Screening Models for Osteoporosis in Male Veterans

(MOPS Trial)

No longer recruiting at 2 trial locations

Overseen By Robert A Adler, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Fracture, Osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to screen for and treat osteoporosis in male veterans using a special Bone Health Service Model, a comprehensive care approach. The goal is to evaluate the model's effectiveness compared to usual care, focusing on outcomes for patients and healthcare providers. Veterans who may qualify for this trial are men without previous fractures or osteoporosis but with risk factors such as significant weight loss, diabetes, or chronic conditions like liver or lung disease. As an unphased trial, this study provides veterans the chance to contribute to innovative healthcare solutions and potentially enhance their bone health management.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this care model is safe for osteoporosis screening in male veterans?

Research has shown that the Bone Health Service Model for assessing bone health is generally easy for patients to manage. In a study involving 157 patients using this model, 84.4% began and continued treatment for osteoporosis, indicating that most patients handled the process without major issues.

Overall, the Bone Health Service Model appears to reduce the risk of fractures and is recommended for broader use by the National Bone Health Alliance. Although the study did not list specific side effects, the high adherence rate suggests the treatment is manageable for most people.

For those considering joining a trial using this model, these findings suggest it is likely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bone Health Service Model for osteoporosis in male veterans because it offers a new way to manage bone health through a structured service model, rather than relying solely on medications like bisphosphonates or hormone therapies. This approach is unique because it focuses on comprehensive care, potentially including lifestyle modifications, dietary guidance, exercise programs, and regular monitoring, which are tailored specifically for male veterans. The goal is to improve bone health outcomes by providing personalized support and education, which could lead to better adherence to treatment plans and overall bone health.

What evidence suggests that the Bone Health Service Model is effective for osteoporosis screening in male veterans?

Studies have shown that new methods for checking osteoporosis can greatly reduce the risk of broken bones. Specifically, these methods have lowered fracture rates by 56% over two years compared to regular care. The National Bone Health Alliance endorses these new screening methods due to their effectiveness. They help detect osteoporosis early and make treatment more affordable. This trial will compare the Bone Health Service Model, tested in the experimental arm, to usual care in male veterans. This evidence suggests that the Bone Health Service Model could effectively reduce fractures in high-risk male veterans. ^{2 3 6 7 8}

Who Is on the Research Team?

Cathleen S Colon-Emeric, MD

Principal Investigator

Durham VA Medical Center, Durham, NC

Are You a Good Fit for This Trial?

This trial is for male veterans aged 65-85 who have not been diagnosed with osteoporosis or had a fracture, are part of a PACT team led by a provider with at least 0.75 FTE and training, have been enrolled in an eligible PACT team for over two years, and meet one or more VA risk factors for osteoporosis.

Inclusion Criteria

I am a male Veteran over 65 receiving care.

PACT Team inclusion criteria: Provider with at least 0.75 FTE

Patients enrolled in years 4 or 5 need to meet at least one criterion for osteoporosis screening as outlined in the PACT enrollment protocol.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

12 months

1 visit (in-person)

Intervention

Randomized PACT teams are assigned to either the Bone Health Service model or usual care, with screening and treatment of high-risk male Veterans

2 years

Regular visits as per PACT team schedule

Follow-up

Participants are monitored for outcomes such as medication adherence, fracture rates, and bone mineral density

4 years

Annual assessments

Qualitative Assessment

Sub-set of providers and patients participate in qualitative interviews and DXA scans

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Bone Health Service Model

Trial Overview The study is testing the effectiveness of a primary osteoporosis screening care model within the VA healthcare system. It will evaluate outcomes related to patients, providers, and facilities to determine how well each intervention works.

How Is the Trial Designed?

Group I: Bone Health Service arm Experimental Treatment 1 Intervention

Interventional arm

Group II: Usual care (control) arm Active Control 1 Intervention

This arm represents a "no practice management support" control group.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9234902/

Protocol for the Models of Primary Osteoporosis Screening ... The overall objective of this study is to determine whether a new model of primary osteoporosis screening reduces fracture risk compared to usual care. We are ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421003700

Protocol for the models of primary osteoporosis screening ... Such models have reduced 2-year fracture rates by 56% [22] and are highly cost-effective [23,24]. The National Bone Health Alliance recommends expansion of BHS ...

3. hsrd.research.va.gov hsrd.research.va.gov/research/abstracts.cfm?Project_ID=2141707042

IIR 17-202 – HSR Study - VA Health Systems Research Expected results are the relative effectiveness and cost-effectiveness of 2 new models of osteoporosis screening and adherence promotion. Next steps include ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04079868

Models of Primary Osteoporosis Screening in Male Veterans Outcomes for all patients eligible for osteoporosis screening within the randomized PACTs will be assessed by investigators masked to group assignment. Outcomes ...

5. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/document/final-evidence-summary/osteoporosis-screening

Evidence Summary: Osteoporosis to Prevent Fractures Results: Three RCTs and 3 systematic reviews reported benefits of screening in older, higher-risk women. Two RCTs used 2-stage screening: ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40853653/

Remote Bone Health Service for Osteoporosis Screening ... One hundred fifty-seven patients (84.4%) in the BHS group initiated osteoporosis treatment and achieved high levels of adherence with a mean of ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2829239

Screening for Osteoporosis to Prevent Fractures: A ... Screening in higher-risk women 65 years or older was associated with a small absolute risk reduction in hip and major fractures compared with ...

8. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/osteoporosis-screening

Osteoporosis to Prevent Fractures: Screening In 2023, the Canadian Task Force on Preventive Health Care recommended screening women 65 years or older for fracture risk with the Canadian ...