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Clinical Trials/NCT01785381
NCT01785381
Unknown
Not Applicable

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

Centre Hospitalier Universitaire Saint Pierre1 site in 1 country128 target enrollmentStarted: December 2012Last updated:
ConditionsOsteoporosis

Overview

Phase
Not Applicable
Sponsor
Centre Hospitalier Universitaire Saint Pierre
Enrollment
128
Locations
1
Primary Endpoint
A score of optimal management of osteoporosis.

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • New fractures.(2 years)

Investigators

Sponsor
Centre Hospitalier Universitaire Saint Pierre
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nyaruhirira Innocent

MD

Centre Hospitalier Universitaire Saint Pierre

Study Sites (1)

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