A Survey of Breast Cancer Patients With Metastatic Bone Disease Receiving Oral Ibandronate

August 18, 2015 updated by: Hoffmann-La Roche

A Multi-Center Observational Survey of Breast Cancer Patients With Metastatic Bone Disease Receiving Oral Ibandronate (BONDORAL)

This observational, multicenter survey is designed to assess the efficacy of oral ibandronate in adults with breast cancer and metastatic bone disease. Data on the use of ibandronate in clinical practice will be collected from Hungarian patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

582

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1125
      • Budapest, Hungary, 1083
      • Budapest, Hungary, 1145
      • Budapest, Hungary, 1106
      • Budapest, Hungary, 1067
      • Budapest, Hungary, 1031
      • Budapest, Hungary, 1441
      • Debrecen, Hungary, 4032
      • Debrecen, Hungary, H-4031
      • Gyor, Hungary, 9023
      • Gyula, Hungary, 5700
      • Kaposvar, Hungary, 7400
      • Kecskemet, Hungary, 6000
      • Kistarcsa, Hungary, 2143
      • Miskolc, Hungary, 3501
      • Nyíregyháza, Hungary, 4400
      • Pecs, Hungary, 7623
      • Szeged, Hungary, 6720
      • Szekesfehervar, Hungary, 8000
      • Szekszard, Hungary, 7100
      • Szolnok, Hungary, 5004
      • Szombathely, Hungary, 9700
      • Tatabánya, Hungary, 2800
      • Veszprem, Hungary, 8200
      • Zalaegerszeg, Hungary, 8900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Breast cancer patients with metastatic bone disease who are receiving oral ibandronate will be followed for approximately 1 year.

Description

Inclusion Criteria:

  • Adults at least 18 years of age
  • Histologically confirmed breast cancer with bone metastasis
  • Receiving or indicated for the tablet formulation of ibandronate according to the summary of product characteristics (SmPC) and local labeling

Exclusion Criteria:

  • Contraindication to ibandronate according to SmPC
  • Ongoing participation in any trial evaluating the efficacy and/or safety of ibandronate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study population
Breast cancer patients with metastatic bone disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in bone pain according to Visual Analog Scale (VAS) score
Time Frame: From Baseline to the end of 1 year
From Baseline to the end of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: Up to approximately 1 year
Up to approximately 1 year
Compliance with tablet formulation of ibandronate according to Case Report Form (CRF) questionnaire
Time Frame: Up to approximately 1 year
Up to approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

August 18, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22421

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe