OsteoporosisNCT02635022
Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
An observational study of Osteoporosis and Fracture, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Aims: (1) to Establish the FLS services at the National Taiwan University Hospital Jinshan Branch. (2) To establish a anti-osteoporosis medication management service at Jinshan Branch. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis, Fracture
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2015to Dec 2026
- 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 Adults treated with anti-osteoporosis medicines (AOMs)
Who may be able to join
- Age >=50 and one of the below
- New hip fracture in orthopedic ward
- Newly identified radiographic vertebral fractures from plan films in geriatric ward or clinical vertebral fractures in outpatient clinics
- Newly prescribed with AOMs
- Recent change of AOMs
- Poor adherence to AOMs
- Participating physicians feel that the service will benefit the patient in overall osteoporosis and medication managements.
Who cannot join
- Life expectancy less than 2 years or can't be assessed for communication problems
- Atypical fractures
- Patient in other medication clinical trials
- Unwilling to accept the assessment and treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital, Chutung branch
Hsinchu, 31604
Ding-Cheng Chan, MD,PHD, 886-2-23123456 ext. 67786, doctord6226@yahoo.com
Ding-Cheng Chan, MD,PHD
About this study
Official title: Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study in Rural Area
Aims: (1) to Establish the FLS services at the National Taiwan University Hospital Jinshan Branch. (2) To establish a anti-osteoporosis medication management service at Jinshan Branch.
Method: From Aug., 2015, a fracture liaison services (FLSs) following the 13 'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan University Hospital Jinshan Branch health care system. The Jinshan Branch program enrolled patient with 1) new hip fracture 2) newly identified vertebral fractures (radiological or clinical) from both inpatients and outpatients. At the same time, a osteoporosis medication management service is also establish as a complement of FLS to enroll patients on antiosteoporosis medications (AOMs) but not necessary with fracture.
Read more
Participating physicians will select those eligible for services and refer to study coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture, sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic visit, telephone reminder and follow up for patients, and communicate with providers on regular bases.
During the whole study period, the investigators planed to enroll 200 patients (with or without fracture). Each patient would be assessed at baseline, and every 4 months last for two years.
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. In addition, one-year adherence to oral anti-osteoporosis medication (AOMs) was only about 30%. In recent years, efforts have been made to change the delivery of these medications from oral form to injection form every, 3, 6 or 12 months to increase adherence. However, both patients and providers are sometimes confused about the multiple choices. Also, patients may receive extra medications if providers did not keep tract of their previous AOM uses or patients may changes providers. There were urgent needs to provide AOM monitoring and management services to improve cares.
. Aims: (1) to Establish the FLS services at the National Taiwan University Hospital Jinshan Branch. (2) To establish a anti-osteoporosis medication management service at Jinshan Branch.
Method: The FMS was designed following the 13 'Capture the Fracture Best Practice Standards'. The National Taiwan University Hospital (NTUH) institutional review board approved the study in Aug., 2015. Patients were eligible to be enrolled into the FMS part of the study if they had
- Age >=50 and one of the below
- New hip fracture in orthopedic ward
- Newly identified radiographic vertebral fractures from plan films in geriatric ward or clinical vertebral fractures in outpatient clinics
- Newly prescribed with AOMs
- Recent change of AOMs
- Poor adherence to AOMs
- Participating physicians feel that the service will benefit the patient in overall osteoporosis and medication managements.
Exclusion Criteria:
- Life expectancy less than 2 years or can't be assessed for communication problems
- Atypical fractures
- Patient in other medication clinical trials
- Unwilling to accept the assessment and treatment
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 200 patients. Each patient would be assessed at baseline, and every 4 months last for two years.
Anticipated results:
Establish Osteoporosis-related patient database combined with NTUH Participating physicians and care managers will learn new skills in managing osteoporosis patients.
Enhance adherence to AOMs The results published in the International Osteoporosis Conferences
- Conditions
- Osteoporosis, Fracture
- Keywords
- Fracture, Sarcopenia, Osteoporosis, Care management, Medication adherence
- Medical subject headings
- Osteoporosis, Fractures, Bone, Sarcopenia, 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 |
|---|---|---|
| FLS | Patients with new hip fracture or newly identified vertebral fractures | |
| MMS | Patients prescribed with anti-osteoporosis medications but not fit FLS requirements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of medication adherence
Changes of medication adherence for all participants will be assessed at the 4, 8, 12, 18 and 24 months after enrollments. However, the main primary outcome will be set at the adherence at 12 months. If the patient changes medication, all AOMs adherence will be combined.
Specific formulas of medication adherence assessments are as below:
- for oral medications: adherence is defined as: medication taken/ medication prescribed within past 3 months
- for injection medications: adherence is defined as: of injection/ of due injection since baseline or last follow up phone call. Statistics: Simple counts of adherence (%) among all participants.
