OsteoporosisNCT02637180
Secondary Prevention of Osteoporotic Fractures: a Multiple Center Fracture Liaison Service in Greece
An observational study of Osteoporosis, run by Hellenic Society for the Study of Bone Metabolism at 4 sites in Greece.
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- anti-osteoporotic medication
- How many people
- 397 participants
- Where
- 4 sitesGreece
- Study dates
- Apr 2015to 7 Dec 2017
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 50 years old with low energy fractures
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Greece4 sites
Democritus University of Thrace, School of Medicine, Department of Orthopaedic Surgery
Alexandroupoli, Evros, 68100
NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS, MEDICAL SCHOOL, 2nd DEPARTMENT OF ORTHOPAEDIC SURGERY
Athens, Attica, 14233
Orthopaedic Department, Faculty of Medicine, School of Health Sciences, University of Thessalia
Larissa, 41110
Aristotle University of Thessaloniki, 3rd University Orthopaedic Department, Papageorgiou General Hospital
Thessaloniki, 56403
About this study
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
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.
Read the 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:
- Compiles and updates patient's file.
- 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.
- 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.
- Conditions
- Osteoporosis
- Being tested
- anti-osteoporotic medication
- Keywords
- osteoporosis, fracture, liaison service
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-osteoporotic medicationDrug
Also called all available anti-osteoporotic medication
check previous information
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: anti-osteoporotic medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate in the FLS program
Participation rate in the FLS program of patients with low-trauma fractures
Measured: 2 years
Secondary outcomes (3)
Percentage of patients initiating osteoporosis treatment
Measured: 2 years
percentage of patients experiencing subsequent fractures
Measured: 2 years
osteoporosis treatment adherence at 24 months [measured by Medication Possession Ratio (MPR)]
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startApr 2015
- Primary completion7 Dec 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 397 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hellenic Society for the Study of Bone Metabolism
- Sponsor type
- University, hospital or other
- Collaborators
- Democritus University of Thrace, Aristotle University Of Thessaloniki, UNIVERSITY OF THESSALIA, SCHOOL OF HEALTH SCIENCES, National and Kapodistrian University of Athens
- Responsible party
- Sponsor
- Investigators
- Christos Kosmidis, MD, Phd, Principal investigator, Hellenic Society for the Study of Bone Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637180
- Sponsor's protocol ID
- EEMMO/FLS/2015
- Status last verified
- Feb 2018
- First submitted
- 12 Dec 2015
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21607807McLellan 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.
PubMed 14600804Cooper 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.
PubMed 21953475Makras 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.
PubMed 22373950Dehamchia-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.
PubMed 24980182
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02637180
- Acronym / sponsor ID
- EEMMO/FLS/2015
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, fracture, liaison service
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Hellenic Society for the Study of Bone MetabolismUniversity, hospital or other
- Collaborators
- Democritus University of Thrace, Aristotle University Of Thessaloniki, UNIVERSITY OF THESSALIA, SCHOOL OF HEALTH SCIENCES, National and Kapodistrian University of Athens
- Study start
- Apr 2015 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Compiles and updates patient's file.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with low-energy fracture(s) | – | Drug: anti-osteoporotic medicationThe 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) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 50 years old with low energy fractures
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-osteoporotic medicationAlso: all available anti-osteoporotic medicationcheck previous information | Drug | patients with low-energy fracture(s) |
Primary outcome
Participation rate in the FLS program
Time frame: 2 years
Participation rate in the FLS program of patients with low-trauma fractures
3 secondary outcomes
Percentage of patients initiating osteoporosis treatment
Time frame: 2 years
percentage of patients experiencing subsequent fractures
Time frame: 2 years
osteoporosis treatment adherence at 24 months [measured by Medication Possession Ratio (MPR)]
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Background: PubMed 21607807Marsh 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.
- Background: PubMed 14600804McLellan 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.
- Background: PubMed 21953475Cooper 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.
- Background: PubMed 22373950Makras 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.
- Background: PubMed 24980182Dehamchia-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christos Kosmidis, MD, Phd principal investigator
Hellenic Society for the Study of Bone Metabolism
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Hellenic Society for the Study of Bone Metabolism at 4 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate in the FLS program (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02637180, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.