NCT04079868: MOPS

Models of Primary Osteoporosis Screening in Male Veterans

Completed NA Results posted Last updated 14 October 2025

What this trial tests

NA trial testing Bone Health Service Model in Osteoporosis in 3,512 participants. Completed in 31 December 2024.

Timeline

30 August 2019

Primary endpoint
31 August 2024

31 December 2024

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	screening
Enrollment	3,512
Start date	30 August 2019
Primary completion	31 August 2024
Estimated completion	31 December 2024
Sites	3 locations across United States

Drugs / interventions tested

• Bone Health Service Model

Conditions studied

• Osteoporosis — all drugs for Osteoporosis →
• Osteopenia — all drugs for Osteopenia →
• Osteoporotic Fracture — all drugs for Osteoporotic Fracture →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Eligibility, any sex, with Osteoporosis or Osteopenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Participants Screened for Osteoporosis Primary · 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

Group	Value	95% CI
Bone Health Service Arm	830
Usual Care (Control) Arm	33

Bone Mineral Density T-score at the Femoral Neck Primary · 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.

Group	Value	95% CI
Bone Health Service Arm	-0.55	± 1.28
Usual Care (Control) Arm	-0.70	± 1.25

Gastrointestinal Medication Prescriptions Secondary · through study completion, an average of 1.5 years

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

Group	Value	95% CI
Bone Health Service Arm	562
Usual Care (Control) Arm	473

Osteoporosis Medication Adherence (Proportion of Days Covered) Secondary · through study completion, an average of 1.5 years

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

Group	Value	95% CI
Bone Health Service Arm	0.92	± 0.24
Usual Care (Control) Arm	1.0	± 0.13

Proportion of Patients Initiating Osteoporosis Medication (%) Secondary · through study completion, an average of 1.5 years

Numerator is number of patients prescribed osteoporosis medications, denominator is number of patients eligible for osteoporosis medications based on their DXA results

Group	Value	95% CI
Bone Health Service Arm	113
Usual Care (Control) Arm	4

Osteoporosis Medication Persistence (Days) Secondary · through study completion, up to 2 years

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

Group	Value	95% CI
Bone Health Service Arm	657	± 366
Usual Care (Control) Arm	730	± 480

Proportion With Fractures Secondary · through study completion, an average of 1.5 years

Numerator is number of men with a confirmed fracture during study follow-up, denominator is all men eligible for osteoporosis screening at baseline

Group	Value	95% CI
Bone Health Service Arm	31
Usual Care (Control) Arm	29

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Bone Health Service Arm

Serious: 0/1688 (0%)

Deaths: 135/1688

Usual Care (Control) Arm

Serious: 0/1424 (0%)

Deaths: 89/1424

Other adverse events (1 terms — click to expand)

Reaction	System	Bone Health Service Arm	Usual Care (Control) Arm
Drug interaction	Endocrine disorders	—	—

Data from ClinicalTrials.gov NCT04079868 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Remote Bone Health Service for Osteoporosis Screening in High-Risk Men: A Cluster Randomized Clinical Trial.
   Colón-Emeric C, Lee R, Lyles KW, Zullig LL, et al · · 2025 · cited 4× · PMID 40853653 · DOI 10.1001/jamainternmed.2025.4150
2. Protocol for the models of primary osteoporosis screening in men (MOPS) cluster randomized trial.
   Colón-Emeric CS, Lee R, Pieper CF, Lyles KW, et al · · 2022 · cited 3× · PMID 34844000 · DOI 10.1016/j.cct.2021.106634