Screening Models for Osteoporosis in Male Veterans

(MOPS Trial)

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

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

Compensation: Varies

Number of Visits: 1

39 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Cathleen S Colon-Emeric, MD

Principal Investigator

Durham VA Medical Center, Durham, NC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+