OsteoporosisMOPSNCT04079868
Models of Primary Osteoporosis Screening in Male Veterans
A study testing Bone Health Service Model in people with Osteoporosis and Osteopenia, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoporosis, Osteopenia, Osteoporotic Fracture
- What is being tested?
- Bone Health Service Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,512 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Aug 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PACT Team inclusion criteria:
- Provider with at least 0.75 FTE
- Provider has completed training (i.e., PACT teams led by residents and fellows are excluded)
- Care for male Veterans >65 years (i.e., Women's Health PACTs are excluded)
- Patient Inclusion criteria:
- No prior fracture or osteoporosis diagnosis
Show all 11Show fewer
- 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).
- Patients (enrolled in year 4/5 sub-sample) inclusion criteria:
- Men aged 65-85 years
- Enrolled in eligible PACT team for at least 2 years
- Meet 1 or more criteria for osteoporosis screening as the protocol at PACT enrollment.
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
About this study
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.
Read the detailed description
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:
- Eligible proportion screened
- Medication adherence
- PACT fracture rates
- Harms
- Bone mineral density
Provider and facility level outcomes:
- Change in Dual-energy X-ray absorptiometry (DXA) volume
- Bone mineral density (sub-sample of patients)
- Change in metabolic bone disease clinic volume
- PACT provider time and satisfaction (qualitative analyses)
Health system and policy level outcomes
- Program cost effectiveness
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.
- Conditions
- Osteoporosis, Osteopenia, Osteoporotic Fracture
- Being tested
- Bone Health Service Model
- Keywords
- Osteoporosis, Osteopenia, Osteoporotic fracture, Age-Related Osteoporosis, Bone Loss, Age-Related
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Health Service ModelBehavioural
Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.
| Study group | Role | What they receive |
|---|---|---|
| Bone Health Service arm | Experimental | Interventional arm Receives: Behavioral: Bone Health Service Model |
| Usual care (control) arm | No intervention | This arm represents a "no practice management support" control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 2 years after the primary care team's start date
Secondary outcomes (5)
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
Measured: through study completion, an average of 1.5 years
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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start30 Aug 2019
- Primary completion31 Aug 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,512 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Cathleen S Colon-Emeric, MD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079868
- Sponsor's protocol ID
- IIR 17-202
- Acronym
- MOPS
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2019
- Last updated
- 14 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40853653
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Models of Primary Osteoporosis Screening in Male Veterans
- ClinicalTrials.gov ID
- NCT04079868
- Acronym / sponsor ID
- MOPS / IIR 17-202
- Conditions
- Osteoporosis, Osteopenia, Osteoporotic Fracture
- Keywords
- Osteoporosis, Osteopenia, Osteoporotic fracture, Age-Related Osteoporosis, Bone Loss, Age-Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,512 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Posted 14 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Eligible proportion screened
- Medication adherence
- PACT fracture rates
- Harms
- Bone mineral density
Provider and facility level outcomes:
- Change in Dual-energy X-ray absorptiometry (DXA) volume
- Bone mineral density (sub-sample of patients)
- Change in metabolic bone disease clinic volume
- PACT provider time and satisfaction (qualitative analyses)
Health system and policy level outcomes
- Program cost effectiveness
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bone Health Service arm | Experimental | Behavioral: Bone Health Service ModelInterventional arm |
| Usual care (control) arm | No intervention | –This arm represents a "no practice management support" control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Provider with at least 0.75 FTE
- Provider has completed training (i.e., PACT teams led by residents and fellows are excluded)
- Care for male Veterans >65 years (i.e., Women's Health PACTs are excluded)
- No prior fracture or osteoporosis diagnosis
- 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).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Health Service ModelPatients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team. | Behavioural | Bone Health Service arm |
Primary outcome
Proportion of Participants Screened for Osteoporosis
Time frame: through study completion, an average of 1.5 years
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
Bone Mineral Density T-score at the Femoral Neck
Time frame: 2 years after the primary care team's start date
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.
5 secondary outcomes
Gastrointestinal Medication Prescriptions
Time frame: through study completion, an average of 1.5 years
Osteoporosis Medication Adherence (Proportion of Days Covered)
Time frame: through study completion, an average of 1.5 years
Proportion of Patients Initiating Osteoporosis Medication (%)
Time frame: through study completion, an average of 1.5 years
Osteoporosis Medication Persistence (Days)
Time frame: through study completion, up to 2 years
Proportion With Fractures
Time frame: through study completion, an average of 1.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40853653Colon-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathleen S Colon-Emeric, MD principal investigator
Durham VA Medical Center, Durham, NC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Health Service Model in people with Osteoporosis and Osteopenia, run by VA Office of Research and Development at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Screened for Osteoporosis (time frame: through study completion, an average of 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04079868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.