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This study will evaluate renal function in participants with metastatic bone disease due to breast cancer receiving intravenous (IV) infusions of ibandronate (Bondronat) 6 milligrams (mg), over either 15 minutes or 60 minutes, every 3 weeks. Efficacy and safety of ibandronate in the 2 groups of participants will also be compared. The anticipated time on study treatment is 7 months, and the target sample size is 318 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibandronate 15-Minute Infusion | Experimental | Participants will receive ibandronate IV infusions over a 15-minute interval. |
|
| Ibandronate 60-Minute Infusion | Active Comparator | Participants will receive ibandronate IV infusions over a 60-minute interval. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibandronate | Drug | Participants will receive ibandronate, 6 mg via IV infusion, every 3 weeks for up to 9 cycles. The infusion interval will be either 15 or 60 minutes depending upon treatment group assignment every 3 weeks (9 treatment cycles in total). |
| Measure | Description | Time Frame |
|---|---|---|
| Creatinine clearance (CrCl) Estimated by Cockcroft-Gault Formula | 28 days after last infusion (approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Bone Pain According to Visual Analog Scale (VAS) | Every 3 weeks up to approximately 6 months | |
| Number of Participants With of Skeletal Events (Vertebral and Non-Vertebral Fractures, Impending Fracture, Radiotherapy or Surgery to Bone) |
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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 |
|---|---|---|---|---|---|---|
| Amboise | 37403 | France | ||||
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|
| Up to approximately 7 months |
| Percentage of Participants on Analgesics According to World Health Organization (WHO) Three-Step Analgesic Ladder | Up to approximately 7 months |
| Karnofsky Index score | Every 3 weeks up to approximately 6 months |
| Angers |
| 49933 |
| France |
| Bayonne | 64100 | France |
| Besançon | 25030 | France |
| Boulogne-Billancourt | 92100 | France |
| Brest | 29609 | France |
| Chambéry | 73011 | France |
| Clermont-Ferrand | 63011 | France |
| Évreux | 27000 | France |
| Gap | 05007 | France |
| Hyères | 83400 | France |
| Le Chesnay | 78157 | France |
| Metz-Tessy | 74370 | France |
| Nantes | 44202 | France |
| Neuilly-sur-Seine | 92200 | France |
| Paris | 75475 | France |
| Paris | 75674 | France |
| Paris | 75970 | France |
| Rennes | 35042 | France |
| Rouen | 76000 | France |
| Saint-Brieuc | 22015 | France |
| Saint-Cloud | 92210 | France |
| Saint-Grégoire | 35768 | France |
| Saint-Jean | 31240 | France |
| Salouël | 80480 | France |
| Strasbourg | 67010 | France |
| Trappes | 78190 | France |
| Valenciennes | 59322 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Villejuif | 94804 | France |
| 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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