Re-treatment of Participants With Paget's Disease Using Zoledronic Acid

Novartis

Status and phase

Completed

Phase 4

Conditions

Paget's Disease of the Bone

Treatments

Drug: Zoledronic Acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00740129

CZOL446K2418

2008-002898-12 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study was to demonstrate that participants 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 5 milligram (mg) infusion of zoledronic acid.

Full description

Uncontrolled study

Enrollment

6 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Written Informed Consent
Participants 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., serum alkaline phosphatase (SAP) above upper limit of normal (ULN), bone scan, worsening clinical symptoms)

Exclusion criteria

A participant previously treated with zoledronic acid who relapsed and was retreated with anti-resorptive bisphosphonate or calcitonin therapy within the last 12 months
Bisphosphonate Hypersensitivity
Participants with suspected/proven metastases at re-treatment
Calculated creatinine clearance <35 milliliter/minute (mL/min) at screening
Serum calcium level <2.07 millimole/liter (mmol/L) at screening
Active primary hyperparathyroidism, hyperparathyroidism, hypoparathyroidism or hypothyroidism

Other protocol-defined inclusion/exclusion criteria may apply.