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

Primary Purpose

Osteoporosis

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Added value of coordinator

About this trial

This is an interventional health services research trial for Osteoporosis focused on measuring Osteoporosis, hip fracture, fractures, Bone density

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

IRIS HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

usual care

Added value of coordinator

Arm Description

usual care

Added value of coordinator

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

New fractures.

Full Information

NCT ID

NCT01785381

First Posted

February 5, 2013

Last Updated

February 5, 2013

Sponsor

Centre Hospitalier Universitaire Saint Pierre

1. Study Identification

Unique Protocol Identification Number

NCT01785381

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

December 2012 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Hospitalier Universitaire Saint Pierre

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

Osteoporosis, hip fracture, fractures, Bone density

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

usual care

Arm Type

No Intervention

Arm Description

usual care

Arm Title

Added value of coordinator

Arm Type

Other

Arm Description

Added value of coordinator

Intervention Type

Other

Intervention Name(s)

Added value of coordinator

Intervention Description

Added value of coordinator

Primary Outcome Measure Information:

Title

A score of optimal management of osteoporosis.

Description

Time Frame

3-6 months

Secondary Outcome Measure Information:

Title

New fractures.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Katty Renard, RN

Phone

+32 2 535 48 56

katty_renard@stpierre-bru.be

Facility Information:

Facility Name

IRIS Hospitals

City

Brussels

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Innocent Nyaruhirira, MD

Phone

+32 485 93 25 44

innocent_nyaruhirira@stpierre-bru.be

First Name & Middle Initial & Last Name & Degree

Serge Rozenberg, MD

12. IPD Sharing Statement

Learn more about this trial

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

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