Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03044015

Acronym

APROP

Enrollment

1800

Registered

2017-02-06

Start date

2017-01-31

Completion date

2021-12-31

Last updated

2020-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporotic Fractures

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

Interventions

BEHAVIORALcommunity based integrated strategy for secondary prevention of OF

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

BEHAVIORALas usual

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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 ...)

Design outcomes

Primary

Measure	Time frame
Number of patients with osteoporotic fractures	24 months

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026