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Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole

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ClinicalTrials.gov Identifier: NCT02137538
Recruitment Status : Recruiting
First Posted : May 14, 2014
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Short Stature Drug: Letrozole Drug: Anastrozole Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomization to Letrozole vs. Anastrozole in Short Pubertal Males
Study Start Date : November 2009
Estimated Primary Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Letrozole
Letrozole 2.5 mg daily
Drug: Letrozole
Active Comparator: Anastrozole
Anastrozole 1 mg daily
Drug: Anastrozole



Primary Outcome Measures :
  1. Adult height [ Time Frame: 10 years ]
    Heights will be obtained at physical exam every 6 months during treatment and annually until final height.


Secondary Outcome Measures :
  1. Bone density [ Time Frame: 2 years ]
    Baseline and 2 years

  2. Spine x-ray [ Time Frame: 2 years ]
    Baseline and 2 years

  3. Change in bone age [ Time Frame: 3 years ]
    Bone ages will be obtained at baseline and annually during therapy. to calculate interim predicted adult heights.

  4. testosterone [ Time Frame: 0.5 to 4 years ]
    At baseline, every 6 months, and 1 year post-treatment, we will obtain serum levels of testosterone

  5. dihydrotestosterone [ Time Frame: 0.5 to 4 years ]
    At baseline, every 6 months, and 1 year post-treatment, we will obtain serum levels of dihydrotestosterone

  6. androstenedione [ Time Frame: 0.5 to 4 years ]
    At baseline, every 6 months, and 1 year post-treatment, we will obtain serum levels of androstenedione

  7. estradiol [ Time Frame: 0.5 to 4 years ]
    At baseline, every 6 months, and 1 year post-treatment, we will obtain serum levels of estradiol

  8. estrone [ Time Frame: 0.5 to 4 years ]
    At baseline, every 6 months, and 1 year post-treatment, we will obtain serum levels of estrone

  9. inhibin B [ Time Frame: 0.5 to 4 years ]
    At baseline, every 6 months, and 1 year post-treatment, we will obtain serum levels of inhibin B

  10. luteinizing hormone [ Time Frame: 0.5 to 4 years ]
    At baseline, every 6 months, and 1 year post-treatment, we will obtain serum levels of luteinizing hormone

  11. follicle stimulating hormone [ Time Frame: 0.5 to 4 years ]
    At baseline, every 6 months, and 1 year post-treatment, we will obtain serum levels of follicle stimulating hormone

  12. insulin-like growth factor 1 [ Time Frame: 0.5 to 4 years ]
    At baseline, every 6 months, and 1 year post-treatment, we will obtain serum levels of insulin-like growth factor 1

  13. insulin-like growth factor binding protein 3 [ Time Frame: 0.5 to 4 years ]
    At baseline, every 6 months, and 1 year post-treatment, we will obtain serum levels of insulin-like growth factor binding protein 3



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137538


Contacts
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Contact: E Kirk Neely, MD 650 723-5791 neely@stanford.edu

Locations
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United States, California
Lucile Packard Children's Hospital Recruiting
Palo Alto, California, United States, 94301
Contact: E Kirk Neely, MD    650-723-5791      
Principal Investigator: E Kirk Neely, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: E Kirk Neely, MD Stanford University

Publications of Results:
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02137538     History of Changes
Other Study ID Numbers: AI growth study
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Letrozole
Anastrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal