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Acromegaly Treatment Quality of Life Study

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.
 
ClinicalTrials.gov Identifier: NCT01732406
Recruitment Status : Completed
First Posted : November 22, 2012
Results First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital

Brief Summary:
The investigators hypothesize that treatment of acromegaly will be associated with an improvement in quality of life compared to active acromegaly. At the same time, they will also be studying the effects of different acromegaly treatments on the quality of life.

Condition or disease
Acromegaly

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Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Growth Hormone Receptor Antagonism and Somatostatin Analog Administration on Quality of Life
Study Start Date : January 2013
Actual Primary Completion Date : December 19, 2016
Actual Study Completion Date : December 19, 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Acomegaly with Pegvisomant
Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.
Acromegaly with somatostatin analog
Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly
Active Acromegaly
Patients not on drugs for treatment of acromegaly



Primary Outcome Measures :
  1. Acromegaly Quality of Life (ACROQoL) Global Score [ Time Frame: Cross-sectional at baseline ]
    The Global Score of the Acromegaly Quality of Life (ACROQoL) Survey measures quality of life in patients with acromegaly. Higher scores indicate better QOL. The range is 22-110 units on a scale.


Secondary Outcome Measures :
  1. The Gastrointestinal Quality of Life Index (GIQLI) Total Score [ Time Frame: Cross-sectional at baseline ]
    The total score for the Gastrointestinal Quality of Life Index (GIQLI) measures quality of life with specific attention to gastrointestinal symptoms. The score ranges from 0-144 points on a scale. Higher scores indicating better quality of life.

  2. 36-Item Short Form Survey Instrument (SF-36) Physical Health [ Time Frame: Cross-sectional at baseline ]
    The Physical Health Summary Score of the SF-36 is a quality of life measure of physical health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Physical Health Summary Score (Physical Component Summary) is calculated as the mean average of the physically relevant questions.

  3. 36-Item Short Form Survey (SF-36) Mental Health Summary Score [ Time Frame: Cross-sectional at baseline ]
    The Mental Health Summary Score of the SF-36 measures quality of life with a focus on mental health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Mental Health Summary Score (Mental Component Summary) is calculated as the mean average of the emotionally relevant questions.


Biospecimen Retention:   Samples Without DNA
Plasma and blood serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
There will be 3 groups/cohorts: 1) Patients with active acromegaly (n=35), 2) patients receiving pegvisomant monotherapy to treat acromegaly (n=31), and 3) patients receiving somatostatin analog monotherapy to treat acromegaly (n=60)
Criteria

Inclusion Criteria:

  • Age 18-90
  • Active acromegaly or receiving pegvisomant monotherapy or receiving somatostatin analog monotherapy

Exclusion Criteria:

  • Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study
  • Initiation or discontinuation of testosterone or estrogen within 3 months of entry
  • Pregnant and nursing women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732406


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Pfizer
Investigators
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Principal Investigator: Karen Miller, MD Massachusetts General Hospital
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Responsible Party: Karen Klahr Miller, MD, Assistant Physician in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01732406    
Other Study ID Numbers: 2012P001556
First Posted: November 22, 2012    Key Record Dates
Results First Posted: April 29, 2019
Last Update Posted: April 29, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases