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| ID | Type | Description | Link |
|---|---|---|---|
| M2372s | |||
| 23381 |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
| EMD Serono | INDUSTRY |
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The purpose of this study is to see if Arimidex, an aromatase inhibitor, can delay epiphyseal fusion and increase predicted adult height in boys who are growth hormone deficient, in puberty, and who are taking growth hormone. This is a double blind, placebo controlled 3 year trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arimidex and Growth Hormone | Active Comparator |
| |
| Placebo and Growth Hormone | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arimidex (Anastrozole) | Drug | Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement. | 12months, 24months, 36months |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objective is to determine the effect of Arimidex® treatment in bone mineralization in pubertal GH deficient males treated concurrently with growth hormone. | 12months, 24months, 36months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nelly Mauras, MD | Nemours Children's Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
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| ID | Term |
|---|---|
| D007018 | Hypopituitarism |
| D004393 | Dwarfism, Pituitary |
| D004392 | Dwarfism |
| ID | Term |
|---|---|
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Placebo | Drug | Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH. |
|
| Growth Hormone | Drug | GH (Nutropin®, Genentech, So. San Francisco, CA) will be administered throughout the trial at a dose of ~0.3mg/kg.w (no more than 0.4mg/kg.w) given subcutaneously (SC) at bedtime daily. Dose adjustments on the GH dose will be made by the investigator at least every 6mo. |
|
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |