- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03044015
Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures (APROP)
a Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures
BACKGROUND Recent evidence has been published about the effectiveness for the secondary prevention of osteoporotic fractures (OF) of the hospital-based fracture liaison services.
AIM To assess the effectiveness of a primary care based intervention in the secondary prevention of OF.
METHODOLOGY Prospective study of random clusters, defined at the primary-care trust (PCT) level. Total study follow-up 3 years. Sample size 1800 patients.
DESCRIPTION To launch a defined strategy for the identification of OF. To carry out a primary care based intervention about lifestyle, diet and drug prescription, if needed, with an intensive follow-up in the intervention PCT vs treatment as usual in the control branch.
ANALYSIS As the outcome are the new OF, a survival analysis will be done. Risk factors will be analyzed through Cox proportional hazard regression model stratified by age groups.
Outcomes :
- new OF ratio in intervention vs control areas.
- maintenance of the adherence to the pharmacological and non pharmacological interventions proposed
- assessment of cost-effectivity of the intervention
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08007
- Recruiting
- IDIAP Jordi Gol
-
Contact:
- Maria Pueyo, MD
- Phone Number: +34 93 556 62 13
- Email: mjpueyo@gencat.cat
-
Principal Investigator:
- Bonaventura Bolibar
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Major OF (distal forearm, vertebral, hip, pelvis and humerus
- Caused by a low impact mechanism
Exclusion Criteria:
- High impact mechanism of impact or secondary to other diseases (cancer, Paget disease ...)
- Patients not residing in the area of the targeted primary care practices
- Patients with an invalidating disease (dementia ...)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
a defined strategy for the identification of OF.
To carry out a primary care based intervention about lifestyle, diet and drug prescription, if needed, with an intensive follow-up
|
Educational programme on pharmacological treatment, diet recommendations, physical activity programme on OF prevention in primary care
|
Active Comparator: Control
Intervention as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with osteoporotic fractures
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
economic cost
Time Frame: 24 months
|
We will consider time spent by physicians and nurses, cost of treatment (hospital admissions, drug therapy, rehabilitation)
|
24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PDMRAL-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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