Clinical trial · Interventional
A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer
Open-Label Study to Establish the Short Term Efficacy of Intravenous Loading-Doses of Bondronat 6 mg in Patients With Breast Cancer and Skeletal Metastases Experiencing Moderate to Severe Pain, Within 7 Days After Initiation of Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain; Bone Neoplasms; Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibandronate | Drug | Ibandronic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ibandronate
- description
- Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.
- interventionNames
- Drug: Ibandronate
Primary outcomes (2)
- measure
- Percentage of participants with >=25% reduction in mean pain
- timeFrame
- up to Day 6
- measure
- Percentage of participants with =<35% increase in mean analgesic consumption
- timeFrame
- up to Days 7
Secondary outcomes (4)
- measure
- Change from Baseline in average pain score
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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. 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
References
Publications (0)
Data not yet available