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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
| Genentech, Inc. | INDUSTRY |
| Novartis | INDUSTRY |
| AstraZeneca |
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When treating very short children in puberty we are time-limited, as sex hormones cause the growth plates to fuse and growth to end. Growth Hormone (GH), plus drugs that stop puberty, increase height potential, but leave children sexually infantile at a critical time in development. Human and animal data show that estrogen, in females and males, is a principal regulator of the fusion of the growth plate in puberty. Using aromatase inhibitors (AIs), which block testosterone to estrogen conversion, in boys with different growth disorders, we have shown that AIs may have beneficial effects enhancing height potential in growth-retarded males, without affecting their puberty. However, no direct comparison of the effect of AIs alone vs. conventional GH treatment has been done to date. This study will assess the effect of AIs alone, GH alone and combination treatment in enhancing height potential in adolescent boys with idiopathic short stature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aromatase Inhibitor | Active Comparator | Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years |
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| Growth Hormone | Active Comparator | Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years |
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| Aromatase Inhibitor and Growth Hormone | Active Comparator | Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromatase Inhibitor | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Height | Differences in height gains | 0 to 24 months |
| Change in Predicted Height | Primary efficacy end point: change in predicted height (cm) from baseline at 24 months based on change in bone age (years) | 0 to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bone Density z Score Adjusted for Height | 0 to 24 months | |
| Change in Lean Body Mass | 0 to 24 months | |
| Change in Body Mass Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nelly Mauras, MD | Nemours Children's Clinic Jacksonville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States | ||
| Nemours Children's Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27710241 | Result | Mauras N, Ross JL, Gagliardi P, Yu YM, Hossain J, Permuy J, Damaso L, Merinbaum D, Singh RJ, Gaete X, Mericq V. Randomized Trial of Aromatase Inhibitors, Growth Hormone, or Combination in Pubertal Boys with Idiopathic, Short Stature. J Clin Endocrinol Metab. 2016 Dec;101(12):4984-4993. doi: 10.1210/jc.2016-2891. Epub 2016 Oct 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aromatase Inhibitor | Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years Aromatase Inhibitor |
| FG001 | Growth Hormone | Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years Growth Hormone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Pfizer | INDUSTRY |
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| Growth Hormone | Drug |
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| Aromatase Inhibitor and Growth Hormone | Drug |
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| 0 to 24 months |
| Change in IGF-I Concentrations | 0 to 24 months |
| Change in Testosterone | 0 to 24 months |
| Change in Estradiol | Those taking AI alone or AI/GH combined were grouped by type, either anastrozole or letrozole. | 0 to 24 months |
| Change in Estrone | 0 to 24 months |
| Orlando |
| Florida |
| 32801 |
| United States |
| Nemours Children's Clinic- Jefferson | Philadelphia | Pennsylvania | 19107 | United States |
| Veronica Mericq, MD | Santiago | Chile |
| FG002 | Aromatase Inhibitor and Growth Hormone | Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years Aromatase Inhibitor Growth Hormone Aromatase Inhibitor and Growth Hormone |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aromatase Inhibitor | Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years Aromatase Inhibitor |
| BG001 | Growth Hormone | Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years Growth Hormone |
| BG002 | Aromatase Inhibitor and Growth Hormone | Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years Aromatase Inhibitor Growth Hormone Aromatase Inhibitor and Growth Hormone |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Height | Differences in height gains | Differences in height gains from 0 to 24 months; Of the 76 Subjects, 65 completed all procedures at 24 months. | Posted | Mean | Standard Error | Centimeters | 0 to 24 months |
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| Primary | Change in Predicted Height | Primary efficacy end point: change in predicted height (cm) from baseline at 24 months based on change in bone age (years) | Of the 76 Subjects, 65 completed all procedures at 24 months. | Posted | Least Squares Mean | Standard Error | centimeters | 0 to 24 months |
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| Secondary | Change in Bone Density z Score Adjusted for Height | Of the 76 Subjects, 65 completed all procedures at 24 months, however, 2 Subjects had a screw/pin in their leg/hip at the 24 month visit, and therefore, could not have a DEXA scan performed (N=63). | Posted | Least Squares Mean | Standard Error | z-score | 0 to 24 months |
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| Secondary | Change in Lean Body Mass | Of the 76 Subjects, 65 completed all procedures at 24 months, however, 2 Subjects had a screw/pin in their leg/hip at the 24 month visit, and therefore, could not have a DEXA scan performed (N=63). | Posted | Mean | Standard Error | kg | 0 to 24 months |
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| Secondary | Change in Body Mass Index | Of the 76 Subjects, 65 completed all procedures at 24 months. | Posted | Mean | Standard Error | kg/m^2 | 0 to 24 months |
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| Secondary | Change in IGF-I Concentrations | Of the 76 Subjects, 65 completed all procedures at 24 months, however, 1 Subject, did not have IGF-1 results available for the 24 month visit (N=64). | Posted | Mean | Standard Error | ng/mL | 0 to 24 months |
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| Secondary | Change in Testosterone | Of the 76 Subjects, 65 completed all procedures at 24 months. | Posted | Mean | Standard Error | ng/dL | 0 to 24 months |
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| Secondary | Change in Estradiol | Those taking AI alone or AI/GH combined were grouped by type, either anastrozole or letrozole. | Of the 51 AI alone or AI/GH combined Subjects, 41 completed all procedures at 24 months, however, 1 Subject did not have Estrone results available for the 24 month visit (N=40). | Posted | Mean | Standard Error | pg/mL | 0 to 24 months |
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| Secondary | Change in Estrone | Of the 76 Subjects, 65 completed all procedures at 24 months, however, 1 Subject, did not have Estrone results available for the 24 month visit (N=64). | Posted | Mean | Standard Error | pg/mL | 0 to 24 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aromatase Inhibitor | Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years Aromatase Inhibitor | 0 | 25 | 4 | 25 | 0 | 25 |
| EG001 | Growth Hormone | Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years Growth Hormone | 0 | 25 | 2 | 25 | 0 | 25 |
| EG002 | Aromatase Inhibitor and Growth Hormone | Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years Aromatase Inhibitor Growth Hormone Aromatase Inhibitor and Growth Hormone | 0 | 26 | 2 | 26 | 0 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Slipped capital femoral epiphysis (SCFE) | Musculoskeletal and connective tissue disorders |
| |||
| Headache | Nervous system disorders |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders |
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| Self Injury | Psychiatric disorders |
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| Concussion | Nervous system disorders |
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| Testicular Torsion | Renal and urinary disorders |
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| Tibial Fracture and Torn Meniscus | Musculoskeletal and connective tissue disorders |
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| Back Injury | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nelly Mauras | Nemours Children's Clinic | 904-697-3674 | nmauras@nemours.org |
| ID | Term |
|---|---|
| D047072 | Aromatase Inhibitors |
| D000077384 | Anastrozole |
| D000077289 | Letrozole |
| D013006 | Growth Hormone |
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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