Effect of Zoledronic Acid on Bone Metabolism in Patients With Bone Metastasis and Prostate or Breast Cancer

Phase 4

Completed

• Conditions: Breast Cancer; Bone Metastasis; Prostate Cancer
• Interventions: Drug: Zoledronic Acid

• Registration Number: NCT00334139
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

Bisphosphonates have been used extensively in the treatment and the prevention of skeletal complications associated with bone metastases in patients with breast cancer and prostate cancer.

The purpose of this study is to assess the effect of zoledronic acid patients with prostate cancer or breast cancer and bone metastasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-06-05
• Study First Posted: 2006-06-06
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 411

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
zoledronic acid	Zoledronic Acid	-

Primary Outcome Measures

Name	Time	Method
Bone turnover assessed by bone turnover parameters	every 30 days

Secondary Outcome Measures

Name	Time	Method
Pain	every 30 days
Correlation between bone complications and bone turnover	end of study
Correlation between pain and bone turnover	at end of study
Quality of Life	every 30 days
Change in prostate specific antigen	every 30 days

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Ulm, Germany