Back to resultsPrimary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures (APROP)
Primary Purpose
Osteoporotic Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
community based integrated strategy for secondary prevention of OF
as usual
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporotic Fractures
Eligibility 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 ...)
Sites / Locations
- IDIAP Jordi GolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
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
Intervention as usual
Outcomes
Primary Outcome Measures
Number of patients with osteoporotic fractures
Secondary Outcome Measures
economic cost
We will consider time spent by physicians and nurses, cost of treatment (hospital admissions, drug therapy, rehabilitation)
Full Information
NCT ID
NCT03044015
First Posted
January 12, 2017
Last Updated
August 24, 2020
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Department of Health, Generalitat de Catalunya
1. Study Identification
Unique Protocol Identification Number
NCT03044015
Brief Title
Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures
Acronym
APROP
Official Title
a Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Department of Health, Generalitat de Catalunya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporotic Fractures
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Intervention as usual
Intervention Type
Behavioral
Intervention Name(s)
community based integrated strategy for secondary prevention of OF
Intervention Description
Educational programme on pharmacological treatment, diet recommendations, physical activity programme on OF prevention in primary care
Intervention Type
Behavioral
Intervention Name(s)
as usual
Primary Outcome Measure Information:
Title
Number of patients with osteoporotic fractures
Time Frame
24 months
Secondary Outcome Measure Information:
Title
economic cost
Description
We will consider time spent by physicians and nurses, cost of treatment (hospital admissions, drug therapy, rehabilitation)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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 ...)
Facility Information:
Facility Name
IDIAP Jordi Gol
City
Barcelona
ZIP/Postal Code
08007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Pueyo, MD
Phone
+34 93 556 62 13
Email
mjpueyo@gencat.cat
First Name & Middle Initial & Last Name & Degree
Bonaventura Bolibar
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures
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