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Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Anne Klibanski, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00283595
First received: January 27, 2006
Last updated: September 15, 2012
Last verified: September 2012
History of Changes
Results First Received: August 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Anorexia Nervosa
Osteopenia
Osteoporosis
Eating Disorders
Interventions: Drug: Recombinant Human Growth Hormone
Drug: Placebo for Recombinant Human Growth Hormone

  Participant Flow
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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
  Description
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  
NOT COMPLETED     1     2  
Withdrawal by Subject                 1                 2  



  Baseline Characteristics
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Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
 		  10     11     21  
Age  
[units: years]
Mean ± Standard Deviation 		  28.0  ± 6.7     29.2  ± 8.6     28.7  ± 7.5  
Gender  
[units: participants]
 		     
Female     10     11     21  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     10     11     21  



  Outcome Measures
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1.  Primary:   Bone Metabolism   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 1

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


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


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.  


Results Point of Contact:  
Name/Title: Anne Klibanski, MD
Organization: Massachusetts General Hospital
phone: 617-726-3870
e-mail: aklibanski@partners.org


No publications provided


Responsible Party: Anne Klibanski, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00283595     History of Changes
Other Study ID Numbers: 2005-P-001443/3; MGH
Study First Received: January 27, 2006
Results First Received: August 16, 2012
Last Updated: September 15, 2012
Health Authority: United States: Institutional Review Board