Secondary Prevention of Osteoporotic Fractures: a Multiple Center Fracture Liaison Service in Greece

Osteoporosis Clinical Trial

Official title:

A Multiple Center, Prospective Study Targeting the Secondary Prevention of Fractures in Greece: Evaluation of the Fracture Liaison Service in Multiple Hospital Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637180
• Other study ID #: EEMMO/FLS/2015
• Status: Completed
• Phase: N/A
• First received: December 12, 2015
• Last updated: February 22, 2018
• Start date: April 2015
• Est. completion date: December 7, 2017

Study information

• Verified date: February 2018
• Source: Hellenic Society for the Study of Bone Metabolism
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is multiple center, prospective study aiming to investigate the tracking and outcome of patients attending Greek General hospitals with low-trauma fractures. Secondary end-points were to facilitate the implementation of coordinated, multi-disciplinary models of care for secondary fracture prevention, and to monitor osteoporosis treatment initiation, osteoporosis treatment persistence at 12 months, compliance, and subsequent fractures.

Description:

This study includes 5 different hospitals in 4 cities of Greece. The responsible party in each hospital is an orthopedic department which will organize a fracture liaison service (FLS) for both Hospitalized patients over 50 years old with low energy fractures and Outpatients over 50 years old with low energy fractures (low energy fracture is defined as a fracture resulting from minimal trauma such as falling from standing height or less).

This action targets to improve patient care and to reduce secondary osteoporotic fractures, along with collateral healthcare cost.

Prerequisite for patients' enrollment in the FLS program is the voluntary signed acceptance of the program's terms and conditions (signed Inform Consent Forms).

Program Services for eligible patients include the following steps:

• The FLS personnel informs patient about the program, its services and provides him/her with the relevant, informative, printed material. After obtaining patient's signed informed consent, the competent personnel in cooperation with treating physicians:

1. Compiles and updates patient's file.

2. Ensures that diagnostics and laboratory tests will include: Hip and Lumbar Spine BMD (of at least one hip, in two points of lumbar spine if possible); Thoracic Spine F/P & Lumbar Spine F/P X-rays; and the minimum required laboratory test for patients with low energy fracture, that are candidates to receive "anti-osteoporotic" medication, according to Greek osteoporosis guidelines. Calculates the relevant FRAX score.

3) Assures that treating physician (or the physician accountable for the bone metabolic disorders) recommends a treatment for the prevention of a new fracture, if appropriate, after patient's examination and before patient leaves hospital.

• The FLS personnel ensures the restoration of regular contact with the fractured patients, aiming to inform and alert them (and/or their relatives, families), by reminding and facilitating the next appointment in outpatient office for Metabolic Bone Diseases.

• The FLS personnel compiles and applies a patient support program, with regular telephone contacts. The program informs, awares, motivates and facilitates patients to follow up with a specialized physician, by providing useful information or/and services (for example: to schedule the next appointment in the specific hospital's outpatient office). During the telephone contact specific data will be collected and recorded, such as if a new fracture has emerged, if patient is under regular supervision / follow up by physician for osteoporosis, if patient is still under treatment. If not the discontinuation reason should be collected. The telephone contact schedule will be as follows: One, six and twelve months after discharge from hospital.

The enrollment period lasts 365 days in each hospital, starting from first patient's enrollment date in each particular center. Patients' follow up will also last 365 days and therefore the total duration of the program is 2 years in every center.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: December 7, 2017
• Est. primary completion date: December 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized patients and Outpatients over 50 years old with low energy fractures (low energy fracture is defined as a fracture resulting from minimal trauma such as falling from standing height or less).

Exclusion Criteria:

• Presence of osteomalacia and/or other clinical entities predisposing to low energy fractures, apart from osteoporosis, such as primary or secondary hyperparathyroidism, Paget's disease of bone, osteogenesis imperfecta and paraplegia.

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Osteoporotic Fractures

Intervention

Drug:
• anti-osteoporotic medication
check previous information

Locations

Country	Name	City	State
Greece	Democritus University of Thrace, School of Medicine, Department of Orthopaedic Surgery	Alexandroupolis	Evros
Greece	NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS, MEDICAL SCHOOL, 2nd DEPARTMENT OF ORTHOPAEDIC SURGERY	Athens	Attiki
Greece	Orthopaedic Department, Faculty of Medicine, School of Health Sciences, University of Thessalia	Larissa
Greece	Aristotle University of Thessaloniki, 3rd University Orthopaedic Department, Papageorgiou General Hospital	Thessaloniki

Sponsors (5)

Lead Sponsor	Collaborator
Hellenic Society for the Study of Bone Metabolism	Aristotle University Of Thessaloniki, Democritus University of Thrace, National and Kapodistrian University of Athens, UNIVERSITY OF THESSALIA, SCHOOL OF HEALTH SCIENCES

Country where clinical trial is conducted

Greece, 

References & Publications (5)

Cooper MS, Palmer AJ, Seibel MJ. Cost-effectiveness of the Concord Minimal Trauma Fracture Liaison service, a prospective, controlled fracture prevention study. Osteoporos Int. 2012 Jan;23(1):97-107. doi: 10.1007/s00198-011-1802-z. Epub 2011 Sep 28. — View Citation

Dehamchia-Rehailia N, Ursu D, Henry-Desailly I, Fardellone P, Paccou J. Secondary prevention of osteoporotic fractures: evaluation of the Amiens University Hospital's fracture liaison service between January 2010 and December 2011. Osteoporos Int. 2014 Oct;25(10):2409-16. doi: 10.1007/s00198-014-2774-6. Epub 2014 Jul 1. — View Citation

Makras P, Vaiopoulos G, Lyritis GP; Greek National Medicine Agency. 2011 guidelines for the diagnosis and treatment of osteoporosis in Greece. J Musculoskelet Neuronal Interact. 2012 Mar;12(1):38-42. — View Citation

Marsh D, Akesson K, Beaton DE, Bogoch ER, Boonen S, Brandi ML, McLellan AR, Mitchell PJ, Sale JE, Wahl DA; IOF CSA Fracture Working Group. Coordinator-based systems for secondary prevention in fragility fracture patients. Osteoporos Int. 2011 Jul;22(7):2051-65. doi: 10.1007/s00198-011-1642-x. Epub 2011 May 24. Review. — View Citation

McLellan AR, Gallacher SJ, Fraser M, McQuillian C. The fracture liaison service: success of a program for the evaluation and management of patients with osteoporotic fracture. Osteoporos Int. 2003 Dec;14(12):1028-34. Epub 2003 Nov 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation rate in the FLS program	Participation rate in the FLS program of patients with low-trauma fractures	2 years
Secondary	Percentage of patients initiating osteoporosis treatment		2 years
Secondary	percentage of patients experiencing subsequent fractures		2 years
Secondary	osteoporosis treatment adherence at 24 months [measured by Medication Possession Ratio (MPR)]		2 years