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Clinical Trials/NCT01732406
NCT01732406
Completed
Not Applicable

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

Massachusetts General Hospital1 site in 1 country126 target enrollmentJanuary 2013
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ConditionsAcromegaly

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acromegaly
Sponsor
Massachusetts General Hospital
Enrollment
126
Locations
1
Primary Endpoint
Acromegaly Quality of Life (ACROQoL) Global Score
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
December 19, 2016
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen Klahr Miller, MD

Assistant Physician in Medicine

Massachusetts General Hospital

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

Outcomes

Primary Outcomes

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 Outcomes

  • The Gastrointestinal Quality of Life Index (GIQLI) Total Score(Cross-sectional at baseline)
  • 36-Item Short Form Survey Instrument (SF-36) Physical Health(Cross-sectional at baseline)
  • 36-Item Short Form Survey (SF-36) Mental Health Summary Score(Cross-sectional at baseline)

Study Sites (1)

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