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

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00434317

Purpose

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

Condition	Intervention	Phase
Neoplasm Metastasis	Drug: Zolendronic acid	Phase IV

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open-Label Study to Determine the Effect of iv. Zolendronic 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

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Quality of Life assessment at baseline and last visit

Estimated Enrollment:	70
Study Start Date:	August 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 zolendronic acid or other bisphosponates
Pregnancy or lactation

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434317

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CZOL446EHU03
Study First Received:	February 9, 2007
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00434317
Health Authority:	Hungary: Ministry of Health

Keywords provided by Novartis:

Metastasis
Neoplasm
pain

breast cancer
prostate cancer
bone metastasis

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Neoplasm Metastasis
Quality of Life
Breast Neoplasms

Urogenital Neoplasms
Pain
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Neoplasms by Site
Pathologic Processes

ClinicalTrials.gov processed this record on January 13, 2009