Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures (APROP)

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Unknown

Conditions: Osteoporotic Fractures

Treatments: Behavioral: as usual; Behavioral: community based integrated strategy for secondary prevention of OF

Study type: Interventional

Funder types: Other

Identifiers

NCT03044015

PDMRAL-16

Details and patient eligibility

About

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

Enrollment: 1,800 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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 ...)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,800 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: community based integrated strategy for secondary prevention of OF

Control

Active Comparator group

Description:

Intervention as usual

Treatment:

Behavioral: as usual