Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole

June 24, 2021 updated by: Laura K Bachrach, Stanford University

Randomization to Letrozole vs. Anastrozole in Short Pubertal Males

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94301
        • Lucile Packard Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Letrozole
Letrozole 2.5 mg daily
Drug: Letrozole
Active Comparator: Anastrozole
Anastrozole 1 mg daily
Drug: Anastrozole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predicted Adult Height at Year 3
Time Frame: 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 Outcome Measures

Outcome Measure
Time Frame
Serum Testosterone
Time Frame: Baseline, year 3
Baseline, year 3
Dihydrotestosterone
Time Frame: Baseline, year 3
Baseline, year 3
Androstenedione
Time Frame: Baseline, year 3
Baseline, year 3
Luteinizing Hormone
Time Frame: Baseline, year 3
Baseline, year 3
Follicle Stimulating Hormone
Time Frame: Baseline, year 3
Baseline, year 3
Insulin-like Growth Factor Type 1
Time Frame: Baseline, year 3
Baseline, year 3
Inhibin B
Time Frame: Baseline, year 3
Baseline, year 3
Estradiol
Time Frame: Baseline, year 3
Baseline, year 3
Estrone
Time Frame: Baseline, year 3
Baseline, year 3
Number of Adverse Events Related to Acne or Bone Fracture
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: E Kirk Neely, MD, Stanford University
  • Principal Investigator: Laura K Bachrach, MD, Stanford University
  • Principal Investigator: Walter A Zegarra, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2009

Primary Completion (Actual)

June 5, 2018

Study Completion (Actual)

June 5, 2018

Study Registration Dates

First Submitted

May 5, 2014

First Submitted That Met QC Criteria

May 8, 2014

First Posted (Estimate)

May 14, 2014

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

June 24, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI growth study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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