma concentrations of zoledronic acid after 1st infusion in Arm1 (n = 11) patients who received zoledronic acid, thalidomide and prednisolone. b: Means (± standard deviation) of plasma concentrations of zoledronic acid after 1st infusion in Arm2 (n = 12) patients who received zoledronic acid alone.
Figure 2
Figure 2
Means (± standard deviations) of serum creatinines prior to (up to 16) infusions of zoledronic acid in patients on Arm1 (diamonds) [receiving zoledronic acid, thalidomide and prednisolone] and Arm 2 (triangles) [receiving zoledronic acid alone]. Numbers of patients receiving each infusion are also shown, by reference to the scale on the right side.
See this image and copyright information in PMC

References

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