Trial Outcomes & Findings for Acromegaly Treatment Quality of Life Study (NCT NCT01732406)

Last Updated: 2019-04-29

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

126 participants

Primary outcome timeframe

Cross-sectional at baseline

Results posted on

2019-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	31	60	35
Overall Study COMPLETED	31	60	35
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acromegaly Treatment Quality of Life Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acomegaly With Pegvisomant n=29 Participants Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.	Acromegaly With Somatostatin Analog n=55 Participants Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly	Active Acromegaly n=32 Participants Patients not on drugs for treatment of acromegaly	Total n=116 Participants Total of all reporting groups
Age, Continuous	51 years STANDARD_DEVIATION 16 • n=5 Participants	52 years STANDARD_DEVIATION 13 • n=7 Participants	50 years STANDARD_DEVIATION 15 • n=5 Participants	51 years STANDARD_DEVIATION 15 • n=4 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	34 Participants n=7 Participants	17 Participants n=5 Participants	72 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	21 Participants n=7 Participants	15 Participants n=5 Participants	44 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	52 Participants n=7 Participants	29 Participants n=5 Participants	109 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	49 Participants n=7 Participants	28 Participants n=5 Participants	103 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
BMI	30 kg/m^2 STANDARD_DEVIATION 6 • n=5 Participants	30 kg/m^2 STANDARD_DEVIATION 7 • n=7 Participants	30 kg/m^2 STANDARD_DEVIATION 5 • n=5 Participants	30 kg/m^2 STANDARD_DEVIATION 6 • n=4 Participants
IGF-1 Level	176 ng/ml STANDARD_DEVIATION 58 • n=5 Participants	174 ng/ml STANDARD_DEVIATION 51 • n=7 Participants	678 ng/ml STANDARD_DEVIATION 221 • n=5 Participants	343 ng/ml STANDARD_DEVIATION 277 • n=4 Participants

PRIMARY outcome

Timeframe: Cross-sectional at baseline

Population: Patients receiving either no treatment (active acromegaly), pegvisomant monotherapy or somatostatin analog monotherapy from own doctor to treat acromegaly.

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.

Outcome measures

Outcome measures
Measure	Acromegaly With Pegvisomant n=29 Participants No adverse events were experienced in this study.	Acromegaly With Somatostatin Analog n=55 Participants No adverse events were experienced in this study.	Active Acromegaly n=32 Participants No adverse events were experienced in this study.
Acromegaly Quality of Life (ACROQoL) Global Score	57 points on a scale Standard Deviation 19	60 points on a scale Standard Deviation 21	54 points on a scale Standard Deviation 22

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Acromegaly With Pegvisomant n=29 Participants No adverse events were experienced in this study.	Acromegaly With Somatostatin Analog n=55 Participants No adverse events were experienced in this study.	Active Acromegaly n=32 Participants No adverse events were experienced in this study.
The Gastrointestinal Quality of Life Index (GIQLI) Total Score	100 points on a scale Standard Deviation 21	107 points on a scale Standard Deviation 24	102 points on a scale Standard Deviation 22

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Acromegaly With Pegvisomant n=29 Participants No adverse events were experienced in this study.	Acromegaly With Somatostatin Analog n=55 Participants No adverse events were experienced in this study.	Active Acromegaly n=32 Participants No adverse events were experienced in this study.
36-Item Short Form Survey Instrument (SF-36) Physical Health	60 points on a scale Standard Deviation 28	64 points on a scale Standard Deviation 28	63 points on a scale Standard Deviation 25

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Acromegaly With Pegvisomant n=29 Participants No adverse events were experienced in this study.	Acromegaly With Somatostatin Analog n=55 Participants No adverse events were experienced in this study.	Active Acromegaly n=32 Participants No adverse events were experienced in this study.
36-Item Short Form Survey (SF-36) Mental Health Summary Score	58 points on a scale Standard Deviation 23	64 points on a scale Standard Deviation 25	58 points on a scale Standard Deviation 26

Adverse Events

Acromegaly on Pegvisomant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acromegaly on Somatostatin Analog

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Acromegaly

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Karen Miller

Massachusetts General Hospital

Phone: 617-726-3870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place