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Trial record 1 of 1 for:    NCT01732406
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Acromegaly Treatment Quality of Life Study

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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

Tracking Information
First Submitted Date November 19, 2012
First Posted Date November 22, 2012
Results First Submitted Date November 2, 2017
Results First Posted Date April 29, 2019
Last Update Posted Date April 29, 2019
Study Start Date January 2013
Actual Primary Completion Date December 19, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2019)
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.
Original Primary Outcome Measures
 (submitted: November 19, 2012)
Quality of Life [ Time Frame: basline ]
Short-form Health survey (SF-36), Gastrointestinal quality of life index (GIQLI), and Acromegaly Quality of Life questionnaire (AcroQoL)
Change History
Current Secondary Outcome Measures
 (submitted: January 25, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: November 19, 2012)
  • Glucose Homeostasis [ Time Frame: basline ]
    Fasting glucose, insulin levels, homeostatic model assessment, Hemoglobin A1c (HbA1c), 75-gram oral glucose tolerance test (OGTT), and quantitative insulin sensitivity check index (QUICKI)
  • Endocrine Testing [ Time Frame: Baseline ]
    Serum IGF-1 levels, total testosterone, free testosterone, free thyroxine (T4)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acromegaly Treatment Quality of Life Study
Official Title Effect of Growth Hormone Receptor Antagonism and Somatostatin Analog Administration on Quality of Life
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma and blood serum
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)
Condition Acromegaly
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 25, 2019)
126
Original Estimated Enrollment
 (submitted: November 19, 2012)
120
Actual Study Completion Date December 19, 2016
Actual Primary Completion Date December 19, 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01732406
Other Study ID Numbers 2012P001556
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Karen Klahr Miller, MD, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Pfizer
Investigators
Principal Investigator: Karen Miller, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date January 2019