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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Diphosphonates; Zoledronic Acid

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