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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

Tracking Information
First Submitted Date  ICMJE May 5, 2014
First Posted Date  ICMJE May 14, 2014
Last Update Posted Date November 18, 2014
Study Start Date  ICMJE November 2009
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
Adult height [ Time Frame: 10 years ]
Heights will be obtained at physical exam every 6 months during treatment and annually until final height.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02137538 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
  • Bone density [ Time Frame: 2 years ]
    Baseline and 2 years
  • Spine x-ray [ Time Frame: 2 years ]
    Baseline and 2 years
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole
Official Title  ICMJE Randomization to Letrozole vs. Anastrozole in Short Pubertal Males
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Short Stature
Intervention  ICMJE
  • Drug: Letrozole
  • Drug: Anastrozole
Study Arms  ICMJE
  • Active Comparator: Letrozole
    Letrozole 2.5 mg daily
    Intervention: Drug: Letrozole
  • Active Comparator: Anastrozole
    Anastrozole 1 mg daily
    Intervention: Drug: Anastrozole
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 8, 2014)
80
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: E Kirk Neely, MD 650 723-5791 neely@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02137538
Other Study ID Numbers  ICMJE AI growth study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: E Kirk Neely, MD Stanford University
PRS Account Stanford University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP