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

Novartis

Status and phase: Completed; Phase 4

Conditions: Neoplasm Metastasis

Treatments: Drug: Zoledronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00434317

CZOL446EHU03

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

ZOL446

Experimental group

Treatment:

Drug: Zoledronic acid