Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-28 @ 8:32 PM
Study NCT ID:
NCT04079868
Status:
COMPLETED
Last Update Posted:
2025-10-14
First Post:
2019-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Models of Primary Osteoporosis Screening in Male Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D058866', 'term': 'Osteoporotic Fractures'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cathleen.colon-emeric@va.gov', 'phone': '9192860411', 'title': 'Dr. Cathleen Colon-Emeric', 'phoneExt': '6932', 'organization': 'Durham VA Geriatric Research Education and Clinical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Bone Health Service Arm', 'description': 'Interventional arm\n\nBone Health Service Model: Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.', 'otherNumAtRisk': 1688, 'deathsNumAtRisk': 1688, 'otherNumAffected': 1, 'seriousNumAtRisk': 1688, 'deathsNumAffected': 135, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care (Control) Arm', 'description': 'This arm represents a "no practice management support" control group.', 'otherNumAtRisk': 1424, 'deathsNumAtRisk': 1424, 'otherNumAffected': 0, 'seriousNumAtRisk': 1424, 'deathsNumAffected': 89, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Drug interaction', 'notes': 'Interaction between calcium supplements prescribed in BHS patient with prescribed levothyroxine with asymptomatic TSH elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1688, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1424, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants Screened for Osteoporosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1688', 'groupId': 'OG000'}, {'value': '1424', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone Health Service Arm', 'description': 'Interventional arm\n\nBone Health Service Model: Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.'}, {'id': 'OG001', 'title': 'Usual Care (Control) Arm', 'description': 'This arm represents a "no practice management support" control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '830', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'Proportion of men who received DXA screening for for osteoporosis. Numerator is the number of men with a completed screening DXA, denominator is all patients meeting current osteoporosis screening criteria', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Bone Mineral Density T-score at the Femoral Neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone Health Service Arm', 'description': 'Interventional arm\n\nBone Health Service Model: Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.'}, {'id': 'OG001', 'title': 'Usual Care (Control) Arm', 'description': 'This arm represents a "no practice management support" control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.55', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '1.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': "2 years after the primary care team's start date", 'description': 'Bone mineral density in gm/cm2 as measured by DXA, converted to T-score by the densitometer manufacturer. The T score reflects the number of standard deviations away from the mean bone density of young healthy women as defined in the National Health and Nutrition Survey. Lower T-scores reflect worse bone density, and T-scores \\<= -1 are consistent with osteopenia or osteoporosis. This outcome was measured in a random subset of enrolled patients (target n=25 per primary care team), regardless of whether or not they had undergone osteoporosis screening during the study period.', 'unitOfMeasure': 'T score femoral neck', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Medication Prescriptions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1688', 'groupId': 'OG000'}, {'value': '1424', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone Health Service Arm', 'description': 'Interventional arm\n\nBone Health Service Model: Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.'}, {'id': 'OG001', 'title': 'Usual Care (Control) Arm', 'description': 'This arm represents a "no practice management support" control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '562', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'This is a measure of potential harm from osteoporosis treatment. Numerator is number of men with new prescription for proton pump inhibitor or H2 blocker, denominator is all men eligible for osteoporosis screening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Osteoporosis Medication Adherence (Proportion of Days Covered)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone Health Service Arm', 'description': 'Interventional arm\n\nBone Health Service Model: Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.'}, {'id': 'OG001', 'title': 'Usual Care (Control) Arm', 'description': 'This arm represents a "no practice management support" control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'For patients started on osteoporosis medications, numerator is the total number of dispensed units, denominator is the number of days between the first medication prescription and medication discontinuation, death, or end of the study period', 'unitOfMeasure': 'proportion of days covered by meds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Initiating Osteoporosis Medication (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone Health Service Arm', 'description': 'Interventional arm\n\nBone Health Service Model: Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.'