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

February 5, 2013 updated by: Nyaruhirira Innocent, Centre Hospitalier Universitaire Saint Pierre

Randomized Controlled Trial: Added Value of Coordinator for the Management of Hip Fracture Patients in a Network of Public Hospitals in Brussels.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: usual care
Other: Added value of coordinator
Other: Added value of coordinator
Added value of coordinator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A score of optimal management of osteoporosis.
Time Frame: 3-6 months
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.
3-6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
New fractures.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRIS recherche 2012820690007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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