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

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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