Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures

Study Overview
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Brief Summary
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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

Official Title
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a Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures

Conditions
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Osteoporotic Fractures

Intervention / Treatment
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* Behavioral: community based integrated strategy for secondary prevention of OF
* Behavioral: as usual


Participation Criteria
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Eligibility Criteria
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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 ...)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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 | Behavioral: community based integrated strategy for secondary prevention of OF<br>* Educational programme on pharmacological treatment, diet recommendations, physical activity programme on OF prevention in primary care<br>|
| Active Comparator: Control<br>Intervention as usual | Behavioral: as usual<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with osteoporotic fractures |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| economic cost | We will consider time spent by physicians and nurses, cost of treatment (hospital admissions, drug therapy, rehabilitation) | 24 months |