Acromegaly
Conditions
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.
Interventions
None listed
Sponsors
Pfizer
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acromegaly Quality of Life (ACROQoL) Global Score | 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
| Measure | Time frame | Description |
|---|---|---|
| The Gastrointestinal Quality of Life Index (GIQLI) Total Score | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acomegaly With Pegvisomant Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly. | 29 |
| Acromegaly With Somatostatin Analog Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly | 55 |
| Active Acromegaly Patients not on drugs for treatment of acromegaly | 32 |
| Total | 116 |
Baseline characteristics
| Characteristic | Acomegaly With Pegvisomant | Total | Active Acromegaly | Acromegaly With Somatostatin Analog |
|---|---|---|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 16 | 51 years STANDARD_DEVIATION 15 | 50 years STANDARD_DEVIATION 15 | 52 years STANDARD_DEVIATION 13 |
| BMI | 30 kg/m^2 STANDARD_DEVIATION 6 | 30 kg/m^2 STANDARD_DEVIATION 6 | 30 kg/m^2 STANDARD_DEVIATION 5 | 30 kg/m^2 STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 109 Participants | 29 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| IGF-1 Level | 176 ng/ml STANDARD_DEVIATION 58 | 343 ng/ml STANDARD_DEVIATION 277 | 678 ng/ml STANDARD_DEVIATION 221 | 174 ng/ml STANDARD_DEVIATION 51 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 6 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 103 Participants | 28 Participants | 49 Participants |
| Sex: Female, Male Female | 21 Participants | 72 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Male | 8 Participants | 44 Participants | 15 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 60 | 0 / 35 |
| other Total, other adverse events | 0 / 31 | 0 / 60 | 0 / 35 |
| serious Total, serious adverse events | 0 / 31 | 0 / 60 | 0 / 35 |
Outcome results
Primary
Acromegaly Quality of Life (ACROQoL) Global Score
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.
Time frame: Cross-sectional at baseline
Population: Patients receiving either no treatment (active acromegaly), pegvisomant monotherapy or somatostatin analog monotherapy from own doctor to treat acromegaly.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acromegaly With Pegvisomant | Acromegaly Quality of Life (ACROQoL) Global Score | 57 points on a scale | Standard Deviation 19 |
| Acromegaly With Somatostatin Analog | Acromegaly Quality of Life (ACROQoL) Global Score | 60 points on a scale | Standard Deviation 21 |
| Active Acromegaly | Acromegaly Quality of Life (ACROQoL) Global Score | 54 points on a scale | Standard Deviation 22 |
Secondary
36-Item Short Form Survey Instrument (SF-36) Physical Health
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.
Time frame: Cross-sectional at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acromegaly With Pegvisomant | 36-Item Short Form Survey Instrument (SF-36) Physical Health | 60 points on a scale | Standard Deviation 28 |
| Acromegaly With Somatostatin Analog | 36-Item Short Form Survey Instrument (SF-36) Physical Health | 64 points on a scale | Standard Deviation 28 |
| Active Acromegaly | 36-Item Short Form Survey Instrument (SF-36) Physical Health | 63 points on a scale | Standard Deviation 25 |
Secondary
36-Item Short Form Survey (SF-36) Mental Health Summary Score
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.
Time frame: Cross-sectional at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acromegaly With Pegvisomant | 36-Item Short Form Survey (SF-36) Mental Health Summary Score | 58 points on a scale | Standard Deviation 23 |
| Acromegaly With Somatostatin Analog | 36-Item Short Form Survey (SF-36) Mental Health Summary Score | 64 points on a scale | Standard Deviation 25 |
| Active Acromegaly | 36-Item Short Form Survey (SF-36) Mental Health Summary Score | 58 points on a scale | Standard Deviation 26 |
Secondary
The Gastrointestinal Quality of Life Index (GIQLI) Total Score
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.
Time frame: Cross-sectional at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acromegaly With Pegvisomant | The Gastrointestinal Quality of Life Index (GIQLI) Total Score | 100 points on a scale | Standard Deviation 21 |
| Acromegaly With Somatostatin Analog | The Gastrointestinal Quality of Life Index (GIQLI) Total Score | 107 points on a scale | Standard Deviation 24 |
| Active Acromegaly | The Gastrointestinal Quality of Life Index (GIQLI) Total Score | 102 points on a scale | Standard Deviation 22 |