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

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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Key information

Conditions

Neoplasm Metastasis Breast Diseases Breast Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Neoplastic Processes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Budapest, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zoledronic acid

Drug

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Multicenter, Open-label Study to Determine the Effect of iv. Zoledronic Acid on Pain and Quality of Life in Patients With Bone Metastases With or Without Skeletal Related Events (SRE) Resulting From Breast Cancer and Prostate Cancer

Important dates

Study start: 2005
Primary completion: 2008
First posted: Feb 13, 2007
Registry last updated: Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed