Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00283595
Recruitment Status : Completed
First Posted : January 30, 2006
Results First Posted : October 16, 2012
Last Update Posted : October 16, 2012
Genentech, Inc.
Information provided by (Responsible Party):
Anne Klibanski, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions: Anorexia Nervosa
Eating Disorders
Interventions: Drug: Recombinant Human Growth Hormone
Drug: Placebo for Recombinant Human 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
Subjects were referred from by local eating disorders providers and were recruited from on-line advertisements. Recruitment period: April 2006 through November 2008.

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

Reporting Groups
Recombinant Human Growth Hormone(Subcutaneous Daily Injection) Treatment with rHGH
Placebo (Subcutaneous Daily Injection) Treatment with Placebo

Participant Flow:   Overall Study
    Recombinant Human Growth Hormone(Subcutaneous Daily Injection)   Placebo (Subcutaneous Daily Injection)
STARTED   10   11 
COMPLETED   9   9 
Withdrawal by Subject                1                2 

  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
Recombinant Human Growth Hormone Group Treatment with rHGH
Placebo Group Treatment with Placebo
Total Total of all reporting groups

Baseline Measures
   Recombinant Human Growth Hormone Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   11   21 
[Units: Years]
Mean (Standard Deviation)
 28.0  (6.7)   29.2  (8.6)   28.7  (7.5) 
[Units: Participants]
Female   10   11   21 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
United States   10   11   21 

  Outcome Measures

1.  Primary:   Bone Metabolism   [ Time Frame: Baseline, 12 weeks ]

2.  Secondary:   IGF-1 Level   [ Time Frame: Baseline, 12 Weeks ]

  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: Anne Klibanski, MD
Organization: Massachusetts General Hospital
phone: 617-726-3870

Responsible Party: Anne Klibanski, MD, Massachusetts General Hospital Identifier: NCT00283595     History of Changes
Other Study ID Numbers: 2005-P-001443/3; MGH
First Submitted: January 27, 2006
First Posted: January 30, 2006
Results First Submitted: August 16, 2012
Results First Posted: October 16, 2012
Last Update Posted: October 16, 2012