Acromegaly Treatment Quality of Life Study

January 25, 2019 updated by: Karen Klahr Miller, MD, Massachusetts General Hospital

Effect of Growth Hormone Receptor Antagonism and Somatostatin Analog Administration on Quality of Life

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Cross-sectional at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Cross-sectional at baseline
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.
Cross-sectional at baseline
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.
Cross-sectional at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Pfizer

Investigators

  • Principal Investigator: Karen Miller, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 19, 2016

Study Completion (Actual)

December 19, 2016

Study Registration Dates

First Submitted

November 19, 2012

First Submitted That Met QC Criteria

November 19, 2012

First Posted (Estimate)

November 22, 2012

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012P001556

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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