Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures

NCT03044015 | Unknown

• 1 other identifier: PDMRAL-16
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoporotic Fractures

Outcome Measures

Primary Outcomes (1)

• Number of patients with osteoporotic fractures

  24 months

Secondary Outcomes (1)

• economic cost

  24 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Intervention as usual

Behavioral: as usual

Interventions

community based integrated strategy for secondary prevention of OF BEHAVIORAL

Educational programme on pharmacological treatment, diet recommendations, physical activity programme on OF prevention in primary care

Intervention

as usual BEHAVIORAL

Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major OF (distal forearm, vertebral, hip, pelvis and humerus
• Caused by a low impact mechanism

You may not qualify if:

• 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 ...)

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Department of Health, Generalitat de Catalunya: collaborator

Study Sites (1)

IDIAP Jordi Gol

Barcelona, 08007, Spain

RECRUITING

MeSH Terms

Conditions

Osteoporotic Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: February 6, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)