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Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anne Klibanski, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00182091
First received: September 14, 2005
Last updated: April 26, 2012
Last verified: April 2012
Results First Received: February 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Acromegaly
Growth Hormone Deficiency
Pituitary Disease
Interventions: Drug: Recombinant human growth hormone
Drug: Saline

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
AcroGHD Randomized to Growth Hormone Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
AcroGHD Randomized to Placebo Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
AcroGHS Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
Active Acromegaly Subjects with active acromegaly. This is not an interventional arm.

Participant Flow:   Overall Study
    AcroGHD Randomized to Growth Hormone     AcroGHD Randomized to Placebo     AcroGHS     Active Acromegaly  
STARTED     15     15     25     20  
COMPLETED     14     15     25     20  
NOT COMPLETED     1     0     0     0  
Withdrawal by Subject                 1                 0                 0                 0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
AcroGHD Randomized to Growth Hormone Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
AcroGHD Randomized to Placebo Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
AcroGHS Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
Active Acromegaly Subjects with active acromegaly. This is not an interventional arm.
Total Total of all reporting groups

Baseline Measures
    AcroGHD Randomized to Growth Hormone     AcroGHD Randomized to Placebo     AcroGHS     Active Acromegaly     Total  
Number of Participants  
[units: participants]
  15     15     25     20     75  
Age  
[units: years]
Mean ± Standard Deviation
  47  ± 12     47  ± 11     47  ± 12     46  ± 14     46  ± 12  
Gender  
[units: participants]
         
Female     9     8     18     10     45  
Male     6     7     7     10     30  



  Outcome Measures
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1.  Primary:   Change in High-sensitivity C-reactive Protein   [ Time Frame: baseline and 6 months ]

2.  Secondary:   Change in Total Fat Mass   [ Time Frame: baseline and 6 months ]

3.  Secondary:   Change in Total Abdominal Adipose Tissue   [ Time Frame: baseline and 6 months ]

4.  Secondary:   Change in Visceral Abdominal Adipose Tissue   [ Time Frame: baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Anne Klibanski
Organization: Massachusetts General Hospital
phone: 617-726-3870


Publications of Results:

Responsible Party: Anne Klibanski, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00182091     History of Changes
Other Study ID Numbers: 2004p-001078
Study First Received: September 14, 2005
Results First Received: February 7, 2012
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration