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

Novartis80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasm Metastasis

Interventions

Zoledronic acidDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Pécs, Hungary

Novartis Investigative Site

Szeged, Hungary

Novartis Investigative Site

Székesfehérvár, Hungary

Outcomes

Primary Outcomes

Measurement of pain assessed by a Visual Analogue Scale (VAS)

Time frame: throughout the study

Secondary Outcomes

Quality of Life assessment at baseline and last visit

Time frame: throughout the study

Data from ClinicalTrials.gov

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