}, {'id': 'OG001', 'title': 'Usual Care (Control) Arm', 'description': 'This arm represents a "no practice management support" control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'Numerator is number of patients prescribed osteoporosis medications, denominator is number of patients eligible for osteoporosis medications based on their DXA results', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Osteoporosis Medication Persistence (Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone Health Service Arm', 'description': 'Interventional arm\n\nBone Health Service Model: Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.'}, {'id': 'OG001', 'title': 'Usual Care (Control) Arm', 'description': 'This arm represents a "no practice management support" control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '657', 'spread': '366', 'groupId': 'OG000'}, {'value': '730', 'spread': '480', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, up to 2 years', 'description': 'Among participants who were prescribed an osteoporosis medication, the mean number of days between the first dispensing date until a gap in medication prescription of \\>=90 days occurred', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion With Fractures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1688', 'groupId': 'OG000'}, {'value': '1424', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bone Health Service Arm', 'description': 'Interventional arm\n\nBone Health Service Model: Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.'}, {'id': 'OG001', 'title': 'Usual Care (Control) Arm', 'description': 'This arm represents a "no practice management support" control group.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'Numerator is number of men with a confirmed fracture during study follow-up, denominator is all men eligible for osteoporosis screening at baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bone Health Service Arm', 'description': 'Interventional arm\n\nBone Health Service Model: Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.'}, {'id': 'FG001', 'title': 'Usual Care (Control) Arm', 'description': 'This arm represents a "no practice management support" control group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '20', 'numSubjects': '1888'}, {'groupId': 'FG001', 'numUnits': '19', 'numSubjects': '1624'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '18', 'numSubjects': '1688'}, {'groupId': 'FG001', 'numUnits': '17', 'numSubjects': '1424'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '200'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '200'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Primary care teams'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1688', 'groupId': 'BG000'}, {'value': '1424', 'groupId': 'BG001'}, {'value': '3112', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bone Health Service Arm', 'description': 'Interventional arm\n\nBone Health Service Model: Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.'}, {'id': 'BG001', 'title': 'Usual Care (Control) Arm', 'description': 'This arm represents a "no practice management support" control group.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.0', 'spread': '5.2', 'groupId': 'BG000'}, {'value': '73.8', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '73.4', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1688', 'groupId': 'BG000'}, {'value': '1424', 'groupId': 'BG001'}, {'value': '3112', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '695', 'groupId': 'BG000'}, {'value': '565', 'groupId': 'BG001'}, {'value': '1260', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '930', 'groupId': 'BG000'}, {'value': '818', 'groupId': 'BG001'}, {'value': '1748', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-21', 'size': 622385, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-23T16:15', 'hasProtocol': True}, {'date': '2018-11-06', 'size': 1141616, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-23T16:19', 'hasProtocol': False}, {'date': '2023-03-28', 'size': 238724, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-09-30T11:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors will be masked to the group assignment'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Stratified, block randomization will be used. A statistician unaware of team identity will randomize PACTs in blocks of 2 within strata to ensure similar distributions. If insufficient numbers of PACTs are recruited within small CBOCs, they will be combined with other similar CBOCs (rural vs. urban) for randomization.