Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer

This study is currently recruiting participants.

Verified by Stanford University, May 2007

Sponsors and Collaborators:	Stanford University Novartis
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00226954

Purpose

Primary:

To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.

Secondary Objectives:

To describe the safety and tolerability at this dose and schedule

Condition	Intervention	Phase
Prostate Cancer	Drug: zoledronic acid	Phase II

MedlinePlus related topics: Cancer Minerals Prostate Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
Official Title:	Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer

Further study details as provided by Stanford University:

Primary Outcome Measures:

To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.

Secondary Outcome Measures:

To describe the safety and tolerability at this dose and schedule

Estimated Enrollment:	30
Study Start Date:	March 2003

Eligibility

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

Criteria

Inclusion Criteria: Patients: Who are 18 years of age and older Who have histologically documented adenocarcinoma of prostate Who are currently receiving LHRH agonists KPS greater than 80%Life expectancy greater than 6 months Provide written consent pursuant to regulatory requirements prior to initiation of study procedure

Exclusion Criteria: Patients: Any patient requiring continuous LHRH Any patient who has had an orchiectomy Any patient with painful bone metastases Who have received chemotherapy for prostate cancer Who have a abnormal serum creatine >2.5 Receiving any investigational drug within the last 28 days Severe uncontrolled infection, diabetes, cardiac disease Patients with fragility fractures, hyperparathyroidism, Pagets renal osteodystrophy will be excluded History of non compliance to medical regimens or unwillingness to return for medical visits

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226954

Contacts

Contact: Denise Haas

650-736-1252

dhaas@stanford.edu

Locations

United States, California
Stanford University Cancer Center	Recruiting
Stanford, California, United States, 94305
Contact: Cancer Clinical Trials Office 650-498-7061

Sponsors and Collaborators

Stanford University

Novartis

Investigators

Principal Investigator:

Sandy Srinivas, MD

Stanford University

More Information

Study ID Numbers:	PROS0001
Study First Received:	September 13, 2005
Last Updated:	May 31, 2007
ClinicalTrials.gov Identifier:	NCT00226954
Health Authority:	United States: Food and Drug Administration

Keywords provided by Stanford University:

Prostate Cancer

Study placed in the following topic categories:

Diphosphonates
Zoledronic acid
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009