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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.
Background/Purpose:
Osteoporosis 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.
Fractures 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.
Osteoporosis 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.
Attempts 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.
Objectives:
The 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.
Outcomes 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).
Patient-level outcomes:
Provider and facility level outcomes:
Health system and policy level outcomes
Methodology:
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone Health Service arm | Experimental | Interventional arm |
|
| Usual care (control) arm | No Intervention | This arm represents a "no practice management support" control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Health Service Model | Behavioral | Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Screened for Osteoporosis | 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 | through study completion, an average of 1.5 years |
| Bone Mineral Density T-score at the Femoral Neck | 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. | 2 years after the primary care team's start date |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Medication Prescriptions | 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 | through study completion, an average of 1.5 years |
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Inclusion Criteria:
PACT Team inclusion criteria:
Patient Inclusion criteria:
Patients (enrolled in year 4/5 sub-sample) inclusion criteria:
Exclusion Criteria:
None
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| Name | Affiliation | Role |
|---|---|---|
| Cathleen S Colon-Emeric, MD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705-3875 | United States | ||
| VA Salt Lake City Health Care System, Salt Lake City, UT |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40853653 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bone Health Service Arm | Interventional arm Bone 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. |
| FG001 | Usual Care (Control) Arm | This arm represents a "no practice management support" control group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bone Health Service Arm | Interventional arm Bone 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. |
| BG001 | Usual Care (Control) Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Screened for Osteoporosis | 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 | Posted | Number | participants | through study completion, an average of 1.5 years |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bone Health Service Arm | Interventional arm Bone 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug interaction | Endocrine disorders | Systematic Assessment | Interaction between calcium supplements prescribed in BHS patient with prescribed levothyroxine with asymptomatic TSH elevation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cathleen Colon-Emeric | Durham VA Geriatric Research Education and Clinical Center | 9192860411 | 6932 | cathleen.colon-emeric@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 21, 2020 | Jun 23, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2018 | Jun 23, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2023 | Sep 30, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D058866 | Osteoporotic Fractures |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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Outcome assessors will be masked to the group assignment
| Osteoporosis Medication Adherence (Proportion of Days Covered) |
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 |
| through study completion, an average of 1.5 years |
| Proportion of Patients Initiating Osteoporosis Medication (%) | Numerator is number of patients prescribed osteoporosis medications, denominator is number of patients eligible for osteoporosis medications based on their DXA results | through study completion, an average of 1.5 years |
| Osteoporosis Medication Persistence (Days) | 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 | through study completion, up to 2 years |
| Proportion With Fractures | Numerator is number of men with a confirmed fracture during study follow-up, denominator is all men eligible for osteoporosis screening at baseline | through study completion, an average of 1.5 years |
| Salt Lake City |
| Utah |
| 84148-0001 |
| United States |
| Hunter Holmes McGuire VA Medical Center, Richmond, VA | Richmond | Virginia | 23249-0001 | United States |
This arm represents a "no practice management support" control group. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Bone Mineral Density T-score at the Femoral Neck | 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. | Posted | Mean | Standard Deviation | T score femoral neck | 2 years after the primary care team's start date |
|
|
|
| Secondary | Gastrointestinal Medication Prescriptions | 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 | Posted | Count of Participants | Participants | through study completion, an average of 1.5 years |
|
|
|
| Secondary | Osteoporosis Medication Adherence (Proportion of Days Covered) | 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 | Posted | Mean | Standard Deviation | proportion of days covered by meds | through study completion, an average of 1.5 years |
|
|
|
| Secondary | Proportion of Patients Initiating Osteoporosis Medication (%) | Numerator is number of patients prescribed osteoporosis medications, denominator is number of patients eligible for osteoporosis medications based on their DXA results | Posted | Count of Participants | Participants | through study completion, an average of 1.5 years |
|
|
|
| Secondary | Osteoporosis Medication Persistence (Days) | 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 | Posted | Mean | Standard Deviation | days | through study completion, up to 2 years |
|
|
|
| Secondary | Proportion With Fractures | Numerator is number of men with a confirmed fracture during study follow-up, denominator is all men eligible for osteoporosis screening at baseline | Posted | Count of Participants | Participants | through study completion, an average of 1.5 years |
|
|
|
| 135 |
| 1,688 |
| 0 |
| 1,688 |
| 1 |
| 1,688 |
| EG001 | Usual Care (Control) Arm | This arm represents a "no practice management support" control group. | 89 | 1,424 | 0 | 1,424 | 0 | 1,424 |
|
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| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |