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This 2 arm study will compare the efficacy of intravenous Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 and then every 3-4 weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibandronate [Bondronat] | Drug | 6mg iv on days 1-3, and every 3-4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain, as measured by Brief Pain Inventory and analgesic use | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Performance score and QoL measures | Week 24 | |
| AEs and laboratory parameters | Throughout study | |
| Opioid side effects |
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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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35205 | United States | |||
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| zoledronic acid |
| Drug |
4mg iv on day 1 and every 3-4 weeks |
|
| Throughout study |
| Skeletal-related events | Throughout study |
| Sedona |
| Arizona |
| 86336 |
| United States |
| Ocoee | Florida | 34761 | United States |
| Macon | Georgia | 31201 | United States |
| Galesburg | Illinois | 61401 | United States |
| Indianapolis | Indiana | 46227 | United States |
| Kansas City | Missouri | 64131 | United States |
| Henderson | Nevada | 89052 | United States |
| Reno | Nevada | 89502 | United States |
| Albany | New York | 12208 | United States |
| Oklahoma City | Oklahoma | 73120 | United States |
| Eugene | Oregon | 97401-8122 | United States |
| Nashville | Tennessee | 37209 | United States |
| Abilene | Texas | 79606-5208 | United States |
| Arlington | Texas | 76014 | United States |
| Beaumont | Texas | 77702-1449 | United States |
| Dallas | Texas | 75230 | United States |
| Dallas | Texas | 75231 | United States |
| Fort Worth | Texas | 76177 | United States |
| Fredericksburg | Texas | 78624 | United States |
| Longview | Texas | 75601 | United States |
| Round Rock | Texas | 78681 | United States |
| Norfolk | Virginia | 23502 | United States |
| Seattle | Washington | 98104 | United States |
| Spokane | Washington | 99218 | United States |
| Vancouver | Washington | 98684 | United States |
| Buenos Aires | C1280AEB | Argentina |
| Buenos Aires | C1406FWY | Argentina |
| Buenos Aires | C1408INH | Argentina |
| La Plata | 1900 | Argentina |
| Lanus | B1824DLR | Argentina |
| Mendoza | 5500 | Argentina |
| St Leonards | 2065 | Australia |
| Waratah | 2298 | Australia |
| Brussels | 1000 | Belgium |
| Turnhout | 2300 | Belgium |
| Wilrijk | 2610 | Belgium |
| Greenfield Park | Quebec | J4V 2H1 | Canada |
| Santiago | Chile |
| Lyon | 69373 | France |
| Nice | 06189 | France |
| Paris | 75248 | France |
| Dessau | 06846 | Germany |
| Duisburg | 47166 | Germany |
| Heidelberg | 69120 | Germany |
| Trier | 54290 | Germany |
| Guatemala City | 01010 | Guatemala |
| Guatemala City | 01015 | Guatemala |
| Guatemala City | Guatemala |
| Budapest | 1125 | Hungary |
| Győr | 9002 | Hungary |
| Naples | 80131 | Italy |
| Chihuahua City | 31000 | Mexico |
| Mexico City | 03100 | Mexico |
| Mérida | 97500 | Mexico |
| Panama City | Panama |
| Lodz | 93-510 | Poland |
| Olsztyn | 10-228 | Poland |
| Otwock | 05-400 | Poland |
| Ponce | 00733-1324 | Puerto Rico |
| San Juan | 00921-3201 | Puerto Rico |
| Kazan' | 420029 | Russia |
| Moscow | 115478 | Russia |
| Moscow | 117837 | Russia |
| Moscow | 125284 | Russia |
| Moscow | Russia |
| Obninsk | 249020 | Russia |
| Saint Petersburg | 197022 | Russia |
| Saint Petersburg | 197758 | Russia |
| Baden | 5404 | Switzerland |
| Exeter | EX2 5DW | United Kingdom |
| Wolverhampton | WV10 0QP | United Kingdom |
| 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 |
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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