Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures

Not Applicable

• Conditions: Osteoporotic Fractures
• Interventions: Behavioral: community based integrated strategy for secondary prevention of OF; Behavioral: as usual

• Registration Number: NCT03044015
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-06
• Status Verified: 2020-02
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-26
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	community based integrated strategy for secondary prevention of OF	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
Control	as usual	Intervention as usual

Primary Outcome Measures

Name	Time	Method
Number of patients with osteoporotic fractures	24 months

Secondary Outcome Measures

Name	Time	Method
economic cost	24 months	We will consider time spent by physicians and nurses, cost of treatment (hospital admissions, drug therapy, rehabilitation)

Trial Locations

Locations (1)

IDIAP Jordi Gol; 🇪🇸 Barcelona, Spain