Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole

NCT02137538 | Completed Phase 4 Results

• 1 other identifier: AI growth study
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Stature

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Serum Testosterone

  Baseline, year 3

• Dihydrotestosterone

  Baseline, year 3

• Androstenedione

  Baseline, year 3

• Luteinizing Hormone

  Baseline, year 3

• Follicle Stimulating Hormone

  Baseline, year 3

Study Arms (2)

Letrozole

ACTIVE COMPARATOR

Letrozole 2.5 mg daily

Drug: Letrozole

Anastrozole

ACTIVE COMPARATOR

Anastrozole 1 mg daily

Drug: Anastrozole

Interventions

Letrozole DRUG

Letrozole

Anastrozole DRUG

Anastrozole

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Bone age reading more than 14.0 years
• Follicle stimulating hormone \> 20 IU/L

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94301, United States

Location

Related Publications (1)

• 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.

  PMID: 25137428 RESULT

MeSH Terms

Conditions

Dwarfism

Interventions

Letrozole; Anastrozole

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: E Kirk Neely
• Organization: Stanford University

neely@stanford.edu

650-723-5791

Study Officials

• E Kirk Neely, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Laura K Bachrach, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Walter A Zegarra, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 14, 2014
• Study Start: November 18, 2009
• Primary Completion: June 5, 2018
• Study Completion: June 5, 2018
• Last Updated: July 15, 2021
• Results First Posted: July 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)