Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures

Osteoporotic Fractures Clinical Trial

— APROP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03044015
• Other study ID #: PDMRAL-16
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2021

Study information

• Verified date: February 2020
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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 ...)

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporotic Fractures

Intervention

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
• as usual

Locations

Country	Name	City	State
Spain	IDIAP Jordi Gol	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Department of Health, Generalitat de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with osteoporotic fractures		24 months
Secondary	economic cost	We will consider time spent by physicians and nurses, cost of treatment (hospital admissions, drug therapy, rehabilitation)	24 months