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

NCT02637180 | Completed

• 1 other identifier: EEMMO/FLS/2015
• Study Type: observational
• Target: 397
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Osteoporosis

Keywords

osteoporosis; fracture; liaison service

Outcome Measures

Primary Outcomes (1)

• Participation rate in the FLS program

  Participation rate in the FLS program of patients with low-trauma fractures

  2 years

Secondary Outcomes (3)

• Percentage of patients initiating osteoporosis treatment

  2 years

• percentage of patients experiencing subsequent fractures

  2 years

• osteoporosis treatment adherence at 24 months [measured by Medication Possession Ratio (MPR)]

  2 years

Study Arms (1)

patients with low-energy fracture(s)

The study will include patients from pre-defined groups of individuals (postmenopausal, perimenopausal, male, and steroid induced osteoporosis) who would be anyway eligible to receive treatment for their condition according to standard medical practice and Greek treatment guidelines. Drug: anti-osteoporotic medication (bisphosphonates, denosumab, strontium ranelate, teriparatide, SERMs)

Drug: anti-osteoporotic medication

Interventions

anti-osteoporotic medication DRUG

check previous information

Also known as: all available anti-osteoporotic medication

patients with low-energy fracture(s)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 50 years old with low energy fractures

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hellenic Society for the Study of Bone Metabolism: lead
• Democritus University of Thrace: collaborator
• Aristotle University Of Thessaloniki: collaborator
• UNIVERSITY OF THESSALIA, SCHOOL OF HEALTH SCIENCES: collaborator
• National and Kapodistrian University of Athens: collaborator

Study Sites (4)

NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS, MEDICAL SCHOOL, 2nd DEPARTMENT OF ORTHOPAEDIC SURGERY

Athens, Attica, 14233, Greece

Location

Democritus University of Thrace, School of Medicine, Department of Orthopaedic Surgery

Alexandroupoli, Evros, 68100, Greece

Location

Orthopaedic Department, Faculty of Medicine, School of Health Sciences, University of Thessalia

Larissa, 41110, Greece

Location

Aristotle University of Thessaloniki, 3rd University Orthopaedic Department, Papageorgiou General Hospital

Thessaloniki, 56403, Greece

Location

Related Publications (5)

• 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.

  PMID: 21607807 BACKGROUND

• 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. doi: 10.1007/s00198-003-1507-z. Epub 2003 Nov 5.

  PMID: 14600804 BACKGROUND

• 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.

  PMID: 21953475 BACKGROUND

• 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. No abstract available.

  PMID: 22373950 BACKGROUND

• 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.

  PMID: 24980182 BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Study Officials

• Christos Kosmidis, MD, Phd

  Hellenic Society for the Study of Bone Metabolism

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2015
• First Posted: December 22, 2015
• Study Start: April 1, 2015
• Primary Completion: December 7, 2017
• Study Completion: December 7, 2017
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

GR (4)