Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases

Phase 4

Completed

• Conditions: Bone Neoplasms
• Interventions: Drug: Zoledronic acid

• Registration Number: NCT00434447
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study is designed to monitor the safety and efficacy of long-term treatment with zoledronic acid by assessing the incidence of, renal impairment, osteonecrosis of the jaw(ONJ), overall safety and skeletal related events (SREs) beyond 12 months treatment

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-02-09
• Study First Submitted QC: 2007-02-12
• Study First Posted: 2007-02-13
• Primary Completion: 2009-09
• Status Verified: 2010-10
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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	ZOL446

Primary Outcome Measures

Name	Time	Method
Safety assessed by incidence of renal impairment, osteonecrosis of the Jaw (ONJ), adverse events and serious adverse events. Efficacy assessed by incidence of skeletal related events (SREs).	52 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇦🇺 Frankston, Victoria, Australia