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

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Budapest, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change in bone pain according to Visual Analog Scale (VAS) score

Time frame: From Baseline to the end of 1 year

Secondary outcomes

Compliance with tablet formulation of ibandronate according to Case Report Form (CRF) questionnaire

Time frame: Up to approximately 1 year
Incidence of adverse events

Time frame: Up to approximately 1 year

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Aug 19, 2015
Registry last updated: Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed