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Screening Models for Osteoporosis in Male Veterans (MOPS Trial)
N/A
Waitlist Available
Led By Cathleen S Colon-Emeric, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
PACT Team inclusion criteria: Care for male Veterans >65 years (i.e., Women's Health PACTs are excluded)
Patient Inclusion criteria: No prior fracture or osteoporosis diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 5
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing different care models for osteoporosis screening in male veterans, to see which is most effective in terms of patient, provider, and facility outcomes.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on screening models rather than medication or invasive procedures, there are no direct side effects associated with the interventions being tested.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a male Veteran over 65 receiving care.
Select...
I have never been diagnosed with a fracture or osteoporosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 5
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bone Mineral Density (gram/sq centimeter)
Harms (%)
Medication Discontinuation (days)
+4 moreSecondary study objectives
Bone Disease Clinic Volume (Consults per year)
DXA volume (DEXA rate per year)
Fractures (% with fracture in last 2 years)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bone Health Service armExperimental Treatment1 Intervention
Interventional arm
Group II: Usual care (control) armActive Control1 Intervention
This arm represents a "no practice management support" control group.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,765 Total Patients Enrolled
5 Trials studying Osteoporosis
57,366 Patients Enrolled for Osteoporosis
Cathleen S Colon-Emeric, MDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a male Veteran over 65 receiving care.Patients enrolled in years 4 or 5 need to meet at least one criterion for osteoporosis screening as outlined in the PACT enrollment protocol.I am a man aged between 65 and 85.Not applicable.I have at least one health issue like significant weight loss, diabetes, or heart disease.I have never been diagnosed with a fracture or osteoporosis.
Research Study Groups:
This trial has the following groups:- Group 1: Bone Health Service arm
- Group 2: Usual care (control) arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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