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Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Natural history/Epidemiology, Treatment

Active

18 and over

Pharmaceutical / Industry

CZOL446EAU22
NCT00434447

Trial Description

Summary

This study is designed to monitor the safety and efficacy of long-term treatment with zoledronic acid by assessing the incidence of, renal impairment, osteonecrosis of the jaw(ONJ), overall safety and skeletal related events (SREs) beyond 12 months treatment

Eligibility Criteria

Inclusion criteria:

Documented bone metastases from breast cancer, prostate cancer or multiple myeloma

Prior treatment with zoledronic acid for 1-2 yrs

Life expectancy of at least 6 months

Exclusion criteria:

Prior treatment with bisphosphonates other than zoledronic acid

Abnormal kidney function

Current or previous dental problems or planned dental surgery

Pregnant or likely to become pregnant during the study

Other protocol-defined inclusion/exclusion criteria may apply

Trial Contact Information

Trial Lead Organizations/Sponsors

Novartis Pharmaceuticals Corporation

Novartis

Study Chair

Novartis Basel

Ph: 41 61 324 111

Trial Sites

Australia

Australian Capital Territory

Canberra

Study Site

New South Wales

Concord

Study Site

Liverpool

Study Site

Wagga Wagga

Study Site

Queensland

Redcliffe

Study Site

Townsville

Study Site

Woolloongabba

Study Site

Victoria

Ballarat

Study Site

Box Hill

Study Site

Frankston

Study Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00434447
Information obtained from ClinicalTrials.gov on May 27, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.