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3512}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2019-08-28', 'resultsFirstSubmitDate': '2025-07-03', 'studyFirstSubmitQcDate': '2019-09-04', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-25', 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants Screened for Osteoporosis', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'Proportion of men who received DXA screening for for osteoporosis. Numerator is the number of men with a completed screening DXA, denominator is all patients meeting current osteoporosis screening criteria'}, {'measure': 'Bone Mineral Density T-score at the Femoral Neck', 'timeFrame': "2 years after the primary care team's start date", 'description': 'Bone mineral density in gm/cm2 as measured by DXA, converted to T-score by the densitometer manufacturer. The T score reflects the number of standard deviations away from the mean bone density of young healthy women as defined in the National Health and Nutrition Survey. Lower T-scores reflect worse bone density, and T-scores \\<= -1 are consistent with osteopenia or osteoporosis. This outcome was measured in a random subset of enrolled patients (target n=25 per primary care team), regardless of whether or not they had undergone osteoporosis screening during the study period.'}], 'secondaryOutcomes': [{'measure': 'Gastrointestinal Medication Prescriptions', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'This is a measure of potential harm from osteoporosis treatment. Numerator is number of men with new prescription for proton pump inhibitor or H2 blocker, denominator is all men eligible for osteoporosis screening'}, {'measure': 'Osteoporosis Medication Adherence (Proportion of Days Covered)', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'For patients started on osteoporosis medications, numerator is the total number of dispensed units, denominator is the number of days between the first medication prescription and medication discontinuation, death, or end of the study period'}, {'measure': 'Proportion of Patients Initiating Osteoporosis Medication (%)', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'Numerator is number of patients prescribed osteoporosis medications, denominator is number of patients eligible for osteoporosis medications based on their DXA results'}, {'measure': 'Osteoporosis Medication Persistence (Days)', 'timeFrame': 'through study completion, up to 2 years', 'description': 'Among participants who were prescribed an osteoporosis medication, the mean number of days between the first dispensing date until a gap in medication prescription of \\>=90 days occurred'}, {'measure': 'Proportion With Fractures', 'timeFrame': 'through study completion, an average of 1.5 years', 'description': 'Numerator is number of men with a confirmed fracture during study follow-up, denominator is all men eligible for osteoporosis screening at baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Osteopenia', 'Osteoporotic fracture', 'Age-Related Osteoporosis', 'Bone Loss, Age-Related'], 'conditions': ['Osteoporosis', 'Osteopenia', 'Osteoporotic Fracture']}, 'referencesModule': {'references': [{'pmid': '40853653', 'type': 'DERIVED', 'citation': 'Colon-Emeric C, Lee R, Lyles KW, Zullig LL, Sloane R, Pieper CF, Nelson RE, Adler RA. Remote Bone Health Service for Osteoporosis Screening in High-Risk Men: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2025 Oct 1;185(10):1218-1224. doi: 10.1001/jamainternmed.2025.4150.'}]}, 'descriptionModule': {'briefSummary': 'Models of Osteoporosis Screening in Male Veterans aims to test 1 distinct care model of primary osteoporosis screening in men within the VA healthcare setting. All care models deliver VA recommended osteoporosis screening and treatment to high-risk Veterans by appropriate Durham VA clinical staff. The MOPS project will evaluate patient, provider and facility outcomes to determine the effectiveness of each intervention.', 'detailedDescription': 'Background/Purpose:\n\nOsteoporosis is under-recognized in older men. At age 50 years, 1 in 5 men can expect to suffer a major osteoporotic fracture in their remaining lifetime, comparable to the risk of prostate cancer. Men are more than twice as likely as women to experience complications after a fracture, and have greater excess mortality after hip fracture. Because risk factors are common in Veterans, osteoporosis is particularly prevalent in the Veterans Health Administration (VA) system. More than half of male Veterans over age 50 years have osteopenia or osteoporosis, a rate nearly double the non-Veteran population.\n\nFractures resulting from osteoporosis have negative consequences on functional status, mortality, and quality of life, with high rates of pain, depression, and loss of independence. After a hip fracture, nearly 75% of patients spend time in a nursing facility, and only 20% regain their prior level of ambulation. Many fractures are associated with substantial excess mortality; men with a hip fracture have excess annual mortality of 20% that persists up to 10 years. Osteoporotic fractures also have an important economic impact. It is estimated that hip fractures result in 43 million dollars of excess cost to the VHA annually.\n\nOsteoporosis screening and treatment services within VA are ineffective overall. Overall, screening rates were 8% for men over age 65; far lower than expected based on the prevalence of osteoporosis risk factors in the population. Moreover, even among men in whom screening was completed, it was not associated with lower overall fracture rates because osteoporosis treatment and adherence following screening were extremely low.