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The purpose of the study is to determine if there are differences in the final height or hormone profile of short pubertal boys placed on different forms of aromatase inhibitor now routinely used to increase stature: Anastrozole and Letrozole. It also should determine if there are differences in the side effect profiles of the two drugs to be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole | Active Comparator | Letrozole 2.5 mg daily |
|
| Anastrozole | Active Comparator | Anastrozole 1 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug |
| ||
| Anastrozole |
| Measure | Description | Time Frame |
|---|---|---|
| Predicted Adult Height at Year 3 | Heights will be obtained by physical exam every 6 months during treatment. Skeletal maturation will be assessed from an x-ray by the method of Greulich and Pyle at baseline and every 12 months until the end of treatment. Predicted adult height will be calculated at baseline and at the end of treatment based upon measured height and skeletal maturation (bone age). | Year 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Testosterone | Baseline, year 3 | |
| Dihydrotestosterone | Baseline, year 3 | |
| Androstenedione |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E Kirk Neely, MD | Stanford University | Principal Investigator |
| Laura K Bachrach, MD | Stanford University | Principal Investigator |
| Walter A Zegarra, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital | Palo Alto | California | 94301 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25137428 | Result | Neely EK, Kumar RB, Payne SL, Ranadive SA, Suchet DI. Letrozole vs anastrozole for height augmentation in short pubertal males: first year data. J Clin Endocrinol Metab. 2014 Nov;99(11):4086-93. doi: 10.1210/jc.2014-2432. Epub 2014 Aug 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Letrozole | Participants receive letrozole 2.5 mg daily |
| FG001 | Anastrozole | Participants receive anastrozole 1 mg daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who finished the first year of therapy are included in the analysis, excluding participants who had received growth hormone.
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| ID | Title | Description |
|---|---|---|
| BG000 | Letrozole | Participants receive letrozole 2.5 mg daily |
| BG001 | Anastrozole | Participants receive anastrozole 1 mg daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Predicted Adult Height at Year 3 | Heights will be obtained by physical exam every 6 months during treatment. Skeletal maturation will be assessed from an x-ray by the method of Greulich and Pyle at baseline and every 12 months until the end of treatment. Predicted adult height will be calculated at baseline and at the end of treatment based upon measured height and skeletal maturation (bone age). | Participants who finished the first year of therapy are included in the analysis, excluding participants who had received growth hormone. | Posted | Mean | Standard Deviation | cm | Year 3 |
|
3 years
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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 | Letrozole | Participants receive letrozole 2.5 mg daily | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sacroiliitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unexpected serious adverse event; significant but not persistent. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| E Kirk Neely | Stanford University | 650-723-5791 | neely@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 26, 2019 | Jun 24, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2021 | Jun 24, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004392 | Dwarfism |
| ID | Term |
|---|---|
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D000077384 | Anastrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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|
| Baseline, year 3 |
| Luteinizing Hormone | Baseline, year 3 |
| Follicle Stimulating Hormone | Baseline, year 3 |
| Insulin-like Growth Factor Type 1 | Baseline, year 3 |
| Inhibin B | Baseline, year 3 |
| Estradiol | Baseline, year 3 |
| Estrone | Baseline, year 3 |
| Number of Adverse Events Related to Acne or Bone Fracture | 3 years |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Bone age | Mean | Standard Deviation | months |
|
| Predicted Adult Height | Mean | Standard Deviation | cm |
|
Participants receive anastrozole 1 mg daily
|
|
| Secondary | Serum Testosterone | Participants who finished the first year of therapy are included in the analysis, excluding participants who had received growth hormone. | Posted | Mean | Standard Deviation | ng/dL | Baseline, year 3 |
|
|
|
| Secondary | Dihydrotestosterone | Participants who finished the first year of therapy are included in the analysis, excluding participants who had received growth hormone. | Posted | Mean | Standard Deviation | ng/dL | Baseline, year 3 |
|
|
|
| Secondary | Androstenedione | Participants who finished the first year of therapy are included in the analysis, excluding participants who had received growth hormone. | Posted | Mean | Standard Deviation | ng/dL | Baseline, year 3 |
|
|
|
| Secondary | Luteinizing Hormone | Participants who finished the first year of therapy are included in the analysis, excluding participants who had received growth hormone. | Posted | Mean | Standard Deviation | mIU/mL | Baseline, year 3 |
|
|
|
| Secondary | Follicle Stimulating Hormone | Participants who finished the first year of therapy are included in the analysis, excluding participants who had received growth hormone. | Posted | Mean | Standard Deviation | mIU/mL | Baseline, year 3 |
|
|
|
| Secondary | Insulin-like Growth Factor Type 1 | Participants who finished the first year of therapy are included in the analysis, excluding participants who had received growth hormone. | Posted | Mean | Standard Deviation | ng/mL | Baseline, year 3 |
|
|
|
| Secondary | Inhibin B | Participants who finished the first year of therapy are included in the analysis, excluding participants who had received growth hormone. | Posted | Mean | Standard Deviation | pg/mL | Baseline, year 3 |
|
|
|
| Secondary | Estradiol | Participants who finished the first year of therapy are included in the analysis, excluding participants who had received growth hormone. | Posted | Mean | Standard Deviation | pg/mL | Baseline, year 3 |
|
|
|
| Secondary | Estrone | Participants who finished the first year of therapy are included in the analysis, excluding participants who had received growth hormone. | Posted | Mean | Standard Deviation | pg/mL | Baseline, year 3 |
|
|
|
| Secondary | Number of Adverse Events Related to Acne or Bone Fracture | Participants who finished the first year of therapy are included in the analysis, excluding participants who had received growth hormone. | Posted | Number | events | 3 years |
|
|
|
| 39 |
| 0 |
| 39 |
| 12 |
| 39 |
| EG001 | Anastrozole | Participants receive anastrozole 1 mg daily | 0 | 40 | 2 | 40 | 10 | 40 |
|
| Neuro event | Nervous system disorders | Systematic Assessment | Unexpected serious adverse event; significant but not persistent. |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Aggression | Nervous system disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hair loss | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |