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NCT02528747 Clinical Trial

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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02528747
Other study ID # ML22421
Secondary ID
Status Completed
Phase N/A
First received August 6, 2015
Last updated August 18, 2015
Start date January 2009
Est. completion date December 2011

Study information
Verified date August 2015
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Hungary: N/A
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 582
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in bone pain according to Visual Analog Scale (VAS) score From Baseline to the end of 1 year No
Secondary Compliance with tablet formulation of ibandronate according to Case Report Form (CRF) questionnaire Up to approximately 1 year No
Secondary Incidence of adverse events Up to approximately 1 year No
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