Secondary Prevention of Osteoporotic Fractures: a Multiple Center Fracture Liaison Service in Greece
- Conditions
- Osteoporosis
- Interventions
- Drug: anti-osteoporotic medication
- Registration Number
- NCT02637180
- Lead Sponsor
- Hellenic Society for the Study of Bone Metabolism
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 397
- 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).
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patients with low-energy fracture(s) anti-osteoporotic medication 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)
- Primary Outcome Measures
Name Time Method Participation rate in the FLS program 2 years Participation rate in the FLS program of patients with low-trauma fractures
- Secondary Outcome Measures
Name Time Method osteoporosis treatment adherence at 24 months [measured by Medication Possession Ratio (MPR)] 2 years Percentage of patients initiating osteoporosis treatment 2 years percentage of patients experiencing subsequent fractures 2 years
Trial Locations
- Locations (4)
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, Greece
NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS, MEDICAL SCHOOL, 2nd DEPARTMENT OF ORTHOPAEDIC SURGERY
🇬🇷Athens, Attiki, Greece
Democritus University of Thrace, School of Medicine, Department of Orthopaedic Surgery
🇬🇷Alexandroupolis, Evros, Greece