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Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00226954
First Posted: September 27, 2005
Last Update Posted: July 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by:
Stanford University
  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
Urologic Neoplasms Drug: zoledronic acid Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer

Resource links provided by NLM:


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
Study Completion Date: February 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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: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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226954


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Novartis
Investigators
Principal Investigator: Dr. Sandy Srinivas Stanford University
  More Information

Responsible Party: Dr. Sandy Srinivas, Principal Investigator, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00226954     History of Changes
Other Study ID Numbers: PROS0001
78869
First Submitted: September 13, 2005
First Posted: September 27, 2005
Last Update Posted: July 28, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Prostatic Neoplasms
Urologic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs