Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-30 @ 12:57 PM
Study NCT ID:
NCT00766532
Status:
COMPLETED
Last Update Posted:
2012-09-14
First Post:
2008-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D047072', 'term': 'Aromatase Inhibitors'}], 'ancestors': [{'id': 'D065088', 'term': 'Steroid Synthesis Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004965', 'term': 'Estrogen Antagonists'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'keh@medicine.wisc.edu', 'phone': '608-263-0517', 'title': 'Dr. Karen Hansen', 'organization': 'University of Wisconsin'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aromatase Inhibitor Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'spread': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 weeks later', 'description': 'intestinal calcium absorption', 'unitOfMeasure': 'percent calcium absorption', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '12 subjects provided informed consent but two dropped and did not undergo calcium absorption study visits. 10 subjects completed all calcium absorption study visits.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm Title- Aromatase Inhibitor Therapy', 'description': 'calcium absorption was measured among subjects at baseline and after taking aromatase inhibitor therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Postmenopausal women with early stage breast cancer and planning to start aromatase inhibitor therapy.', 'preAssignmentDetails': 'Participants completed a four-day food diary'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-13', 'studyFirstSubmitDate': '2008-10-02', 'resultsFirstSubmitDate': '2012-07-06', 'studyFirstSubmitQcDate': '2008-10-02', 'lastUpdatePostDateStruct': {'date': '2012-09-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-13', 'studyFirstPostDateStruct': {'date': '2008-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy', 'timeFrame': 'baseline and 6 weeks later', 'description': 'intestinal calcium absorption'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Osteoporosis', 'Osteopenia', 'Fracture']}, 'referencesModule': {'references': [{'pmid': '22350731', 'type': 'RESULT', 'citation': 'Tevaarwerk A, Burkard ME, Wisinski KB, Shafer MM, Davis LA, Gogineni J, Crone E, Hansen KE. Aromatase inhibitors and calcium absorption in early stage breast cancer. Breast Cancer Res Treat. 2012 Jul;134(1):245-51. doi: 10.1007/s10549-012-1982-z. Epub 2012 Feb 18.'}]}, 'descriptionModule': {'briefSummary': 'Research Question: Do Aromatase Inhibitors Decrease Intestinal Calcium Absorption?\n\nStudy Design: Postmenopausal women with early stage breast cancer initiating aromatase inhibitor adjuvant therapy will participate in this two-month study. The primary study outcome is the change in intestinal calcium absorption following such therapy. Secondary outcomes are the changes in bone resorption markers and musculoskeletal signs and symptoms after initiation of therapy.\n\nWe will interview women and review their medical records to determine eligibility. Eligible subjects will undergo two calcium absorption studies. The first study will determine their baseline calcium absorption, and the second study will occur after taking an aromatase inhibitor daily for at least 6 weeks. Women will present to the research unit in the early morning and receive an oral and intravenous stable calcium tracer with breakfast. Over the next 24 hours, we will collect all urine for measurement of its calcium content. During each inpatient stay, we will assess musculoskeletal symptoms by questionnaire and joint examination. Each woman will complete a four-day diet diary twice during the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women at least 5 years past menopause, defined as date of last menses or bilateral oophorectomy\n* Newly diagnosed breast cancer and starting an AI as initial adjuvant therapy\n\nExclusion Criteria\n\n* Recent, current or planned chemotherapy for breast cancer, as this may have independent effects on intestinal health, calcium homeostasis and bone turnover\n* Allergy or intolerance to orange juice, as one isotope is given with orange juice\n* Current use of over-the-counter or prescription antacids, as they may influence Ca-Ab\n* Intestinal conditions associated with malabsorption or low gastric acid levels including Crohn's disease, ulcerative colitis, pernicious anemia, bacterial overgrowth, celiac sprue, chronic diarrhea or use of antibiotics within the past month\n* Known Stage 4 or 5 Chronic Kidney Disease, defined as an estimated GFR \\<30 cc/minute\n* Use of medications known to interfere with calcium or vitamin D metabolism, including oral steroids or anticonvulsants\n* Significant lymphedema precluding adequate intravenous access"}, 'identificationModule': {'nctId': 'NCT00766532', 'briefTitle': 'Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?', 'orgStudyIdInfo': {'id': 'H-2008-0144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aromatase inhibitor therapy', 'description': 'aromatase inhibitor therapy for six weeks', 'interventionNames': ['Drug: Aromatase Inhibitor']}], 'interventions': [{'name': 'Aromatase Inhibitor', 'type': 'DRUG', 'description': 'Any aromatase inhibitor started as initial adjuvant therapy', 'armGroupLabels': ['aromatase inhibitor therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Karen E Hansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}