Study of Zoledronic Acid for Patients With Hormone-Sensitive Bone Metastases From Prostate Cancer

This study is currently recruiting participants.

Verified by Novartis, May 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00242567

Purpose

This study aims to determine whether early treatment with zoledronic acid, that is given during the early phase of advanced prostate cancer, will be more efficacious than delayed treatment

Condition	Intervention	Phase
Prostate Cancer	Drug: Zoledronic Acid	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study of Zoledronic Acid for Patients With Hormone-Sensitive Bone Metastases From Prostate Cancer

Further study details as provided by Novartis:

Primary Outcome Measures:

To compare skeletal-event-free survival at 18 months in men with bone metastases from prostate cancer

Secondary Outcome Measures:

To compare overall survival, SRE-free survival and multiple-event analysis of skeletal-related events (SRE's) and other adverse events in the two groups of patients over 3 years

Estimated Enrollment:	550
Study Start Date:	October 2005

Eligibility

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

Criteria

Inclusion Criteria:

prostate cancer
at least one bone metastasis
receiving or about to receive androgen deprivation therapy (ADT)

Exclusion Criteria:

previous ADT failure
previous or current treatment with another bone-protecting agent, chemotherapy or targeted therapy
abnormal renal function

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242567

Contacts

Contact: Novartis

+41 61 324 1111

Locations

Australia
	Recruiting
multiple locations, Australia
Brazil
	Not yet recruiting
multiple locations, Brazil
China
	Recruiting
multiple locations, China
New Zealand
	Recruiting
multiple locations, New Zealand
Taiwan
	Not yet recruiting
multiple locations, Taiwan
Thailand
	Recruiting
multiple locations, Thailand

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CZOL446E2432
Study First Received:	October 19, 2005
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00242567
Health Authority:	Thailand: Food and Drug Administration

Keywords provided by Novartis:

zoledronic acid
bone metastases
prostate cancer
hormone-sensitive

Study placed in the following topic categories:

Diphosphonates
Zoledronic acid
Prostatic Diseases
Genital Neoplasms, Male

Neoplasm Metastasis
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009