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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004719-73 | EudraCT Number |
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The primary objective of this study is to investigate the repeat-dose pharmacokinetic (PK) profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in patients treated with 9-20 infusions of zoledronic acid during the previous 10-15 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zometa q 4 weeks | Experimental |
| |
| Zometa q 12 weeks | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17 | every four (4) weeks | |
| Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13 | every four (4) weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers at all visits. | every four (4) weeks | |
| Efficacy outcomes will be measured throughout the study by number and time to skeletal related events (determined by bone surveys and bone scans) as well as the measurement of pain and analgesic scores. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartis | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncotherapeutics | West Hollywood | California | 90069 | United States | ||
| Rocky Mountain Cancer Centers RMCC |
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| Label | URL |
|---|---|
| Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers. | View source |
| Results for CZOL446E2105 can be found on the Novartis Clinical Trial Results Website | View source |
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| bone survey = every 12 weeks; bone scan = every 24 weeks; pain & analgesic scores = weekly prior to visit 8 (inclusive), every 4 weeks after visit 8 |
| Greenwood Village |
| Colorado |
| United States |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | United States |
| Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Huntsman Cancer Institute Univ. of Utah | Salt Lake City | Utah | 84112-0550 | United States |
| University of Vermont Fletcher Allen Health Care | Burlington | Vermont | 05404 | United States |
| Virginia Cancer Institute Virginia Cancer Center | Richmond | Virginia | 23230 | United States |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| 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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