Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole
- Registration Number
- NCT02137538
- Lead Sponsor
- Stanford University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 79
- 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
- Bone age reading more than 14.0 years
- Follicle stimulating hormone > 20 IU/L
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Letrozole Letrozole Letrozole 2.5 mg daily Anastrozole Anastrozole Anastrozole 1 mg daily
- Primary Outcome Measures
Name Time Method Predicted Adult Height at Year 3 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).
- Secondary Outcome Measures
Name Time Method Inhibin B Baseline, year 3 Follicle Stimulating Hormone Baseline, year 3 Serum Testosterone Baseline, year 3 Androstenedione Baseline, year 3 Dihydrotestosterone Baseline, year 3 Luteinizing Hormone Baseline, year 3 Estradiol Baseline, year 3 Number of Adverse Events Related to Acne or Bone Fracture 3 years Insulin-like Growth Factor Type 1 Baseline, year 3 Estrone Baseline, year 3
Trial Locations
- Locations (1)
Lucile Packard Children's Hospital
🇺🇸Palo Alto, California, United States