OsteoporosisNCT02194660
Fragility Fracture Liaison Service Project
An observational study of Osteoporosis and Fracture, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and its Beihu Branch (BB). Method: From Jan., 2014, two related fracture liaison services (FLSs) following the 13 'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan University Hospital (NTUH)… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis, Fracture
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to May 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: new fragility fracture
Who may be able to join
- age >=50 years and
- new hip fracture in orthopedic ward
- newly identified radiographic vertebral fractures from plan films in geriatric ward
- clinical vertebral fractures in outpatient clinics Inclusion criteria (Beihu branch, only outpatients)
- age >=50 years and
- newly identified radiographic vertebral fractures from plan films
- clinical vertebral fractures
Who cannot join
- fracture is sufer from trauma or cancer
- atypical fractures
- Life expectancy less than 2 years or can't be assessed for communication or cognitive problems
- patient in other medication clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and its Beihu Branch (BB).
Method: From Jan., 2014, two related fracture liaison services (FLSs) following the 13 'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan University Hospital (NTUH) health care system. The main hospital (MH) program enrolled patient with 1) new hip fracture 2) newly identified radiographic vertebral fractures or 3) clinical vertebral fractures from both inpatients and outpatients. The Beihu branch (BB) program enrolled only the later two types of patients from outpatients. During the whole study period, two programs planed to enroll 600 fracture patients. Each patient would be assessed at baseline, and every 4 month for at least one year.
Read the detailed description
Background:The Asia Fracture Gap Taiwan Study (AFGTS) showed that among fragility fracture sufferers, only 1/4 of them underwent bone mineral density (BMD) tests and 1/3 of them received treatments for osteoporosis. Secondary fragility fracture prevention services are needed to improve the care gaps
. Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and its Beihu Branch (BB).
Method: The FLS was designed following the 13 'Capture the Fracture Best Practice Standards'. The National Taiwan University Hospital (NTUH) institutional review board approved the study in Jan., 2014. Patients were eligible to be enrolled into the main hospital (MH) service if they had
- new hip fracture in orthopedic ward
- newly identified radiographic vertebral fractures from plan films in geriatric ward or
- clinical vertebral fractures in outpatient clinics.
Patients in outpatient clinics of BB were eligible to be enrolled if they had (1) clinical vertebral fractures or (2) newly identified asymtomatic radiological vertebral fractures by a routine weekly review of every plan film of thoracic or lumbar spine regardless of the reason for it.They were excluded from the service if they had life expectancy shorter than 2 years of life or not be able to complete study assessments for communication or cognitive problems.
Osteoporosis-related assessments, treatments, consultations on diet, medications, exercise, fall prevention were given mainly by care managers. A system is set up to remind patients to take their medications at home or to return to clinic for regular injections of medications. Follow up assessments included adherence to education instructions, medications, fall and fracture incidences. During the whole study period, we planed to enroll 600 fracture patients. Each patient would be assessed at baseline, and every 4 months last for two years.
Anticipated results:
Establish domestic FLS model and database Publish preliminary results at the 2014 the IOF 5th Regionals Asia Pacific Meeting in Taipei in November.
Participating physicians and care managers will learn new skills in managing osteoporosis patients.
Application for Best Practice Recognition for the IOF Capture the Fracture Campaign
Preliminary results:
We have enrolled 371 eligible patients into FLS services. From the NTUH program, BMD tests were completed within 8 weeks for over 90% of participants. Also, anti-osteoporosis medication (AOMs) were prescribed to about 90% of participants eligible for National Health Insurance reimbursements.
In 2014, National Taiwan University Hospital (NTUH) and its BeiHu Branch (BB) were awarded the gold medal and silver medal accredited best practice programs from the 'Capture the Fracture' campaign from International Osteoporosis Foundation, respectively.
Our preliminary results were presented at annual scientific meeting of the Taiwanese Osteoporosis Association, at Madrid, Spain, and the IOF 5th Regionals Asia Pacific Meeting in Taipei, Taiwan, and the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases, at Milan, Italy.
- Conditions
- Osteoporosis, Fracture
- Keywords
- Fractures Liaison Service, Osteoporosis, Fracture, Medication adherence
- Medical subject headings
- Osteoporosis, Fractures, Bone, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| M- main hospital | Patient enrolled in the main hospital | |
| B- Beihu branch | Patients enrolled in the Beihu branch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density test within 8 weeks of enrollments
Capture the fracture campaign provide 13 best practice standards. The above mentioned index is the limiting factor for many osteoporosis related managements after fracture. We decided to use this as the primary outcome
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startJan 2014
- Primary completion28 Dec 2017
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ding-Cheng Chan Chan, MD, PhD, Principal investigator, National Taiwan University Hospital Chu-Tung Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194660
- Sponsor's protocol ID
- 201311048RINC
- Status last verified
- Jun 2025
- First submitted
- 16 Jul 2014
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fragility Fracture Liaison Service Project
- ClinicalTrials.gov ID
- NCT02194660
- Acronym / sponsor ID
- 201311048RINC
- Conditions
- Osteoporosis, Fracture
- Keywords
- Fractures Liaison Service, Osteoporosis, Fracture, Medication adherence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 28 Dec 2017 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 18 Jul 2014 (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.
Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and its Beihu Branch (BB).
Method: From Jan., 2014, two related fracture liaison services (FLSs) following the 13 'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan University Hospital (NTUH) health care system. The main hospital (MH) program enrolled patient with 1) new hip fracture 2) newly identified radiographic vertebral fractures or 3) clinical vertebral fractures from both inpatients and outpatients. The Beihu branch (BB) program enrolled only the later two types of patients from outpatients. During the whole study period, two programs planed to enroll 600 fracture patients. Each patient would be assessed at baseline, and every 4 month for at least one year.
Detailed description
Background:The Asia Fracture Gap Taiwan Study (AFGTS) showed that among fragility fracture sufferers, only 1/4 of them underwent bone mineral density (BMD) tests and 1/3 of them received treatments for osteoporosis. Secondary fragility fracture prevention services are needed to improve the care gaps
. Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and its Beihu Branch (BB).
Method: The FLS was designed following the 13 'Capture the Fracture Best Practice Standards'. The National Taiwan University Hospital (NTUH) institutional review board approved the study in Jan., 2014. Patients were eligible to be enrolled into the main hospital (MH) service if they had
- new hip fracture in orthopedic ward
- newly identified radiographic vertebral fractures from plan films in geriatric ward or
- clinical vertebral fractures in outpatient clinics.
Patients in outpatient clinics of BB were eligible to be enrolled if they had (1) clinical vertebral fractures or (2) newly identified asymtomatic radiological vertebral fractures by a routine weekly review of every plan film of thoracic or lumbar spine regardless of the reason for it.They were excluded from the service if they had life expectancy shorter than 2 years of life or not be able to complete study assessments for communication or cognitive problems.
Osteoporosis-related assessments, treatments, consultations on diet, medications, exercise, fall prevention were given mainly by care managers. A system is set up to remind patients to take their medications at home or to return to clinic for regular injections of medications. Follow up assessments included adherence to education instructions, medications, fall and fracture incidences. During the whole study period, we planed to enroll 600 fracture patients. Each patient would be assessed at baseline, and every 4 months last for two years.
Anticipated results:
Establish domestic FLS model and database Publish preliminary results at the 2014 the IOF 5th Regionals Asia Pacific Meeting in Taipei in November.
Participating physicians and care managers will learn new skills in managing osteoporosis patients.
Application for Best Practice Recognition for the IOF Capture the Fracture Campaign
Preliminary results:
We have enrolled 371 eligible patients into FLS services. From the NTUH program, BMD tests were completed within 8 weeks for over 90% of participants. Also, anti-osteoporosis medication (AOMs) were prescribed to about 90% of participants eligible for National Health Insurance reimbursements.
In 2014, National Taiwan University Hospital (NTUH) and its BeiHu Branch (BB) were awarded the gold medal and silver medal accredited best practice programs from the 'Capture the Fracture' campaign from International Osteoporosis Foundation, respectively.
Our preliminary results were presented at annual scientific meeting of the Taiwanese Osteoporosis Association, at Madrid, Spain, and the IOF 5th Regionals Asia Pacific Meeting in Taipei, Taiwan, and the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases, at Milan, Italy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M- main hospital | – | –Patient enrolled in the main hospital |
| B- Beihu branch | – | –Patients enrolled in the Beihu branch |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- new fragility fracture
Key inclusion criteria (7 listed)
- age >=50 years and
- new hip fracture in orthopedic ward
- newly identified radiographic vertebral fractures from plan films in geriatric ward
- clinical vertebral fractures in outpatient clinics Inclusion criteria (Beihu branch, only outpatients)
- age >=50 years and
Key exclusion criteria (4 listed)
- fracture is sufer from trauma or cancer
- atypical fractures
- Life expectancy less than 2 years or can't be assessed for communication or cognitive problems
- patient in other medication clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone Mineral Density test within 8 weeks of enrollments
Time frame: 8 weeks
Capture the fracture campaign provide 13 best practice standards. The above mentioned index is the limiting factor for many osteoporosis related managements after fracture. We decided to use this as the primary outcome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Ding-Cheng Chan Chan, MD, PhD principal investigator
National Taiwan University Hospital Chu-Tung Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Fracture, run by National Taiwan University Hospital at 1 site in Taiwan.
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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Bone Mineral Density test within 8 weeks of enrollments (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2026.