Back to resultsA Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease
Primary Purpose
Pain; Bone Neoplasms; Neoplasm Metastasis
Status
Completed
Phase
Phase 3
Locations
Bulgaria
Study Type
Interventional
Intervention
Ibandronate
Sponsored by
About this trial
This is an interventional treatment trial for Pain; Bone Neoplasms; Neoplasm Metastasis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ibandronate IV Infusion
Ibandronate PO Tablet
Arm Description
Participants will receive ibandronate, 6 mg via IV infusion, every 3 to 4 weeks for 4 months.
Participants will receive ibandronate, 50 mg PO daily, for 4 months.
Outcomes
Primary Outcome Measures
Response rate according to reduction in BPI most acute pain score from Baseline
Change in KPI
Secondary Outcome Measures
Time to onset of decrease in most acute pain score
Analgesic consumption according to participant diary
Incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02561039
Brief Title
A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain; Bone Neoplasms; Neoplasm Metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibandronate IV Infusion
Arm Type
Experimental
Arm Description
Participants will receive ibandronate, 6 mg via IV infusion, every 3 to 4 weeks for 4 months.
Arm Title
Ibandronate PO Tablet
Arm Type
Experimental
Arm Description
Participants will receive ibandronate, 50 mg PO daily, for 4 months.
Intervention Type
Drug
Intervention Name(s)
Ibandronate
Other Intervention Name(s)
Bondronat
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response rate according to reduction in BPI most acute pain score from Baseline
Time Frame
Month 4
Title
Change in KPI
Time Frame
Baseline to Month 4
Secondary Outcome Measure Information:
Title
Time to onset of decrease in most acute pain score
Time Frame
Up to 4 months
Title
Analgesic consumption according to participant diary
Time Frame
Up to 5 months
Title
Incidence of adverse events
Time Frame
Up to 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Bourgas
ZIP/Postal Code
8000
Country
Bulgaria
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1757
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
City
Varna
ZIP/Postal Code
9002
Country
Bulgaria
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
City
Vratza
ZIP/Postal Code
3000
Country
Bulgaria
12. IPD Sharing Statement
Learn more about this trial
A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease
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