a Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoporotic Fractures
- Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Enrollment
- 1800
- Locations
- 1
- Primary Endpoint
- Number of patients with osteoporotic fractures
- Last Updated
- 5 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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 ...)
Outcomes
Primary Outcomes
Number of patients with osteoporotic fractures
Time Frame: 24 months
Secondary Outcomes
- economic cost(24 months)