Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-20 @ 12:06 PM
Study NCT ID:
NCT02049866
Status:
COMPLETED
Last Update Posted:
2022-12-12
First Post:
2014-01-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
Sponsor:
Organization:
Raw JSON
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{'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mb3523@cumc.columbia.edu', 'phone': '212-305-7225', 'title': 'Mariana Bucovsky', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for 1 year (from baseline to 12 month study participation).', 'eventGroups': [{'id': 'EG000', 'title': 'Denosumab', 'description': 'Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months.\n\nDenosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 26, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fracture', 'notes': 'Nonvertebral fragility fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness', 'notes': 'Redness at injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hair loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Numbness and/or tingling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea and vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in thighs, hips, or groin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Energy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Lumbar Spine Areal BMD by DXA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': 'Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months.\n\nDenosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '33 participants completed baseline but 1 participant withdrew from the study before the 12 month visit.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Lumbar Spine Areal BMD by DXA at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab', 'description': 'Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months.\n\nDenosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months', 'description': 'Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Denosumab', 'description': 'Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months.\n\nDenosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Denosumab', 'description': 'Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months.\n\nDenosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-17', 'size': 334096, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-25T13:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-15', 'studyFirstSubmitDate': '2014-01-28', 'resultsFirstSubmitDate': '2021-03-30', 'studyFirstSubmitQcDate': '2014-01-28', 'lastUpdatePostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-30', 'studyFirstPostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Lumbar Spine Areal BMD by DXA', 'timeFrame': 'Baseline and 12 months', 'description': 'Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Lumbar Spine Areal BMD by DXA at 24 Months', 'timeFrame': 'Baseline and 24 months', 'description': 'Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoporosis', 'premenopausal', 'denosumab', 'idiopathic', 'Idiopathic Osteoporosis in Premenopausal Women'], 'conditions': ['Adult Idiopathic Generalized Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '34849989', 'type': 'DERIVED', 'citation': 'Shane E, Shiau S, Recker RR, Lappe JM, Agarwal S, Kamanda-Kosseh M, Bucovsky M, Stubby J, Cohen A. Denosumab After Teriparatide in Premenopausal Women With Idiopathic Osteoporosis. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1528-e1540. doi: 10.1210/clinem/dgab850.'}], 'seeAlsoLinks': [{'url': 'http://columbiamedicine.org/divisions/Endo/index.shtml', 'label': 'Columbia University, Dept of Medicine, Division of Endocrinology website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis.\n\nPremenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial, "A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women" (NCT01440803) may be eligible to participate in the current study, a 36-month open-label pilot study of denosumab (Prolia®, 60mg subcutaneous (SC) every 6 months).\n\nThe goals of the study are to estimate the effects of denosumab on central and peripheral, as well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data to inform the design of a future randomized study. This study presents the first opportunity to study the effects of denosumab after TPTD in this unique and severely affected group of young women.\n\nFunding Source: FDA Office of Orphan Products Development (OOPD).', 'detailedDescription': 'Osteoporosis in premenopausal women with normal menstrual function and no specific cause is termed idiopathic osteoporosis (IOP). IOP is a rare disease with an estimated prevalence of \\<200,000 affected premenopausal women in the United States.\n\nDenosumab, a potent inhibitor of osteoclast-mediated bone resorption, leads to continuous gains in both trabecular and cortical bone mineral density (BMD). Moreover, denosumab is not retained in the skeleton, and may thus be preferable for use in young women who may be contemplating future pregnancies. The investigators hypothesize that denosumab, initiated after completion of two years of TPTD, will maintain or improve central and peripheral areal and volumetric BMD, microstructure and stiffness in premenopausal women with IOP.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women completing NCT01440803 who remain without a disease or medication that causes osteoporosis will be offered enrollment into this study.\n* (Premenopausal status is no longer be required for entry.)\n\nExclusion Criteria:\n\n* Renal insufficiency or liver disease: Creatinine, transaminase (AST)/alanine transaminase (ALT) above upper limit of normal\n* Vitamin D deficiency: 25-hydroxyvitamin D (25-OHD) \\<30 ng/mL\n* Pregnancy: urine pregnancy test must be negative'}, 'identificationModule': {'nctId': 'NCT02049866', 'briefTitle': 'Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With Idiopathic Osteoporosis (IOP)', 'orgStudyIdInfo': {'id': 'AAAN0161'}, 'secondaryIdInfos': [{'id': '1R01FD005114-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1R01FD005114-01A2', 'type': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Denosumab', 'description': 'Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months.', 'interventionNames': ['Drug: Denosumab']}], 'interventions': [{'name': 'Denosumab', 'type': 'DRUG', 'otherNames': ['Prolia', 'Xgeva'], 'description': 'Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months', 'armGroupLabels': ['Denosumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton University', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Elizabeth Shane, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Adi Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elizabeth Shane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Creighton University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Elizabeth Shane', 'investigatorAffiliation': 'Columbia University'}}}}