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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02528747

Enrollment

582

Registered

2015-08-19

Start date

2009-01-31

Completion date

2011-12-31

Last updated

2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Hungary

Outcome results