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OpenTrials
Completed

NCT Number: NCT02137538

Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole

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.

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Key information

Conditions

Short Stature Bone Diseases Bone Diseases, Developmental Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Endocrine System Diseases Genetic Diseases, Inborn Musculoskeletal Diseases

Age range

10 year–17 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Lucile Packard Children's Hospital

Palo Alto, California, 94301, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

letrozole

Drug

Anastrozole

Drug

Primary outcomes

  1. 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).

Secondary outcomes

  1. Serum Testosterone

    Time frame: Baseline, year 3

  2. Dihydrotestosterone

    Time frame: Baseline, year 3

  3. Androstenedione

    Time frame: Baseline, year 3

  4. Luteinizing Hormone

    Time frame: Baseline, year 3

  5. Follicle Stimulating Hormone

    Time frame: Baseline, year 3

  6. Insulin-like Growth Factor Type 1

    Time frame: Baseline, year 3

  7. Inhibin B

    Time frame: Baseline, year 3

  8. Estradiol

    Time frame: Baseline, year 3

  9. Estrone

    Time frame: Baseline, year 3

  10. Number of Adverse Events Related to Acne or Bone Fracture

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Randomization to Letrozole vs. Anastrozole in Short Pubertal Males

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
May 14, 2014
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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