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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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7 November 2016 |
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Main ID: |
NCT02553850 |
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Date of registration:
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08/09/2015 |
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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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An Observational Study in Patients With Breast Cancer and Bone Metastases Receiving Ibandronate (Bondronat)
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Scientific title:
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A SURVEY TO STUDY THE CORRELATION BETWEEN THE SERUM LEVELS OF BONE TURNOVER MARKERS AND THE CLINICAL PICTURE IN PATIENTS WITH BREAST CANCER AND BONE METASTASES RECEIVING IBRADONIC ACID TREATMENT |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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442 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02553850 |
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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:
- All criteria in accordance with the Summary of Product Characteristics of Bondronat
(ibandronate)
- Adult patients greater than (>) 18 years of age
- Histologically confirmed breast cancer
- Confirmed bone metastasis (by bone scintigraphy, X-ray, computed tomography or
magnetic resonance imaging)
- Life expectancy >6 months
- No previous bisphosphonate therapy
- Patients signed written informed consent form before study start
Exclusion Criteria:
- All criteria in accordance with the Summary of Product Characteristics of
Bondronat(ibandronate)
- Hypersensitivity to the active substance or any of the excipients of Bondronat
(ibandronate)
- Hypersensitivity to bisphosphonates
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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Breast Cancer
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Primary Outcome(s)
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Treatment response rate
[Time Frame: 12 months]
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Beta C-terminal telopeptide (B-CTx) level
[Time Frame: 12 months]
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Secondary Outcome(s)
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Number of patients who died due to progression of breast cancer
[Time Frame: 12 months]
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Safety: Incidence of adverse events
[Time Frame: 12 months]
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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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