Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044015
Recruitment Status : Unknown
Verified February 2017 by Jordi Gol i Gurina Foundation.
Recruitment status was:  Recruiting
First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Collaborator:
Department of Health, Generalitat de Catalunya
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

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

Condition or disease Intervention/treatment Phase
Osteoporotic Fractures Behavioral: community based integrated strategy for secondary prevention of OF Behavioral: as usual Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: a Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures
Study Start Date : January 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Number of patients with osteoporotic fractures [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 24 months ]
    EuroQol 5D scale

  2. economic cost [ Time Frame: 24 months ]
    We will consider time spent by physicians and nurses, cost of treatment (hospital admissions, drug therapy, rehabilitation)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044015


Locations
Layout table for location information
Spain
IDIAP Jordi Gol Recruiting
Barcelona, Spain, 08007
Contact: Maria Pueyo, MD    +34 93 556 62 13    mjpueyo@gencat.cat   
Principal Investigator: Bonaventura Bolibar         
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Department of Health, Generalitat de Catalunya

Layout table for additonal information
Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT03044015    
Other Study ID Numbers: PDMRAL-16
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Osteoporotic Fractures
Wounds and Injuries