Models of Primary Osteoporosis Screening in Male Veterans (MOPS)

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Osteopenia; Osteoporotic Fracture
• Intervention / Treatment: Behavioral: Bone Health Service Model

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 Type: Interventional
• Enrollment (Actual): 3512
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705-3875
      • Durham VA Medical Center, Durham, NC
  • Utah
    • Salt Lake City, Utah, United States, 84148-0001
      • VA Salt Lake City Health Care System, Salt Lake City, UT
  • Virginia
    • Richmond, Virginia, United States, 23249-0001
      • Hunter Holmes McGuire VA Medical Center, Richmond, VA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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
• 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.

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bone Health Service arm; Interventional arm	Behavioral: 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.
No Intervention: Usual care (control) arm; This arm represents a "no practice management support" control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Cathleen S Colon-Emeric, MD, Durham VA Medical Center, Durham, NC

Publications and helpful links

General 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 Aug 25:e254150. doi: 10.1001/jamainternmed.2025.4150. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2019
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Osteoporosis; Osteopenia; Osteoporotic fracture; Age-Related Osteoporosis; Bone Loss, Age-Related
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Metabolic Diseases; Fractures, Bone; Nutritional and Metabolic Diseases; Osteoporosis; Osteoporotic Fractures; Bone Diseases, Metabolic
• Other Study ID Numbers: IIR 17-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No