Re-treatment of Patients With Paget's Disease Using Zoledronic Acid
Re-treatment of Patients With Paget's Disease Using Zoledronic Acid
The purpose of this study is to demonstrate that patients with Paget's disease of the bone
 who had responded to zoledronic acid treatment as participants in the core registration
 studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully
 treated with a 5mg infusion of zoledronic acid.
Uncontrolled study
Inclusion Criteria:

 -  Written Informed Consent

 -  Patients with Paget's disease randomized to the zoledronic acid arm from the
 CZOL446K2304 and CZOL446K2305 core studies and who were responders by 6 months

 -  Confirmed relapse of Paget's disease of bone (i.e. SAP above ULN, bone scan, worsening
 clinical symptoms)

 Exclusion Criteria:

 -  A patient previously treated with zoledronic acid who relapsed and was retreated with
 anti-resorptive bisphosphonate or calcitonin therapy within the last 12 months

 -  Bisphosphonate Hypersensitivity

 -  Patients with suspected/proven metastases at re-treatment

 -  Calculated creatinine clearance <35 mL/min at screening

 -  Serum calcium level <2.07 mmol/L at screening

 -  Active primary hyperparathyroidism, hyperparathyroidism, hypoparathyroidism or
 hypothyroidism

 Other protocol-defined inclusion/exclusion criteria may apply