Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer

Urologic Neoplasms Clinical Trial

Official title:

Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00226954
• Other study ID #: PROS0001
• Secondary ID: 78869PROS0001
• Status: Terminated
• Phase: Phase 2
• Start date: March 2003
• Est. completion date: February 2009

Study information

• Verified date: March 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: February 2009
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urologic Neoplasms

Intervention

Drug:
• zoledronic acid

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	To describe the safety and tolerability at this dose and schedule