Back to resultsAromatase Inhibitor Growth Study: Letrozole vs. Anastrozole
Primary Purpose
Short Stature
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Letrozole
Anastrozole
Sponsored by
About this trial
This is an interventional treatment trial for Short Stature
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
Sites / Locations
- Lucile Packard Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Letrozole
Anastrozole
Arm Description
Letrozole 2.5 mg daily
Anastrozole 1 mg daily
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Serum Testosterone
Dihydrotestosterone
Androstenedione
Luteinizing Hormone
Follicle Stimulating Hormone
Insulin-like Growth Factor Type 1
Inhibin B
Estradiol
Estrone
Number of Adverse Events Related to Acne or Bone Fracture
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02137538
Brief Title
Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole
Official Title
Randomization to Letrozole vs. Anastrozole in Short Pubertal Males
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 18, 2009 (Actual)
Primary Completion Date
June 5, 2018 (Actual)
Study Completion Date
June 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Stature
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Letrozole
Arm Type
Active Comparator
Arm Description
Letrozole 2.5 mg daily
Arm Title
Anastrozole
Arm Type
Active Comparator
Arm Description
Anastrozole 1 mg daily
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Primary Outcome Measure Information:
Title
Predicted Adult Height at Year 3
Description
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).
Time Frame
Year 3
Secondary Outcome Measure Information:
Title
Serum Testosterone
Time Frame
Baseline, year 3
Title
Dihydrotestosterone
Time Frame
Baseline, year 3
Title
Androstenedione
Time Frame
Baseline, year 3
Title
Luteinizing Hormone
Time Frame
Baseline, year 3
Title
Follicle Stimulating Hormone
Time Frame
Baseline, year 3
Title
Insulin-like Growth Factor Type 1
Time Frame
Baseline, year 3
Title
Inhibin B
Time Frame
Baseline, year 3
Title
Estradiol
Time Frame
Baseline, year 3
Title
Estrone
Time Frame
Baseline, year 3
Title
Number of Adverse Events Related to Acne or Bone Fracture
Time Frame
3 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E Kirk Neely, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura K Bachrach, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Walter A Zegarra, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucile Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25137428
Citation
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.
Results Reference
result
Learn more about this trial
Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole
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