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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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31 August 2015 |
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Main ID: |
NCT02528747 |
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Date of registration:
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06/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Survey of Breast Cancer Patients With Metastatic Bone Disease Receiving Oral Ibandronate
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Scientific title:
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A Multi-Center Observational Survey of Breast Cancer Patients With Metastatic Bone Disease Receiving Oral Ibandronate (BONDORAL) |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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582 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02528747 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Hungary
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Metastatic Breast Cancer
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Primary Outcome(s)
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Change in bone pain according to Visual Analog Scale (VAS) score
[Time Frame: From Baseline to the end of 1 year]
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Secondary Outcome(s)
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Compliance with tablet formulation of ibandronate according to Case Report Form (CRF) questionnaire
[Time Frame: Up to approximately 1 year]
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Incidence of adverse events
[Time Frame: Up to approximately 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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