Assessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone Metastases

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

Summary

This study will evaluate the safety, tolerability and efficacy of zoledronic acid administered intravenously every 3-4 weeks in patients with bone metastases from either breast cancer or prostate cancer.

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

Details

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

Criteria

Inclusion criteria:

• Ambulatory patients >18 years

• Proof of breast cancer or prostate cancer

• Diagnosis of at least one cancer-related bone lesion that is detectable on conventional radiographs or bone scan at screening

• Negative pregnancy test

• ECOG performance status of 0,1 or 2

Exclusion criteria:

• Patients with abnormal renal function

• Patients with clinically symptomatic brain metastases

• Known hypersensitivity on zoledronic acid or other bisphosphonates

• Pregnancy or lactation

Other protocol-defined inclusion/exclusion criteria may apply.