Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer

Phase 2

Terminated

• Conditions: Urologic Neoplasms
• Interventions: Drug: zoledronic acid

• Registration Number: NCT00226954
• Lead Sponsor: Stanford University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-23
• Study First Posted: 2005-09-27
• Primary Completion: 2007-11
• Study Completion: 2009-02
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zoledronic Acid with Intermittent Hormonal Therapy	zoledronic acid	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To describe the safety and tolerability at this dose and schedule

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States