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

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ClinicalTrials.gov Identifier: NCT01785381
Recruitment Status : Unknown
Verified February 2013 by Nyaruhirira Innocent, Centre Hospitalier Universitaire Saint Pierre.
Recruitment status was:  Recruiting
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):
Nyaruhirira Innocent, 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.


Condition or disease Intervention/treatment Phase
Osteoporosis Other: Added value of coordinator Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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 Start Date : December 2012
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: usual care
usual care
Added value of coordinator
Added value of coordinator
Other: Added value of coordinator
Added value of coordinator




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. New fractures. [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785381


Contacts
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Contact: Katty Renard, RN +32 2 535 48 56 katty_renard@stpierre-bru.be

Locations
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Belgium
IRIS Hospitals Recruiting
Brussels, Belgium
Contact: Innocent Nyaruhirira, MD    +32 485 93 25 44    innocent_nyaruhirira@stpierre-bru.be   
Principal Investigator: Serge Rozenberg, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre

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Responsible Party: Nyaruhirira Innocent, MD, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT01785381     History of Changes
Other Study ID Numbers: IRIS recherche 2012820690007
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013
Keywords provided by Nyaruhirira Innocent, Centre Hospitalier Universitaire Saint Pierre:
Osteoporosis, hip fracture, fractures, Bone density
Additional relevant MeSH terms:
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Osteoporosis
Hip Fractures
Fractures, Bone
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Femoral Fractures
Hip Injuries
Leg Injuries