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This single arm study will assess the efficacy and safety of loading doses of intravenous Bondronat in patients with breast cancer and malignant 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 and analgesic consumption | Days 1, 7 and 14 |
| Measure | Description | Time Frame |
|---|---|---|
| AEs and laboratory parameters | Days 1, 4 and 7 | |
| Serum creatinine | Days 1, 4 and 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 |
|---|---|---|---|---|---|---|
| Ankara | 06018 | Turkey (Türkiye) | ||||
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| Day 7 |
| Ankara |
| 06230 |
| Turkey (Türkiye) |
| Istanbul | 34300 | Turkey (Türkiye) |
| Istanbul | 34390 | Turkey (Türkiye) |
| Izmir | 35100 | Turkey (Türkiye) |
| Shhiye, Ankara | 06100 | Turkey (Türkiye) |
| 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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