Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT01875458
Status:
COMPLETED
Last Update Posted:
2023-01-13
First Post:
2013-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarker Identification in Orthopaedic & Oral Maxillofacial Surgery Subjects to Identify Risks of Bisphosphonate Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D059266', 'term': 'Bisphosphonate-Associated Osteonecrosis of the Jaw'}], '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'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva has been collected from participants and DNA analysis will be performed. Blood and tissue samples has been collected from in-person participants. DNA and RNA analysis will be performed.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 314}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2013-06-07', 'studyFirstSubmitQcDate': '2013-06-07', 'lastUpdatePostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absorption, Distribution, Metabolism, Excretion (ADME) Profiling of DNA from all sample types vs. normative data for the ADME panel and across study groups', 'timeFrame': 'Baseline', 'description': 'DNA analysis of saliva, blood, and tissues to detect differential response to drugs. DNA will be isolated from each sample and ADME profiling will be performed. Each participant subgroup will be compared to each other using ANOVA modeling. Each participant subgroup will be compared to normative data for the distribution of gene profiles in the general population for each probe on the ADME gene array.'}], 'secondaryOutcomes': [{'measure': 'Differential expression of miRNA biomarkers across participant groups within the study', 'timeFrame': 'Baseline', 'description': 'The relative abundance of miRNA across each participant subgroup will be compared using ANOVA modeling. Each participant subgroup will be compared to normative data for the distribution of miRNA expression profiles in the general population for each probe when available.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aclasta', 'Actonel', 'alendronate', 'alendronate/cholecalciferol', 'Aredia', 'Atelvia', 'Boniva', 'Didronel', 'etidronate', 'Fosamax', 'Fosamax Plus D', 'ibandronate', 'pamidronate', 'Reclast', 'risedronate', 'Skelid', 'tiludronate', 'zoledronic acid', 'Zometa', 'Bisphosphonate', 'Atypical Femur Fracture (AFF)', 'Osteoporosis', 'Bisphosphonate Related Osteonecrosis of the Jaw (BRONJ)'], 'conditions': ['Osteoporosis, With or Without Treatment', 'Bisphosphonate Treatment', 'Atypical Femur Fracture', 'Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ)', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Bisphosphonates are drugs that prevent bone loss by blocking the activity of cells that normally resorb bone. The most common examples of these drugs are Boniva and Fosamax. These drugs are available for oral or intravenous dosing and are prescribed at daily, weekly, biweekly, or monthly intervals. Among the many thousands of individuals who currently take these medications, certain individuals experience "atypical" femur fractures preceded by prodromal pain, changes in cortical thickening of bone, or bisphosphonate related osteonecrosis of the jaws (BRONJ). Osteonecrosis of the jaws is defined as exposed bone of the jaws for 8 weeks or more and requires surgical treatment.\n\nThis study will attempt to identify genomic and rna biomarkers that may play a role in differential metabolism of bisphosphonates or indicate tendency toward the severe adverse events associated with these drugs.', 'detailedDescription': 'Collected specimens were subjected to Affymetrix DMET™ Plus Solution analysis. Manuscript is in preparation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults who either have ever taken bisphosphonates (see list under Key Words) and/or who have ever had an atypical femur fracture or bisphosphonate related osteonecrosis of the jaws (BRONJ) or both. Also healthy volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any adult (male or female) age 18 or over meeting any of the following criteria:\n* All participants must be able to provide informed consent for themselves.\n* History of BP treatment with or without BRONJ and/or Femur fracture (typical or atypical)\n* No History of BP treatment with or without BRONJ and/or Femur fracture (typical or atypical)\n\nExclusion Criteria:\n\n* Children age 17 or younger\n* Adults who cannot or do not make medical decisions for themselves\n* Persons known to be under the jurisdiction of the Department of Corrections\n* Individuals who are pregnant.'}, 'identificationModule': {'nctId': 'NCT01875458', 'briefTitle': 'Biomarker Identification in Orthopaedic & Oral Maxillofacial Surgery Subjects to Identify Risks of Bisphosphonate Use', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Biomarker Identification in Orthopaedic and Oral Maxillofacial Subjects', 'orgStudyIdInfo': {'id': '815570'}, 'secondaryIdInfos': [{'id': '815570', 'type': 'OTHER', 'domain': 'UPenn IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'CASES', 'description': 'Adults with current or past history of bisphosphonate treatment (exposed) with Bisphosphonate related Osteonecrosis of the Jaws (BRONJ), or, Adults with current or past history of bisphosphonate treatment (exposed) with atypical fracture'}, {'label': 'COUNTER MATCHED CONTROLS', 'description': 'Adults with current or past history of bisphosphonate treatment (exposed) without bisphosphonate related osteonecrosis of the jaws (BRONJ, or, Adults with current or past history of bisphosphonate treatment (exposed) with typical fracture or joint replacement or osteoporosis'}, {'label': 'MATCHED CONTROLS', 'description': 'Adults without current bisphosphonate treatment (unexposed) with Typical fracture (healthy fracture patients) Adults without current bisphosphonate treatment (unexposed) without BRONJ (healthy oral surgery subjects or adults with radionecrosis of the jaws)'}, {'label': 'Healthy Adult Volunteers', 'description': 'Healthy volunteers with or without current bisphosphonate treatment without jaw or extremity pathologies or injuries to contribute blood and saliva samples only.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Samir Mehta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania, Department of Orthopaedic Surgery'}, {'name': 'Annamarie D Horan, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The results of this study will be shared in the form of a published article if accepted. Currently, the manuscript is in draft form and pending submission.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}