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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Cross-sectional at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Cross-sectional at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Karen Miller, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acomegaly With Pegvisomant | Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly. |
| FG001 | Acromegaly With Somatostatin Analog | Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly |
| FG002 | Active Acromegaly | Patients not on drugs for treatment of acromegaly |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects with IGF-1 levels not consistent with assigned group were excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | Acomegaly With Pegvisomant | Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly. |
| BG001 | Acromegaly With Somatostatin Analog | Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients receiving either no treatment (active acromegaly), pegvisomant monotherapy or somatostatin analog monotherapy from own doctor to treat acromegaly. | Posted | Mean | Standard Deviation | points on a scale | Cross-sectional at baseline |
|
This was a cross-sectional study. Adverse events were collected at the baseline cross-sectional visit for each subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acromegaly on Pegvisomant | Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Miller | Massachusetts General Hospital | 617-726-3870 | kkmiller@partners.org |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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Plasma and blood serum
| 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. |
| Cross-sectional at baseline |
| 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. | Cross-sectional at baseline |
| BG002 | Active Acromegaly | Patients not on drugs for treatment of acromegaly |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| IGF-1 Level | Mean | Standard Deviation | ng/ml |
|
| OG002 | Active Acromegaly | No adverse events were experienced in this study. |
|
|
| 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. | Posted | Mean | Standard Deviation | points on a scale | Cross-sectional at baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points on a scale | Cross-sectional at baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points on a scale | Cross-sectional at baseline |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Acromegaly on Somatostatin Analog | Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly. | 0 | 60 | 0 | 60 | 0 | 60 |
| EG002 | Active Acromegaly | Patients receiving no medications to treat active acromegaly. | 0 | 35 | 0 | 35 | 0 | 35 |
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| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |