Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00226954 |
Recruitment Status
:
Completed
First Posted
: September 27, 2005
Last Update Posted
: July 28, 2009
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Urologic Neoplasms | Drug: zoledronic acid | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
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 |
Study Start Date : | March 2003 |
Actual Primary Completion Date : | November 2007 |
Actual Study Completion Date : | February 2009 |

- To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.
- To describe the safety and tolerability at this dose and schedule

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

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
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Dr. Sandy Srinivas | Stanford University |
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 Posted: | September 27, 2005 Key Record Dates |
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 |