\n\nAttempts to improve osteoporosis screening using traditional quality improvement programs have been minimally effective. Electronic health record (EHR) alerts alone do not improve osteoporosis screening rates and do nothing to address adherence. However, one distinct osteoporosis screening paradigm has been suggested, and form the scientific premise for the models proposed in this application. A fracture Liaison Service (referred to here as "Bone Health Service", BHS) represents a centralized model that has been successful in improving secondary osteoporosis screening and treatment adherence after a fracture has already occurred. In this model, a team of nurses led by a bone specialist identify patients with fracture within the entire health system, and arrange for evaluation and treatment. Such models have reduced 2-year fracture rates by 56% and are cost saving or highly cost-effective.\n\nObjectives:\n\nThe investigators propose a pragmatic group randomized trial of PACT teams from both Durham and Richmond VAMC\'s. A PACT\'s will be randomized into 2 groups: a control group (no additional support), and a centralized Bone Health Service (BHS) model where teams will manage the screening and treatment of high-risk for fracture male Veterans.\n\nOutcomes for all patients eligible for osteoporosis screening within the randomized PACTs will be assessed by investigators masked to group assignment. Outcomes for PACT providers will be assessed using qualitative methods (nominal group technique).\n\nPatient-level outcomes:\n\n* Eligible proportion screened\n* Medication adherence\n* PACT fracture rates\n* Harms\n* Bone mineral density\n\nProvider and facility level outcomes:\n\n* Change in Dual-energy X-ray absorptiometry (DXA) volume\n* Bone mineral density (sub-sample of patients)\n* Change in metabolic bone disease clinic volume\n* PACT provider time and satisfaction (qualitative analyses)\n\nHealth system and policy level outcomes\n\n* Program cost effectiveness\n\nMethodology:\n\nThe investigators will compare the 1 screening models by enrolling, screening and randomizing PACT teams. 39 teams will be randomized, an estimated 24 teams at the Durham VA health care system and 15 at the Richmond VA medical center. Teams will be randomized to 1 of 2 arms: Bone Health Service or usual care (no additional support). A sub-set of providers will be recruited to complete a nominal group qualitative interview during year 3. Also a random sub-set of patients (900) will be recruited to complete a DXA scan to measure bone density beginning in year 4. Outcomes will be assessed at year 1, 2, 3, and 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPACT Team inclusion criteria:\n\n* Provider with at least 0.75 FTE\n* Provider has completed training (i.e., PACT teams led by residents and fellows are excluded)\n* Care for male Veterans \\>65 years (i.e., Women's Health PACTs are excluded)\n\nPatient Inclusion criteria:\n\n* No prior fracture or osteoporosis diagnosis\n* At least 1 VA Undersecretary Guideline risk factor (weight loss \\>20% in 5 years; BMI \\<25 kg/m2; diabetes; pernicious anemia; gastrectomy; anticonvulsants; glucocorticoids; androgen deprivation therapy; hyperthyroidism; hyperparathyroidism; rheumatoid arthritis; alcohol dependence; chronic lung disease; chronic liver disease; stroke; Parkinsonism; prostate cancer; and current smoking).\n\nPatients (enrolled in year 4/5 sub-sample) inclusion criteria:\n\n* Men aged 65-85 years\n* Enrolled in eligible PACT team for at least 2 years\n* Meet 1 or more criteria for osteoporosis screening as the protocol at PACT enrollment.\n\nExclusion Criteria:\n\nNone"}, 'identificationModule': {'nctId': 'NCT04079868', 'acronym': 'MOPS', 'briefTitle': 'Models of Primary Osteoporosis Screening in Male Veterans', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Models of Primary Osteoporosis Screening in Male Veterans', 'orgStudyIdInfo': {'id': 'IIR 17-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bone Health Service arm', 'description': 'Interventional arm', 'interventionNames': ['Behavioral: Bone Health Service Model']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care (control) arm', 'description': 'This arm represents a "no practice management support" control group.'}], 'interventions': [{'name': 'Bone Health Service Model', 'type': 'BEHAVIORAL', 'description': 'Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.', 'armGroupLabels': ['Bone Health Service arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705-3875', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA Medical Center, Durham, NC', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '84148-0001', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'VA Salt Lake City Health Care System, Salt Lake City, UT', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23249-0001', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hunter Holmes McGuire VA Medical Center, Richmond, VA', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Cathleen S Colon-Emeric, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Durham VA Medical Center, Durham, NC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}