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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibandronate IV Infusion | Experimental | Participants will receive ibandronate, 6 mg via IV infusion, every 3 to 4 weeks for 4 months. |
|
| Ibandronate PO Tablet | Experimental | Participants will receive ibandronate, 50 mg PO daily, for 4 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibandronate | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate according to reduction in BPI most acute pain score from Baseline | Month 4 | |
| Change in KPI | Baseline to Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of decrease in most acute pain score | Up to 4 months | |
| Analgesic consumption according to participant diary | Up to 5 months | |
| Incidence of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burgas | 8000 | Bulgaria | ||||
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001859 | Bone Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077557 | Ibandronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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|
| Up to 5 months |
| Haskovo |
| 6300 |
| Bulgaria |
| Pleven | 5800 | Bulgaria |
| Plovdiv | 4004 | Bulgaria |
| Sofia | 1757 | Bulgaria |
| Sofia | 1784 | Bulgaria |
| Varna | 9002 | Bulgaria |
| Varna | 9010 | Bulgaria |
| Vratsa | 3000 | Bulgaria |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |