Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-01-14 @ 3:58 AM
Study NCT ID:
NCT01732406
Status:
COMPLETED
Last Update Posted:
2019-04-29
First Post:
2012-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acromegaly Treatment Quality of Life Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000172', 'term': 'Acromegaly'}], 'ancestors': [{'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006964', 'term': 'Hyperpituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kkmiller@partners.org', 'phone': '617-726-3870', 'title': 'Dr. Karen Miller', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'This was a cross-sectional study. Adverse events were collected at the baseline cross-sectional visit for each subject.', 'eventGroups': [{'id': 'EG000', 'title': 'Acromegaly on Pegvisomant', 'description': 'Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Acromegaly on Somatostatin Analog', 'description': 'Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Active Acromegaly', 'description': 'Patients receiving no medications to treat active acromegaly.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acromegaly Quality of Life (ACROQoL) Global Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acromegaly With Pegvisomant', 'description': 'No adverse events were experienced in this study.'}, {'id': 'OG001', 'title': 'Acromegaly With Somatostatin Analog', 'description': 'No adverse events were experienced in this study.'}, {'id': 'OG002', 'title': 'Active Acromegaly', 'description': 'No adverse events were experienced in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '19', 'groupId': 'OG000'}, {'value': '60', 'spread': '21', 'groupId': 'OG001'}, {'value': '54', 'spread': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cross-sectional at baseline', '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.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients receiving either no treatment (active acromegaly), pegvisomant monotherapy or somatostatin analog monotherapy from own doctor to treat acromegaly.'}, {'type': 'SECONDARY', 'title': 'The Gastrointestinal Quality of Life Index (GIQLI) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acomegaly With Pegvisomant', 'description': 'Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.'}, {'id': 'OG001', 'title': 'Acromegaly With Somatostatin Analog', 'description': 'Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly'}, {'id': 'OG002', 'title': 'Active Acromegaly', 'description': 'Patients not on drugs for treatment of acromegaly'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'spread': '21', 'groupId': 'OG000'}, {'value': '107', 'spread': '24', 'groupId': 'OG001'}, {'value': '102', 'spread': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cross-sectional at baseline', '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.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey Instrument (SF-36) Physical Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acromegaly With Pegvisomant', 'description': 'Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.'}, {'id': 'OG001', 'title': 'Acromegaly With Somatostatin Analog', 'description': 'Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly'}, {'id': 'OG002', 'title': 'Active Acromegaly', 'description': 'Patients not on drugs for treatment of acromegaly'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '28', 'groupId': 'OG000'}, {'value': '64', 'spread': '28', 'groupId': 'OG001'}, {'value': '63', 'spread': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cross-sectional at baseline', '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.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey (SF-36) Mental Health Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acromegaly With Pegvisomant', 'description': 'Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.'}, {'id': 'OG001', 'title': 'Acromegaly With Somatostatin Analog', 'description': 'Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly'}, {'id': 'OG002', 'title': 'Active Acromegaly', 'description': 'Patients not on drugs for treatment of acromegaly'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '23', 'groupId': 'OG000'}, {'value': '64', 'spread': '25', 'groupId': 'OG001'}, {'value': '58', 'spread': '26', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cross-sectional at baseline', '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.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acomegaly With Pegvisomant', 'description': 'Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.'}, {'id': 'FG001', 'title': 'Acromegaly With Somatostatin Analog', 'description': 'Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly'}, {'id': 'FG002', 'title': 'Active Acromegaly', 'description': 'Patients not on drugs for treatment of acromegaly'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Acomegaly With Pegvisomant', 'description': 'Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.'}, {'id': 'BG001', 'title': 'Acromegaly With Somatostatin Analog', 'description': 'Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly'}, {'id': 'BG002', 'title': 'Active Acromegaly', 'description': 'Patients not on drugs for treatment of acromegaly'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '16', 'groupId': 'BG000'}, {'value': '52', 'spread': '13', 'groupId': 'BG001'}, {'value': '50', 'spread': '15', 'groupId': 'BG002'}, {'value': '51', 'spread': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '6', 'groupId': 'BG000'}, {'value': '30', 'spread': '7', 'groupId': 'BG001'}, {'value': '30', 'spread': '5', 'groupId': 'BG002'}, {'value': '30', 'spread': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'IGF-1 Level', 'classes': [{'categories': [{'measurements': [{'value': '176', 'spread': '58', 'groupId': 'BG000'}, {'value': '174', 'spread': '51', 'groupId': 'BG001'}, {'value': '678', 'spread': '221', 'groupId': 'BG002'}, {'value': '343', 'spread': '277', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Subjects with IGF-1 levels not consistent with assigned group were excluded.'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma and blood serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-25', 'studyFirstSubmitDate': '2012-11-19', 'resultsFirstSubmitDate': '2017-11-02', 'studyFirstSubmitQcDate': '2012-11-19', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-25', 'studyFirstPostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acromegaly Quality of Life (ACROQoL) Global Score', 'timeFrame': 'Cross-sectional at baseline', '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.'}], 'secondaryOutcomes': [{'measure': 'The Gastrointestinal Quality of Life Index (GIQLI) Total Score', 'timeFrame': 'Cross-sectional at baseline', '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.'}, {'measure': '36-Item Short Form Survey Instrument (SF-36) Physical Health', 'timeFrame': 'Cross-sectional at baseline', '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.'}, {'measure': '36-Item Short Form Survey (SF-36) Mental Health Summary Score', 'timeFrame': 'Cross-sectional at baseline', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acromegaly']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-90\n* Active acromegaly or receiving pegvisomant monotherapy or receiving somatostatin analog monotherapy\n\nExclusion Criteria:\n\n* Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study\n* Initiation or discontinuation of testosterone or estrogen within 3 months of entry\n* Pregnant and nursing women'}, 'identificationModule': {'nctId': 'NCT01732406', 'briefTitle': 'Acromegaly Treatment Quality of Life Study', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Effect of Growth Hormone Receptor Antagonism and Somatostatin Analog Administration on Quality of Life', 'orgStudyIdInfo': {'id': '2012P001556'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acomegaly with Pegvisomant', 'description': 'Patients receiving pegvisomant monotherapy from own doctor to treat acromegaly.'}, {'label': 'Acromegaly with somatostatin analog', 'description': 'Patients receiving somatostatin analog monotherapy from own doctor to treat acromegaly'}, {'label': 'Active Acromegaly', 'description': 'Patients not on drugs for treatment of acromegaly'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Karen Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Physician in Medicine', 'investigatorFullName': 'Karen Klahr Miller, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}