Measured: 12 MONTHS
Secondary outcomes (1)
The proportion of patients received Bone Mineral Density test within 8 week after enrollments
This outcome is concerned with the percentage of FLS patients received BMD test at the timing (8 week) of when post-fracture assessment is done.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ding-Cheng Chan, MD, PhD, Principal investigator, National Taiwan University Hospital, Chutung branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635022
- Sponsor's protocol ID
- 201506039RIND
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2015
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study in Rural Area
- ClinicalTrials.gov ID
- NCT02635022
- Acronym / sponsor ID
- 201506039RIND
- Conditions
- Osteoporosis, Fracture
- Keywords
- Fracture, Sarcopenia, Osteoporosis, Care management, Medication adherence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 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.
Aims: (1) to Establish the FLS services at the National Taiwan University Hospital Jinshan Branch. (2) To establish a anti-osteoporosis medication management service at Jinshan Branch.
Method: From Aug., 2015, a fracture liaison services (FLSs) following the 13 'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan University Hospital Jinshan Branch health care system. The Jinshan Branch program enrolled patient with 1) new hip fracture 2) newly identified vertebral fractures (radiological or clinical) from both inpatients and outpatients. At the same time, a osteoporosis medication management service is also establish as a complement of FLS to enroll patients on antiosteoporosis medications (AOMs) but not necessary with fracture.
Participating physicians will select those eligible for services and refer to study coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture, sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic visit, telephone reminder and follow up for patients, and communicate with providers on regular bases.
During the whole study period, the investigators planed to enroll 200 patients (with or without fracture). Each patient would be assessed at baseline, and every 4 months last for two years.
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. In addition, one-year adherence to oral anti-osteoporosis medication (AOMs) was only about 30%. In recent years, efforts have been made to change the delivery of these medications from oral form to injection form every, 3, 6 or 12 months to increase adherence. However, both patients and providers are sometimes confused about the multiple choices. Also, patients may receive extra medications if providers did not keep tract of their previous AOM uses or patients may changes providers. There were urgent needs to provide AOM monitoring and management services to improve cares.
. Aims: (1) to Establish the FLS services at the National Taiwan University Hospital Jinshan Branch. (2) To establish a anti-osteoporosis medication management service at Jinshan Branch.
Method: The FMS was designed following the 13 'Capture the Fracture Best Practice Standards'. The National Taiwan University Hospital (NTUH) institutional review board approved the study in Aug., 2015. Patients were eligible to be enrolled into the FMS part of the study if they had
- Age >=50 and one of the below
- New hip fracture in orthopedic ward
- Newly identified radiographic vertebral fractures from plan films in geriatric ward or clinical vertebral fractures in outpatient clinics
- Newly prescribed with AOMs
- Recent change of AOMs
- Poor adherence to AOMs
- Participating physicians feel that the service will benefit the patient in overall osteoporosis and medication managements.
Exclusion Criteria:
- Life expectancy less than 2 years or can't be assessed for communication problems
- Atypical fractures
- Patient in other medication clinical trials
- Unwilling to accept the assessment and treatment
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 200 patients. Each patient would be assessed at baseline, and every 4 months last for two years.
Anticipated results:
Establish Osteoporosis-related patient database combined with NTUH Participating physicians and care managers will learn new skills in managing osteoporosis patients.
Enhance adherence to AOMs The results published in the International Osteoporosis Conferences
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLS | – | –Patients with new hip fracture or newly identified vertebral fractures |
| MMS | – | –Patients prescribed with anti-osteoporosis medications but not fit FLS requirements |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- new fragility fracture Adults treated with anti-osteoporosis medicines (AOMs)
Key inclusion criteria (7 listed)
- Age >=50 and one of the below
- New hip fracture in orthopedic ward
- Newly identified radiographic vertebral fractures from plan films in geriatric ward or clinical vertebral fractures in outpatient clinics
- Newly prescribed with AOMs
- Recent change of AOMs
Key exclusion criteria (4 listed)
- Life expectancy less than 2 years or can't be assessed for communication problems
- Atypical fractures
- Patient in other medication clinical trials
- Unwilling to accept the assessment and treatment
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
Changes of medication adherence
Time frame: 12 MONTHS
Changes of medication adherence for all participants will be assessed at the 4, 8, 12, 18 and 24 months after enrollments. However, the main primary outcome will be set at the adherence at 12 months. If the patient changes medication, all AOMs adherence will be combined. Specific formulas of medication adherence assessments are as below: 1. for oral medications: adherence is defined as: medication taken/ medication prescribed within past 3 months 2. for injection medications: adherence is defined as: of injection/ of due injection since baseline or last follow up phone call. Statistics: Simple counts of adherence (%) among all participants.
1 secondary outcome
The proportion of patients received Bone Mineral Density test within 8 week after enrollments
Time frame: 8 week
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 23 Dec 2025.
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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.
Ding-Cheng Chan, MD, PhD principal investigator
National Taiwan University Hospital, Chutung 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: looking for participants now, as of the sponsor's last update on 23 Dec 2025. 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?
Contact Ding-Cheng Chan, MD, PhD (886-2-23123456 ext. 67786, doctord6226@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of medication adherence (time frame: 12 MONTHS). 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 23 Dec 2025.