Trial · Observational

CompletedPhase not statedResults postedRegistry data

Acromegaly Treatment Quality of Life Study

NCTNCT01732406Other id2012P001556

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase not stated
Enrollment: 126 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Not stated
Countries: 1 country
United States
Start: Jan 2013
Primary completion: 19 Dec 2016
Completion: 19 Dec 2016
First posted: 22 Nov 2012 (estimated)
Last update posted: 29 Apr 2019
Conditions: Acromegaly

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20132014201520162017

Ph –
Acromegaly Treatment Quality of Life Study
NCT01732406
Jan 2013 to 19 Dec 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Arms3

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Acromegaly Quality of Life (ACROQoL) Global Score
Time frame · Cross-sectional at baseline
Registry description
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(3)

The Gastrointestinal Quality of Life Index (GIQLI) Total Score
Time frame · Cross-sectional at baseline
Registry description
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
Registry description
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
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Cross-sectional at baseline

Acromegaly Quality of Life (ACROQoL) Global Score

Group	Value (points on a scale)	Spread
Acromegaly With Pegvisomant	57	19
Acromegaly With Somatostatin Analog	60	21
Active Acromegaly	54	22

Secondary and other outcome results(3)

Secondary outcomeMean· Cross-sectional at baseline

The Gastrointestinal Quality of Life Index (GIQLI) Total Score

Group	Value (points on a scale)	Spread
Acomegaly With Pegvisomant	100	21
Acromegaly With Somatostatin Analog	107	24
Active Acromegaly	102	22

Secondary outcomeMean· Cross-sectional at baseline

36-Item Short Form Survey Instrument (SF-36) Physical Health

Group	Value (points on a scale)	Spread
Acromegaly With Pegvisomant	60	28
Acromegaly With Somatostatin Analog	64	28
Active Acromegaly	63	25

Secondary outcomeMean· Cross-sectional at baseline

36-Item Short Form Survey (SF-36) Mental Health Summary Score

Group	Value (points on a scale)	Spread
Acromegaly With Pegvisomant	58	23
Acromegaly With Somatostatin Analog	64	25
Active Acromegaly	58	26

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Acromegaly on PegvisomantPatients receiving pegvisomant monotherapy from own doctor to treat acromegaly.	0 / 31	0 / 31	0 / 31
Acromegaly on Somatostatin AnalogPatients receiving somatostatin analog monotherapy from own doctor to treat acromegaly.	0 / 60	0 / 60	0 / 60
Active AcromegalyPatients receiving no medications to treat active acromegaly.	0 / 35	0 / 35	0 / 35

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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