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

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

Official Title

A Phase IV Study of Zoledronic Acid Therapy in Patients With Bone Metastases From Breast Cancer or Hormone Resistant Prostate Cancer, or Bone Involvement From Multiple Myeloma, Assessing Long-Term Efficacy and Safety

Conditions

Bone Neoplasms

Study Type

Interventional

Study Design

Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures: Safety assessed by incidence of renal impairment, osteonecrosis of the Jaw (ONJ), adverse events and serious adverse events. Efficacy assessed by incidence of skeletal related events (SREs).

Study Start

December 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

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

Total Enrolment

200

Contact Details

• Canberra, Australian Capital Territory, Australia; Recruiting
• Concord, New South Wales, Australia; Recruiting
• Liverpool, New South Wales, Australia; Recruiting
• Wagga Wagga, New South Wales, Australia; Recruiting
• Redcliffe, Queensland, Australia; Recruiting
• Townsville, Queensland, Australia; Recruiting
• Woolloongabba, Queensland, Australia; Recruiting
• Box Hill, Victoria, Australia; Recruiting
• Frankston, Victoria, Australia; Recruiting
• Ballarat, Victoria, Australia; Recruiting

Contact Novartis Australia for more information (refer to this study by ClinicalTrials.gov identifier NCT00434447)