Trial Outcomes & Findings for Models of Primary Osteoporosis Screening in Male Veterans (NCT NCT04079868)

NCT ID: NCT04079868

Last Updated: 2025-10-14

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3512 participants
• Primary outcome timeframe: through study completion, an average of 1.5 years
• Results posted on: 2025-10-14

Participant Flow

Unit of analysis: Primary care teams

Participant milestones

Measure	Bone Health Service Arm Interventional arm 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.	Usual Care (Control) Arm This arm represents a "no practice management support" control group.
Overall Study STARTED	1888 20	1624 19
Overall Study COMPLETED	1688 18	1424 17
Overall Study NOT COMPLETED	200 2	200 2

Reasons for withdrawal

Measure	Bone Health Service Arm Interventional arm 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.	Usual Care (Control) Arm This arm represents a "no practice management support" control group.
Overall Study Lost to Follow-up	100	200
Overall Study Physician Decision	100	0

Baseline Characteristics

Models of Primary Osteoporosis Screening in Male Veterans

Baseline characteristics by cohort

Measure	Bone Health Service Arm n=1688 Participants Interventional arm 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.	Usual Care (Control) Arm n=1424 Participants This arm represents a "no practice management support" control group.	Total n=3112 Participants Total of all reporting groups
Age, Continuous	73.0 years STANDARD_DEVIATION 5.2 • n=5 Participants	73.8 years STANDARD_DEVIATION 5.4 • n=7 Participants	73.4 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1688 Participants n=5 Participants	1424 Participants n=7 Participants	3112 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	695 Participants n=5 Participants	565 Participants n=7 Participants	1260 Participants n=5 Participants
Race (NIH/OMB) White	930 Participants n=5 Participants	818 Participants n=7 Participants	1748 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	63 Participants n=5 Participants	41 Participants n=7 Participants	104 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Bone Health Service Arm n=1688 Participants Interventional arm 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.	Usual Care (Control) Arm n=1424 Participants This arm represents a "no practice management support" control group.
Proportion of Participants Screened for Osteoporosis	830 participants	33 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Bone Health Service Arm n=413 Participants Interventional arm 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.	Usual Care (Control) Arm n=353 Participants This arm represents a "no practice management support" control group.
Bone Mineral Density T-score at the Femoral Neck	-0.55 T score femoral neck Standard Deviation 1.28	-0.70 T score femoral neck Standard Deviation 1.25

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Bone Health Service Arm n=1688 Participants Interventional arm 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.	Usual Care (Control) Arm n=1424 Participants This arm represents a "no practice management support" control group.
Gastrointestinal Medication Prescriptions	562 Participants	473 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Bone Health Service Arm n=113 Participants Interventional arm 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.	Usual Care (Control) Arm n=4 Participants This arm represents a "no practice management support" control group.
Osteoporosis Medication Adherence (Proportion of Days Covered)	0.92 proportion of days covered by meds Standard Deviation 0.24	1.0 proportion of days covered by meds Standard Deviation 0.13

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Bone Health Service Arm n=137 Participants Interventional arm 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.	Usual Care (Control) Arm n=9 Participants This arm represents a "no practice management support" control group.
Proportion of Patients Initiating Osteoporosis Medication (%)	113 Participants	4 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Bone Health Service Arm n=113 Participants Interventional arm 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.	Usual Care (Control) Arm n=4 Participants This arm represents a "no practice management support" control group.
Osteoporosis Medication Persistence (Days)	657 days Standard Deviation 366	730 days Standard Deviation 480

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Bone Health Service Arm n=1688 Participants Interventional arm 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.	Usual Care (Control) Arm n=1424 Participants This arm represents a "no practice management support" control group.
Proportion With Fractures	31 Participants	29 Participants

Adverse Events

Bone Health Service Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 135 deaths

Usual Care (Control) Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 89 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bone Health Service Arm n=1688 participants at risk Interventional arm 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.	Usual Care (Control) Arm n=1424 participants at risk This arm represents a "no practice management support" control group.
Endocrine disorders Drug interaction	0.06% 1/1688 • 2 years	0.00% 0/1424 • 2 years

Additional Information

Dr. Cathleen Colon-Emeric

Durham VA Geriatric Research Education and Clinical Center

Phone: 9192860411

Email: cathleen.colon-emeric@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place