Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00226954
First received: September 13, 2005
Last updated: July 27, 2009
Last verified: July 2009

September 13, 2005
July 27, 2009
March 2003
November 2007   (final data collection date for primary outcome measure)
To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.
Same as current
Complete list of historical versions of study NCT00226954 on ClinicalTrials.gov Archive Site
To describe the safety and tolerability at this dose and schedule
Same as current
Not Provided
Not Provided
 
Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer
Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Urologic Neoplasms
Drug: zoledronic acid
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2009
November 2007   (final data collection date for primary outcome measure)

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: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

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00226954
PROS0001, 78869, PROS0001
Not Provided
Dr. Sandy Srinivas, Principal Investigator, Stanford University School of Medicine
Stanford University
Novartis
Principal Investigator: Dr. Sandy Srinivas Stanford University
Stanford University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP