Phase 4
N=79
Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole
Short Stature
Bottom Line
View on ClinicalTrials.gov: NCT02137538 ↗Enrolled (actual)
79
Serious AEs
2.5%
Results posted
Jul 2021
Primary outcome: Primary: Predicted Adult Height at Year 3 — 167.8; 169.4 cm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Letrozole (Drug); Anastrozole (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- Male
- Sponsor
- Stanford University
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Predicted Adult Height at Year 3 |
167.8; 169.4 | — |
| SECONDARY Serum Testosterone |
213.1; 162.1; 882.3; 680.1 | — |
| SECONDARY Dihydrotestosterone |
22.5; 19.1; 65.0; 44.1 | — |
| SECONDARY Androstenedione |
35.3; 37.4; 79.9; 77.9 | — |
| SECONDARY Luteinizing Hormone |
2.3; 1.8; 4.7; 3.4 | — |
| SECONDARY Follicle Stimulating Hormone |
3.3; 2.5; 6.6; 4.5 | — |
| SECONDARY Insulin-like Growth Factor Type 1 |
306.2; 306.9; 226.1; 298.7 | — |
| SECONDARY Inhibin B |
203.4; 217.0; 257.6; 262.1 | — |
| SECONDARY Estradiol |
4.9; 4.7; 2.7; 6.2 | — |
| SECONDARY Estrone |
8.7; 8.0; 2.7; 3.5 | — |
| SECONDARY Number of Adverse Events Related to Acne or Bone Fracture |
3; 3; 3; 5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Current height less than 5th percentile AND/OR
- Predicted adult height (based on bone age) more than 10 cm below target height (mid parental height)
- Evidence of puberty: physical signs and serum luteinizing hormone > 0.3 IU/L and testosterone > 15 ng/dl
Exclusion Criteria
- Bone age reading more than 14.0 years
- Follicle stimulating hormone > 20 IU/L
Data sourced from ClinicalTrials.gov (NCT02137538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.