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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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14 November 2016 |
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Main ID: |
NCT02564107 |
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Date of registration:
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28/09/2015 |
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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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A Study of Ibandronate (Bondronat) in Participants With Metastatic Bone Disease
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Scientific title:
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An Open Label Study of the Efficacy, Safety, and Pharmacoeconomics of Oral Ibandronate (Bondronat 50 mg) in Treatment of Metastatic Bone Disease |
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Date of first enrolment:
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November 2004 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02564107 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Bulgaria
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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:
- Females at least 18 years of age
- Breast cancer
- Bone metastases
Exclusion Criteria:
- Use of bisphosphonates within the last 3 months
- Prior use of gallium nitrate or metastron
- Severely impaired renal function
- Hypocalcemia or primary hyperparathyroidism
- Central nervous system (CNS) metastases
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pain; Bone Neoplasms; Neoplasm Metastasis
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Intervention(s)
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Drug: Ibandronate
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Primary Outcome(s)
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Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR)
[Time Frame: Up to 25 weeks]
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Secondary Outcome(s)
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Analgesic consumption according to participant questionnaire
[Time Frame: Up to 25 weeks]
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Incidence of adverse events (AEs)
[Time Frame: Up to approximately 7 months]
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Incidence of bone pain according to participant questionnaire
[Time Frame: Up to 25 weeks]
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Change in serum pyridinoline cross-linked carboxyterminal telopeptide of collagen type I (ICTP)
[Time Frame: Up to 25 weeks]
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Short Form 36 (SF-36) score
[Time Frame: Up to 25 weeks]
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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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