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This study will evaluate the efficacy, safety, and effect on quality of life of oral ibandronate (Bondronat) in participants with breast cancer and metastatic bone disease. The anticipated time on study treatment is 25 weeks, and the target sample size is 50 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibandronate | Experimental | Female participants with metastatic bone disease secondary to breast cancer will receive ibandronate for a period of 25 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibandronate | Drug | Participants will receive ibandronate, 50 milligrams (mg) by mouth every morning, for a period of 25 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR) | Up to 25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bone pain according to participant questionnaire | Up to 25 weeks | |
| Analgesic consumption according to participant questionnaire | Up to 25 weeks | |
| Change in serum pyridinoline cross-linked carboxyterminal telopeptide of collagen type I (ICTP) |
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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 |
|---|---|---|---|---|---|---|
| Plovdiv | 4004 | 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 25 weeks |
| Short Form 36 (SF-36) score | Up to 25 weeks |
| Incidence of adverse events (AEs) | Up to approximately 7 months |
| Shumen |
| Bulgaria |
| Sofia | 1527 | Bulgaria |
| Sofia | 1756 | Bulgaria |
| Sofia | 1784 | Bulgaria |
| Stara Zagora | 8000 | Bulgaria |
| Varna | 9010 | Bulgaria |
| Veliko Tarnovo | 5000 | Bulgaria |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |