- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02561039
A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease
November 1, 2016 updated by: Hoffmann-La Roche
Randomized, Open Label Study to Assess the Efficacy and Safety of the Intravenous and Oral Ibandronic Acid for Improving the Performance Status of Patients With Malignant Bone Disease Secondary to Solid Tumors and Hematological Malignancies
This study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate to severe pain.
Participants will be randomized to receive ibandronate either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily.
Pain response and Karnofsky Performance Index (KPI) will be measured at intervals throughout the study.
The anticipated time on study treatment is 4 months and the target sample size is 150 individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bourgas, Bulgaria, 8000
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Haskovo, Bulgaria, 6300
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4004
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Sofia, Bulgaria, 1757
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Sofia, Bulgaria, 1784
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Varna, Bulgaria, 9002
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Varna, Bulgaria, 9010
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Vratza, Bulgaria, 3000
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults at least 18 years of age
- Malignant bone disease due to multiple myeloma or cancer of the lung, prostate, gastrointestinal (GI) tract, ovary, or bladder
- Bone pain defined as a Brief Pain Inventory (BPI) most acute pain score greater than or equal to 4
- Radiologically confirmed bone disease disease
Exclusion Criteria:
- Previous treatment with ibandronate (Bondronat) within previous 2 months
- Severely impaired renal function
- Known brain metastases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ibandronate IV Infusion
Participants will receive ibandronate, 6 mg via IV infusion, every 3 to 4 weeks for 4 months.
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Participants will receive ibandronate, either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily, for 4 months.
Other Names:
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Experimental: Ibandronate PO Tablet
Participants will receive ibandronate, 50 mg PO daily, for 4 months.
|
Participants will receive ibandronate, either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily, for 4 months.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate according to reduction in BPI most acute pain score from Baseline
Time Frame: Month 4
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Month 4
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Change in KPI
Time Frame: Baseline to Month 4
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Baseline to Month 4
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to onset of decrease in most acute pain score
Time Frame: Up to 4 months
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Up to 4 months
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Analgesic consumption according to participant diary
Time Frame: Up to 5 months
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Up to 5 months
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Incidence of adverse events
Time Frame: Up to 5 months
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Up to 5 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
September 24, 2015
First Submitted That Met QC Criteria
September 24, 2015
First Posted (Estimate)
September 25, 2015
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML20713
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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