Clinical trial · Interventional
A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease
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
- 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 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.
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 (2)
- type
- EXPERIMENTAL
- label
- Ibandronate IV Infusion
- description
- Participants will receive ibandronate, 6 mg via IV infusion, every 3 to 4 weeks for 4 months.
- interventionNames
- Drug: Ibandronate
- type
- EXPERIMENTAL
- label
- Ibandronate PO Tablet
- description
- Participants will receive ibandronate, 50 mg PO daily, for 4 months.
- interventionNames
- Drug: Ibandronate
Primary outcomes (2)
- measure
- Response rate according to reduction in BPI most acute pain score from Baseline
- timeFrame
- Month 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available