Primary Care Based Intervention for the Secondary Prevent... | NCT03044015

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

NCT03044015

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status

Unknown status

Last Update Posted

Aug 26, 2020Actual

Enrollment

1,800Estimated

Phase

Not Applicable

Conditions

Osteoporotic Fractures

Interventions

community based integrated strategy for secondary prevention of OF
as usual

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Jan 12, 2017

First Submission Date that Met QC Criteria

Feb 2, 2017

First Posted Date

Feb 6, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2020

Last Update Posted Date

Aug 26, 2020Actual

Name	Class
Department of Health, Generalitat de Catalunya	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with osteoporotic fractures		24 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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 ...)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IDIAP Jordi Gol	Recruiting	Barcelona		08007	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058866	Osteoporotic Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided