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

August 24, 2020 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08007
        • Recruiting
        • IDIAP Jordi Gol
        • Contact:
        • Principal Investigator:
          • Bonaventura Bolibar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with osteoporotic fractures
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
economic cost
Time Frame: 24 months
We will consider time spent by physicians and nurses, cost of treatment (hospital admissions, drug therapy, rehabilitation)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Department of Health, Generalitat de Catalunya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (Estimate)

February 6, 2017

Study Record Updates

Last Update Posted (Actual)

August 26, 2020

Last Update Submitted That Met QC Criteria

August 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDMRAL-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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