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Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature (ThrasherAI)

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ClinicalTrials.gov Identifier: NCT01248416
Recruitment Status : Completed
First Posted : November 25, 2010
Results First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Collaborators:
Thrasher Research Fund
Genentech, Inc.
Novartis
AstraZeneca
Pfizer
Information provided by (Responsible Party):
Nelly Mauras, Nemours Children's Clinic

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Idiopathic Short Stature
Interventions: Drug: Aromatase Inhibitor
Drug: Growth Hormone
Drug: Aromatase Inhibitor and Growth Hormone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Aromatase Inhibitor

Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years

Aromatase Inhibitor

Growth Hormone

Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years

Growth Hormone

Aromatase Inhibitor and Growth Hormone

Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years

Aromatase Inhibitor

Growth Hormone

Aromatase Inhibitor and Growth Hormone


Participant Flow:   Overall Study
    Aromatase Inhibitor   Growth Hormone   Aromatase Inhibitor and Growth Hormone
STARTED   25   25   26 
COMPLETED   21   25   25 
NOT COMPLETED   4   0   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aromatase Inhibitor

Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years

Aromatase Inhibitor

Growth Hormone

Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years

Growth Hormone

Aromatase Inhibitor and Growth Hormone

Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years

Aromatase Inhibitor

Growth Hormone

Aromatase Inhibitor and Growth Hormone

Total Total of all reporting groups

Baseline Measures
   Aromatase Inhibitor   Growth Hormone   Aromatase Inhibitor and Growth Hormone   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   26   76 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.2  (1.0)   14.1  (1.2)   14.0  (1.1)   14.1  (1.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      25 100.0%      25 100.0%      26 100.0%      76 100.0% 


  Outcome Measures

1.  Primary:   Change in Height   [ Time Frame: 0 to 24 months ]

2.  Primary:   Change in Predicted Height   [ Time Frame: 0 to 24 months ]

3.  Secondary:   Change in Bone Density z Score Adjusted for Height   [ Time Frame: 0 to 24 months ]

4.  Secondary:   Change in Lean Body Mass   [ Time Frame: 0 to 24 months ]

5.  Secondary:   Change in Body Mass Index   [ Time Frame: 0 to 24 months ]

6.  Secondary:   Change in IGF-I Concentrations   [ Time Frame: 0 to 24 months ]

7.  Secondary:   Change in Testosterone   [ Time Frame: 0 to 24 months ]

8.  Secondary:   Change in Estradiol   [ Time Frame: 0 to 24 months ]

9.  Secondary:   Change in Estrone   [ Time Frame: 0 to 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Nelly Mauras
Organization: Nemours Children's Clinic
phone: 904-697-3674
e-mail: nmauras@nemours.org


Publications of Results:

Responsible Party: Nelly Mauras, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT01248416     History of Changes
Other Study ID Numbers: 180984
First Submitted: November 2, 2010
First Posted: November 25, 2010
Results First Submitted: October 29, 2017
Results First Posted: June 7, 2018
Last Update Posted: June 7, 2018