Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-01-05 @ 4:06 AM
Study NCT ID:
NCT03174366
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2017-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069448', 'term': 'Denosumab'}], 'ancestors': [{'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': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dshofler@westernu.edu', 'phone': '9097063898', 'title': 'David Shofler', 'organization': 'Western University of Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group, Receiving Medication', 'description': 'Subjects in this group will be receiving medication (denosumab)\n\nDenosumab: Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 2, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Muscle pain, upper extremity', 'notes': 'Injection site pain, resolved after two weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'notes': 'Cellulitis of the contralateral lower extremity, resolved with oral antibiotics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group, Receiving Medication', 'description': 'Subjects in this group will be receiving medication (denosumab)\n\nDenosumab: Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.'}], 'classes': [{'categories': [{'title': 'Serious adverse event', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No serious adverse events', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Incidence of Treatment-Emergent Adverse Events \\[Safety and Tolerability\\]', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Skin Temperature Difference in Degrees Celsius Between the Affected and Non-affected Limb at 6 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group, Receiving Medication', 'description': 'Subjects in this group will be receiving medication (denosumab)\n\nDenosumab: Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.06', 'spread': '0.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change in skin temperature difference in degrees Celsius between the affected and non-affected limb at 6 months.', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group, Receiving Medication', 'description': 'Subjects in this group will be receiving medication (denosumab)\n\nDenosumab: Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group, Receiving Medication', 'description': 'Subjects in this group will be receiving medication (denosumab)\n\nDenosumab: Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.'}], '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': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '10.14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'Hispanic', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'African-American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Mixed Hispanic/Native American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-30', 'size': 436916, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-30T11:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-22', 'studyFirstSubmitDate': '2017-05-11', 'resultsFirstSubmitDate': '2019-10-01', 'studyFirstSubmitQcDate': '2017-05-30', 'lastUpdatePostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-22', 'studyFirstPostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': '1 year', 'description': 'Incidence of Treatment-Emergent Adverse Events \\[Safety and Tolerability\\]'}], 'secondaryOutcomes': [{'measure': 'Change in Skin Temperature Difference in Degrees Celsius Between the Affected and Non-affected Limb at 6 Months.', 'timeFrame': '6 months', 'description': 'Change in skin temperature difference in degrees Celsius between the affected and non-affected limb at 6 months.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Charcot Joint of Foot']}, 'descriptionModule': {'briefSummary': 'Charcot neuroarthropathy (CN) is a debilitating disease primarily affecting poorly controlled diabetic patients with peripheral neuropathy. The consequences of CN include ulcerations of the foot and ankle, osteomyelitis, and severe musculoskeletal deformity. These consequences frequently lead to below-knee amputation of the affected limb.\n\nCurrently treatment options are limited, and no pharmaceutical treatment has been efficacious in the medical literature. The purpose of this pilot study is to investigate the potential of the medication denosumab for acute stage Charcot neuroarthropathy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women \\> 30 years old\n* Subject is able and willing to comply with study procedures, and is able to give signed and dated consent\n* Subject meets criteria for diagnosis of Diabetes Mellitus Type 1 or 2, active Charcot neuroarthropathy, and peripheral neuropathy\n* Subjects with serum calcium or albumin-adjusted serum calcium ≥2.0 mmol/L (8.0mg/dL)\n\nExclusion Criteria:\n\n* Unable to provide signed and dated consent.\n* Charcot neuroarthropathy of the ipsilateral lower extremity, diagnosed over 1 month prior.\n* Prior foot or ankle surgery of the ipsilateral lower extremity.\n* Prior amputation at any level of either lower extremity.\n* Prior foot or ankle fracture of the ipsilateral lower extremity unrelated to the current acute CN episode.\n* Currently has any of the following:\n\n 1. Infection\n 2. Foot ulceration\n 3. Hypocalcemia\n 4. Creatinine clearance less than 30 mL/min or on dialysis\n 5. Pre-existing disturbance of mineral metabolism (e.g., hypoparathyroidism unstable on therapy, thyroid or parathyroid surgery, vitamin D deficiency, malabsorption syndromes, excision of small intestine, history of diseases affecting bone metabolism) that has not been effectively corrected or treated.\n* Have undergone revascularization procedures of the lower extremities.\n* Female subjects who are pregnant or planning to breastfeed should not participate in this study.\n* Determined to have poor oral hygiene after dental screening or are at increased risk for developing osteonecrosis of the jaw.\n* History of osteonecrosis of the jaw.\n* History of tooth extraction or other dental surgery within the prior 6 months.\n* Invasive dental work planned in the next 2 years.\n* Have a known hypersensitivity to Prolia.\n* Known use of a bone active medication within the 6 months prior to enrollment.\n* Liver disease, defined as AST \\> 2.0x ULN, ALT \\> 2.0x ULN, TBL \\> 1.5x ULN.\n* Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)'}, 'identificationModule': {'nctId': 'NCT03174366', 'briefTitle': 'Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy', 'organization': {'class': 'OTHER', 'fullName': 'Western University of Health Sciences'}, 'officialTitle': 'Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy', 'orgStudyIdInfo': {'id': '20159178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group, receiving medication', 'description': 'Subjects in this group will be receiving medication (denosumab)', 'interventionNames': ['Drug: Denosumab']}], 'interventions': [{'name': 'Denosumab', 'type': 'DRUG', 'description': 'Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.', 'armGroupLabels': ['Intervention Group, receiving medication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91711', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Western University of Health Sciences', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}