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

February 22, 2018 updated by: Hellenic Society for the Study of Bone Metabolism

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

397

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Larissa, Greece, 41110
        • Orthopaedic Department, Faculty of Medicine, School of Health Sciences, University of Thessalia
      • Thessaloniki, Greece, 56403
        • Aristotle University of Thessaloniki, 3rd University Orthopaedic Department, Papageorgiou General Hospital
    • Attiki
      • Athens, Attiki, Greece, 14233
        • NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS, MEDICAL SCHOOL, 2nd DEPARTMENT OF ORTHOPAEDIC SURGERY
    • Evros
      • Alexandroupolis, Evros, Greece, 68100
        • Democritus University of Thrace, School of Medicine, Department of Orthopaedic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients over 50 years old with low energy fractures

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
check previous information
Other Names:
  • all available anti-osteoporotic medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation rate in the FLS program
Time Frame: 2 years
Participation rate in the FLS program of patients with low-trauma fractures
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients initiating osteoporosis treatment
Time Frame: 2 years
2 years
percentage of patients experiencing subsequent fractures
Time Frame: 2 years
2 years
osteoporosis treatment adherence at 24 months [measured by Medication Possession Ratio (MPR)]
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Society for the Study of Bone Metabolism

Collaborators

Aristotle University Of Thessaloniki
National and Kapodistrian University of Athens
Democritus University of Thrace
UNIVERSITY OF THESSALIA, SCHOOL OF HEALTH SCIENCES

Investigators

  • Principal Investigator: Christos Kosmidis, MD, Phd, Hellenic Society for the Study of Bone Metabolism

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2015

Primary Completion (ACTUAL)

December 7, 2017

Study Completion (ACTUAL)

December 7, 2017

Study Registration Dates

First Submitted

December 12, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (ESTIMATE)

December 22, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EEMMO/FLS/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoporosis

Clinical Trials on anti-osteoporotic medication

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe