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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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This is prospective randomized, double blind study designed to evaluate the use of zoledronic acid in the prevention prevention of bone loss post allogenic BMT done for beta-thalassemia major patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients in this arm received zoledronic acid. |
|
| Control | Placebo Comparator | Patients in this arm received placebo as control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic acid 4 mg adjusted dose based on renal function IV 15-minute infusion every 3 months for a total of one year ( 4 doses ) beginning as soon as possible after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the percent change in the lumbar spine (L1 to L4) BMD, as measured by dual energy X-ray absorptiometry, at 12 months in patients with beta-thalassemia major undergoing allogenic BMT randomized to zoledronic acid versus placebo. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the percent change in total hip BMD at 12 months in the two study arms. | 1 year | |
| To compare the changes in bone turn over markers at 3, 6, and 12 months in the two treatment arms. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology-Oncology & SCT Research Center | Tehran | Tehran Province | 14114 | Iran |
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| ID | Term |
|---|---|
| D017086 | beta-Thalassemia |
| D013789 | Thalassemia |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | Placebo |
|
| To describe the incidence rate of all clinical fractures at 1 year in the two study arms. | 1 year |
| To describe the general safety of zoledronic acid. | 1 year |
| To describe the percent change in lumbar spine (L1 to L4) BMD and total hip BMD at 6 months when available. | 1 year |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |