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This single arm study will assess the efficacy of loading doses of intravenous Bondronat in reducing pain in patients with breast cancer and metastatic bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibandronate [Bondronat] | Drug | 6mg iv on days 1-3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption | Days 5 - 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean worst pain score over first 7 days | Day 7 | |
| Analgesic consumption | Day 7 | |
| Karnofsky index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandroupoli | Greece | |||||
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| Day 7 |
| AEs, laboratory parameters | Throughout study |
| Athens |
| Greece |
| Haidari | Greece |
| Pátrai | Greece |
| Piraeus | Greece |
| Thessaloniki | Greece |
| 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 |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
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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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