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

Primary Purpose

Bone Neoplasms

Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bone Neoplasms focused on measuring Prostate Cancer, Breast Cancer, Multiple Myeloma, Zoledronic acid, Bone metastases, Skeletal Related Events (SREs), Renal Impairment, Osteonecrosis of the Jaw (ONJ), Bone involvement, Multiple Myeloma (MM)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Documented bone metastases from breast cancer, prostate cancer or multiple myeloma
  • Prior treatment with zoledronic acid for 1-2 yrs
  • Life expectancy of at least 6 months

Exclusion criteria:

  • Prior treatment with bisphosphonates other than zoledronic acid
  • Abnormal kidney function
  • Current or previous dental problems or planned dental surgery
  • Pregnant or likely to become pregnant during the study

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zoledronic Acid

Arm Description

ZOL446

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
February 9, 2007
Last Updated
February 23, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00434447
Brief Title
Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases
Official Title
A Phase IV Study of Zoledronic Acid Therapy in Patients With Bone Metastases From Breast Cancer or Hormone Resistant Prostate Cancer, or Bone Involvement From Multiple Myeloma, Assessing Long-term Efficacy and Safety
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Neoplasms
Keywords
Prostate Cancer, Breast Cancer, Multiple Myeloma, Zoledronic acid, Bone metastases, Skeletal Related Events (SREs), Renal Impairment, Osteonecrosis of the Jaw (ONJ), Bone involvement, Multiple Myeloma (MM)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zoledronic Acid
Arm Type
Experimental
Arm Description
ZOL446
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
ZOL446
Primary Outcome Measure Information:
Title
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).
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Documented bone metastases from breast cancer, prostate cancer or multiple myeloma Prior treatment with zoledronic acid for 1-2 yrs Life expectancy of at least 6 months Exclusion criteria: Prior treatment with bisphosphonates other than zoledronic acid Abnormal kidney function Current or previous dental problems or planned dental surgery Pregnant or likely to become pregnant during the study Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmeceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Canberra
State/Province
Australian Capital Territory
Country
Australia
Facility Name
Novartis Investigative Site
City
Concord
State/Province
New South Wales
Country
Australia
Facility Name
Novartis Investigative Site
City
Liverpool
State/Province
New South Wales
Country
Australia
Facility Name
Novartis Investigative Site
City
Wagga Wagga
State/Province
New South Wales
Country
Australia
Facility Name
Novartis Investigative Site
City
Redcliffe
State/Province
Queensland
Country
Australia
Facility Name
Novartis Investigative Site
City
Townsville
State/Province
Queensland
Country
Australia
Facility Name
Novartis Investigative Site
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Novartis Investigative Site
City
Ballarat
State/Province
Victoria
Country
Australia
Facility Name
Novartis Investigative Site
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
Novartis Investigative Site
City
Frankston
State/Province
Victoria
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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