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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasm Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZOL446

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

Interventions

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Zoledronic acid

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No