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Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures

NCT03044015 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2020-08-26

No results posted yet for this study

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

Conditions

  • Osteoporotic Fractures

Interventions

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

BEHAVIORAL

as usual

Sponsors & Collaborators

  • Department of Health, Generalitat de Catalunya

    collaborator OTHER_GOV

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03044015 on ClinicalTrials.gov