Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the short term efficacy of ibandronate (6 mg intravenous [IV]) in participants with breast cancer and malignant bone disease, with moderate to severe pain. All participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain response will be measured on Days 1-7. The anticipated time on study treatment is 3 days, and the target sample size is 182 individuals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibandronate | Experimental | Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibandronate | Drug | Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with >=25% reduction in mean pain | up to Day 6 | |
| Percentage of participants with =<35% increase in mean analgesic consumption | up to Days 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in average pain score | Baseline (Days 0), 5, and 7 | |
| Analgesic consumption | up to Day 7 | |
| Pain response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Budapest | 1031 | Hungary | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to Day 7 |
| Time to pain response | up to Day 7 |
| Budapest |
| 1082 |
| Hungary |
| Budapest | 1106 | Hungary |
| Budapest | 1122 | Hungary |
| Budapest | 1135 | Hungary |
| Budapest | 1145 | Hungary |
| Győr | 9002 | Hungary |
| Gyula | 5700 | Hungary |
| Kecskemét | 6000 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Szeged | 6720 | Hungary |
| Székesfehérvár | 8000 | Hungary |
| Szombathely | 9700 | Hungary |
| Veszprém | 8200 | Hungary |
| Zalaegerszeg | 8900 | Hungary |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077557 | Ibandronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided