Effect of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastasis

Phase 4

Completed

• Conditions: Prostate Cancer Patients With Bone Metastasis
• Interventions: Drug: Zoledronic acid

• Registration Number: NCT00237159
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

It is the aim of this clinical study to evaluate the skeletal-related event rate and tolerability of zoledronic acid in patients with prostate cancer patients and bone metastases.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2005-10-09
• Study First Submitted QC: 2005-10-09
• Study First Posted: 2005-10-12
• Primary Completion: 2005-12
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-21
• Last Update Posted: 2011-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 284

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZOL446	Zoledronic acid	-

Primary Outcome Measures

Name	Time	Method
Rate of skeletal complications	3 months

Secondary Outcome Measures

Name	Time	Method
Time to first skeletal complication	3 months
Bone pain	3 months
Patients´ satisfaction with treatment	3 months
Bone turnover parameters	3 months