Re-treatment of relapsed Paget's disease of bone with zoledronic acid: results from an open-label study

Abstract

Six patients from the phase 3 trials of zoledronic acid in Paget's disease, who had received zoledronic acid initially and had subsequently relapsed, were entered into an open re-treatment study. Following re-treatment, each patient reached similar absolute nadirs of serum alkaline phosphatase to those recorded after their first dose. No significant adverse events were reported. It is concluded that, while re-treatment of Paget's disease with zoledronic acid is rarely needed, it is safe and effective, with no evidence of treatment resistance based on this small cohort.

Conflict of interest statement

IRR has acted as a consultant for Novartis. GS, OA-F and RPA are Novartis employees. The remaining authors declare no conflict of interest.

Figures

Figure 1

Individual patient data for serum total ALP from the initiation of the core studies. All subjects received an infusion of zoledronic acid 5 mg at month 0, and again at the beginning of the re-treatment period. Data from the 6-month core study and the subsequent open observation period are shown with solid lines. Data for the 6-month re-treatment period are shown with broken lines. The re-treatment data for patient 2 are shown between months 63 and 69, overlapping the post-trial observation period for the other patients. The reference range for ALP is 31–110 U l−1.

Figure 2

Effect of re-treatment with zoledronic acid on serum total ALP at months 3 and 6. Data are shown as mean±s.e. (n=6).