RCT: Added Value of Coordinator for the Management of Hip Fracture Patients

NCT ID: NCT01785381

Last Updated: 2013-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-12-31

Brief Summary

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Introduction: Hip fracture due to osteoporosis is associated with an extremely high mortality morbidity and loss of quality of life. The risk of future fracture after a first hip fracture is increased. Several studies reported that patients who suffered from a fracture are not optimally treated and do not receive osteoporosis treatment after the first fracture episode.

Aim: To evaluate whether a coordinator increases the optimal management of osteoporotic fracture patients and hip fracture patients.

Detailed Description

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Material and methods: Population: Identification in the "IRIS public hospital network of all patients above 50 years" who suffer from hip fracture. Exclusion of those due to high energy fractures and due to known cancer.

First observational phase of treatment followed by randomized controlled trials of 2 years.

Intervention (RCT): Added value of a coordinator. Measured outcomes : A. New fractures. B. A score of optimal management of osteoporosis.

Definition of the score and management: 1. Realization of a bone density measurement. 2. Identification of secondary osteoporosis. 3. Identification of risk factors and calculation of the probability of a future fracture using FRAX score. 4. Attempt to correct risk factors of osteoporosis when possible. 5. Prevention of falls. 6. Prescription of calcium and vitamin D. 7. Prescription of a medical osteoporosis treatment. 8. Report to the general practitioner.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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usual care

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Added value of coordinator

Added value of coordinator

Group Type OTHER

Added value of coordinator

Intervention Type OTHER

Added value of coordinator

Interventions

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Added value of coordinator

Added value of coordinator

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Identification in the "IRIS public hospital network of all patients above 50 years" who suffer from hip fracture.

Exclusion Criteria

* Exclusion of those due to high energy fractures and due to known cancer.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role lead

Responsible Party

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Nyaruhirira Innocent

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRIS Hospitals

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Katty Renard, RN

Role: CONTACT

+32 2 535 48 56

Facility Contacts

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Innocent Nyaruhirira, MD

Role: primary

+32 485 93 25 44

Other Identifiers

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IRIS recherche 2012820690007

Identifier Type: -

Identifier Source: org_study_id

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