Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-03 @ 10:22 PM
Study NCT ID:
NCT04026256
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2019-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019379', 'term': 'Teriparatide'}, {'id': 'D000069448', 'term': 'Denosumab'}], 'ancestors': [{'id': 'D010281', 'term': 'Parathyroid Hormone'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bzleder@mgh.harvard.edu', 'phone': '617-724-2039', 'title': 'Benjamin Leder', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'adverse event data was collected from baseline to approximately 1 month after study completion, for an average duration of 5 months per participant (assuming that the participant completed the whole study).', 'eventGroups': [{'id': 'EG000', 'title': 'Teriparatide Only', 'description': 'daily subcutaneous injection teriparatide for 3 months\n\nTeriparatide: teriparatide daily subcutaneous injection', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 5, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Denosumab Only', 'description': 'one dose of subcutaneous injection denosumab\n\nDenosumab: denosumab subcutaneous injection', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 6, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Denosumab and Teriparatide', 'description': 'daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab\n\nTeriparatide: teriparatide daily subcutaneous injection\n\nDenosumab: denosumab subcutaneous injection', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'propagation of fracture at biopsy site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'phototoxic dermatitis', 'notes': 'phototoxic dermatitis likely secondary to demeclocycline used for biopsy labelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'transient syncopal event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cancellous Bone Formation Rate at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide Only', 'description': 'daily subcutaneous injection teriparatide for 3 months\n\nTeriparatide: teriparatide daily subcutaneous injection'}, {'id': 'OG001', 'title': 'Denosumab Only', 'description': 'one dose of subcutaneous injection denosumab\n\nDenosumab: denosumab subcutaneous injection'}, {'id': 'OG002', 'title': 'Denosumab and Teriparatide', 'description': 'daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab\n\nTeriparatide: teriparatide daily subcutaneous injection\n\nDenosumab: denosumab subcutaneous injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.02', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after first dose of study drug', 'description': 'Cancellous bone formation rate at month 3 is calculated from the cancellous (trabecular) compartment of the iliac crest bone biopsy specimens.\n\nBone formation rate (BFR/BS, mm3/mm2/day): amount of new bone formed in unit time per unit of bone surface. It is calculated by multiplying the mineralizing surface/bone surface (MS/BS) by the mineral apposition rate (MAR) - see below for how MS/BS and MAR are calculated.\n\nMineralizing surface (MS/BS, %): is the percent of bone surface that displays a tetracycline label reflecting active mineralization. It is calculated as the double-labeled surface plus one half of the single-labeled surface and is expressed as a function of total bone surface. It is a measure of the proportion of bone surface upon which new mineralized bone was being deposited during the period of tetracycline labeling.\n\nMineral apposition rate (MAR mm/day): is the mean distance between the double labels, divided by the time interval between them.', 'unitOfMeasure': 'mm3/mm2/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'refers to number of subjects who had bone biopsies available for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Teriparatide Only', 'description': 'daily subcutaneous injection teriparatide for 3 months\n\nTeriparatide: teriparatide daily subcutaneous injection'}, {'id': 'FG001', 'title': 'Denosumab Only', 'description': 'one dose of subcutaneous injection denosumab\n\nDenosumab: denosumab subcutaneous injection'}, {'id': 'FG002', 'title': 'Denosumab and Teriparatide', 'description': 'daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab\n\nTeriparatide: teriparatide daily subcutaneous injection\n\nDenosumab: denosumab subcutaneous injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': '37 participants enrolled in the study. 3 participants withdrew their consent very soon after signing the consent form and PRIOR to randomization to a treatment arm. Thus we are reporting this as 37 enrolled in the study and 34 enrolled AND randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Teriparatide Only', 'description': 'daily subcutaneous injection teriparatide for 3 months\n\nTeriparatide: teriparatide daily subcutaneous injection'}, {'id': 'BG001', 'title': 'Denosumab Only', 'description': 'one dose of subcutaneous injection denosumab\n\nDenosumab: denosumab subcutaneous injection'}, {'id': 'BG002', 'title': 'Denosumab and Teriparatide', 'description': 'daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab\n\nTeriparatide: teriparatide daily subcutaneous injection\n\nDenosumab: denosumab subcutaneous injection'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '79'}, {'value': '64', 'groupId': 'BG001', 'lowerLimit': '55', 'upperLimit': '71'}, {'value': '65', 'groupId': 'BG002', 'lowerLimit': '55', 'upperLimit': '72'}, {'value': '66', 'groupId': 'BG003', 'lowerLimit': '50', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '31', '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': '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', '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': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', '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': 