Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures (APROP)
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|ClinicalTrials.gov Identifier: NCT03044015|
Recruitment Status : Unknown
Verified February 2017 by Jordi Gol i Gurina Foundation.
Recruitment status was: Recruiting
First Posted : February 6, 2017
Last Update Posted : February 6, 2017
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.
- 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
|Condition or disease||Intervention/treatment||Phase|
|Osteoporotic Fractures||Behavioral: community based integrated strategy for secondary prevention of OF Behavioral: as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||a Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2019|
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
Educational programme on pharmacological treatment, diet recommendations, physical activity programme on OF prevention in primary care
Active Comparator: Control
Intervention as usual
Behavioral: as usual
- Number of patients with osteoporotic fractures [ Time Frame: 24 months ]
- Quality of life [ Time Frame: 24 months ]EuroQol 5D scale
- economic cost [ Time Frame: 24 months ]We will consider time spent by physicians and nurses, cost of treatment (hospital admissions, drug therapy, rehabilitation)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044015
|IDIAP Jordi Gol||Recruiting|
|Barcelona, Spain, 08007|
|Contact: Maria Pueyo, MD +34 93 556 62 13 email@example.com|
|Principal Investigator: Bonaventura Bolibar|