A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer
- Registration Number
- NCT02553707
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will assess the short term efficacy of ibandronate (6 mg intravenous \[IV\]) in participants with breast cancer and malignant bone disease, with moderate to severe pain. All participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain response will be measured on Days 1-7. The anticipated time on study treatment is 3 days, and the target sample size is 182 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 182
Inclusion Criteria
- Female participants greater than or equal to (>=) 18 years of age
- Breast cancer with bone metastases
- Pain score of >=4 on Worst Pain scale of Brief Pain Inventory (BPI)
- Stable analgesic regimen.
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Exclusion Criteria
- Participants who have received a bisphosphonate within 3 weeks of start of trial
- Radiotherapy to bone within 4 weeks of enrolment
- Hypersensitivity to ibandronate
- Central nervous system (CNS) or meningeal metastases
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ibandronate Ibandronate Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.
- Primary Outcome Measures
Name Time Method Percentage of participants with =<35% increase in mean analgesic consumption up to Days 7 Percentage of participants with >=25% reduction in mean pain up to Day 6
- Secondary Outcome Measures
Name Time Method Change from Baseline in average pain score Baseline (Days 0), 5, and 7 Pain response up to Day 7 Analgesic consumption up to Day 7 Time to pain response up to Day 7