'Lumbar Spine bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA) (g/cm2)', 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'spread': '0.09', 'groupId': 'BG000'}, {'value': '0.80', 'spread': '0.09', 'groupId': 'BG001'}, {'value': '0.81', 'spread': '0.06', 'groupId': 'BG002'}, {'value': '0.83', 'spread': '0.08', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/cm2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Femoral Neck BMD by DXA (g/cm2)', 'classes': [{'categories': [{'measurements': [{'value': '0.62', 'spread': '0.07', 'groupId': 'BG000'}, {'value': '0.64', 'spread': '0.06', 'groupId': 'BG001'}, {'value': '0.60', 'spread': '0.08', 'groupId': 'BG002'}, {'value': '0.62', 'spread': '0.07', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/cm2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Hip BMD by DXA (g/cm2)', 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'spread': '0.11', 'groupId': 'BG000'}, {'value': '0.73', 'spread': '0.08', 'groupId': 'BG001'}, {'value': '0.72', 'spread': '0.10', 'groupId': 'BG002'}, {'value': '0.74', 'spread': '0.10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/cm2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'refers to subjects enrolled and randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-11', 'size': 818287, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-25T14:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2019-07-17', 'resultsFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2019-07-17', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-01', 'studyFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cancellous Bone Formation Rate at Month 3', 'timeFrame': '3 months after first dose of study drug', 'description': 'Cancellous bone formation rate at month 3 is calculated from the cancellous (trabecular) compartment of the iliac crest bone biopsy specimens.\n\nBone formation rate (BFR/BS, mm3/mm2/day): amount of new bone formed in unit time per unit of bone surface. It is calculated by multiplying the mineralizing surface/bone surface (MS/BS) by the mineral apposition rate (MAR) - see below for how MS/BS and MAR are calculated.\n\nMineralizing surface (MS/BS, %): is the percent of bone surface that displays a tetracycline label reflecting active mineralization. It is calculated as the double-labeled surface plus one half of the single-labeled surface and is expressed as a function of total bone surface. It is a measure of the proportion of bone surface upon which new mineralized bone was being deposited during the period of tetracycline labeling.\n\nMineral apposition rate (MAR mm/day): is the mean distance between the double labels, divided by the time interval between them.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoporosis', 'histomorphometry', 'bone density', 'teriparatide', 'denosumab'], 'conditions': ['Postmenopausal Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3 months of treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women aged 45+\n* postmenopausal\n* osteoporotic with high risk of fracture\n\nExclusion Criteria:\n\n* significant previous use of bone health modifying treatments\n* known congenital or acquired bone disease other than osteoporosis\n* significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease\n* abnormal calcium or parathyroid hormone level\n* serum vitamin D \\<20 ng/mL or \\>60ng/mL\n* serum alkaline phosphatase above upper normal limit with no explanation\n* anemia (hematocrit \\<32%)\n* history of malignancy (except non-melanoma skin carcinoma), radiation therapy, or gouty arthritis\n* history of urolithiasis within the last one year\n* excessive alcohol use or substance abuse\n* use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months\n* extensive dental work involving extraction or dental implant within the past or upcoming 2 months\n* known sensitivity to mammalian cell-derived drug products\n* known contraindications to denosumab, teriparatide, or any of their excipients\n* known contraindications to tetracycline, demeclocycline, or other antibiotics in this drug class\n* continuous use of tetracycline for \\>1-month duration within the last 10 years'}, 'identificationModule': {'nctId': 'NCT04026256', 'briefTitle': 'Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Mechanisms Underlying the Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration', 'orgStudyIdInfo': {'id': '2018P002537'}, 'secondaryIdInfos': [{'id': '5R01AR073191-04', 'link': 'https://reporter.nih.gov/quickSearch/5R01AR073191-04', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Teriparatide only', 'description': 'daily subcutaneous injection teriparatide for 3 months', 'interventionNames': ['Drug: Teriparatide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Denosumab only', 'description': 'one dose of subcutaneous injection denosumab', 'interventionNames': ['Drug: Denosumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Denosumab and teriparatide', 'description': 'daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab', 'interventionNames': ['Drug: Teriparatide', 'Drug: Denosumab']}], 'interventions': [{'name': 'Teriparatide', 'type': 'DRUG', 'otherNames': ['Forteo'], 'description': 'teriparatide daily subcutaneous injection', 'armGroupLabels': ['Denosumab and teriparatide', 'Teriparatide only']}, {'name': 'Denosumab', 'type': 'DRUG', 'otherNames': ['Prolia'], 'description': 'denosumab subcutaneous injection', 'armGroupLabels': ['Denosumab and teriparatide', 'Denosumab only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Benjamin Leder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Benjamin Leder, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}