Trial · NCT04079868

Models of Primary Osteoporosis Screening in Male Veterans

NCT04079868, Not applicable, Completed, VA Office of Research and Development; results first posted 2025-10-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Models of Primary Osteoporosis Screening in Male Veterans. Trials, record NCT04079868. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04079868

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Models of Primary Osteoporosis Screening in Male Veterans
NCT number: NCT04079868
Status: Completed
Phases: Not applicable
Enrollment: 3,512 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Osteoporosis, Osteopenia, Osteoporotic Fracture
Interventions: Bone Health Service Model
First posted: 2019-09-06
Last updated: 2025-10-14
Results first posted: 2025-10-14

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Participants Screened for Osteoporosis	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
Primary	Bone Mineral Density T-score at the Femoral Neck	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.
Secondary	Gastrointestinal Medication Prescriptions	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
Secondary	Osteoporosis Medication Adherence (Proportion of Days Covered)	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
Secondary	Proportion of Patients Initiating Osteoporosis Medication (%)	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
Secondary	Osteoporosis Medication Persistence (Days)	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
Secondary	Proportion With Fractures	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

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Proportion of Participants Screened for Osteoporosis	through study completion, an average of 1.5 years	participants	NUMBER
PRIMARY	Bone Mineral Density T-score at the Femoral Neck	2 years after the primary care team's start date	T score femoral neck	MEAN
SECONDARY	Gastrointestinal Medication Prescriptions	through study completion, an average of 1.5 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Osteoporosis Medication Adherence (Proportion of Days Covered)	through study completion, an average of 1.5 years	proportion of days covered by meds	MEAN
SECONDARY	Proportion of Patients Initiating Osteoporosis Medication (%)	through study completion, an average of 1.5 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Osteoporosis Medication Persistence (Days)	through study completion, up to 2 years	days	MEAN
SECONDARY	Proportion With Fractures	through study completion, an average of 1.5 years	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Proportion of Participants Screened for Osteoporosis	Bone Health Service Arm	830		participants
Proportion of Participants Screened for Osteoporosis	Usual Care (Control) Arm	33		participants
Bone Mineral Density T-score at the Femoral Neck	Bone Health Service Arm	-0.55	Standard Deviation 1.28	T score femoral neck
Bone Mineral Density T-score at the Femoral Neck	Usual Care (Control) Arm	-0.70	Standard Deviation 1.25	T score femoral neck
Gastrointestinal Medication Prescriptions	Bone Health Service Arm	562		Participants
Gastrointestinal Medication Prescriptions	Usual Care (Control) Arm	473		Participants
Osteoporosis Medication Adherence (Proportion of Days Covered)	Bone Health Service Arm	0.92	Standard Deviation 0.24	proportion of days covered by meds
Osteoporosis Medication Adherence (Proportion of Days Covered)	Usual Care (Control) Arm	1.0	Standard Deviation 0.13	proportion of days covered by meds
Proportion of Patients Initiating Osteoporosis Medication (%)	Bone Health Service Arm	113		Participants
Proportion of Patients Initiating Osteoporosis Medication (%)	Usual Care (Control) Arm	4		Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted
Overall Study	STARTED	Bone Health Service Arm	1,888	20
Overall Study	STARTED	Usual Care (Control) Arm	1,624	19
Overall Study	COMPLETED	Bone Health Service Arm	1,688	18
Overall Study	COMPLETED	Usual Care (Control) Arm	1,424	17
Overall Study	NOT COMPLETED	Bone Health Service Arm	200	2
Overall Study	NOT COMPLETED	Usual Care (Control) Arm	200	2

Source ClinicalTrials.gov

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Drug interaction	Endocrine disorders	Bone Health Service Arm	1	1,688
other	Drug interaction	Endocrine disorders	Usual Care (Control) Arm	0	1,424

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bone Health Service Arm	135	1,688
Total, all-cause mortality	Usual Care (Control) Arm	89	1,424
Total, other adverse events	Bone Health Service Arm	1	1,688
Total, other adverse events	Usual Care (Control) Arm	0	1,424
Total, serious adverse events	Bone Health Service Arm	0	1,688
Total, serious adverse events	Usual Care (Control) Arm	0	1,424

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40853653	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Bone Health Service Arm vs Usual Care (Control) Arm: Proportion With Fractures	Trial comparisons
Bone Health Service Arm vs Usual Care (Control) Arm: Proportion of Participants Screened for Osteoporosis	Trial comparisons
Bone Health Service Arm vs Usual Care (Control) Arm: Proportion of Patients Initiating Osteoporosis Medication (%)	Trial comparisons
Bone Health Service Arm vs Usual Care (Control) Arm: Gastrointestinal Medication Prescriptions	Trial comparisons
Bone Health Service Arm vs Usual Care (Control) Arm: deaths from any cause	Trial comparisons
Bone Health Service Arm vs Usual Care (Control) Arm: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04079868

GET https://conductscience.org/api/trials/v1/NCT04079868/registered

API reference For AI assistants