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

Not Applicable

• Conditions: Osteoporosis

• Registration Number: NCT01785381
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

Brief Summary

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

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 Timeline

• Study Start: 2012-12
• Status Verified: 2013-02
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-05
• Last Update Submitted: 2013-02-05
• Study First Posted: 2013-02-07
• Last Update Posted: 2013-02-07
• Primary Completion: 2013-03
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
A score of optimal management of osteoporosis.	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.

Secondary Outcome Measures

Name	Time	Method
New fractures.	2 years

Trial Locations

Locations (1)

IRIS Hospitals; 🇧🇪 Brussels, Belgium