An observational study in Osteoporosis and Fracture, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by National Taiwan University Hospital · Observational
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.
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
Exclusion Criteria:
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
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's planned enrollment of 200 is above the median of 160 across 455 observational studies indexed under Osteoporosis.
Browse Osteoporosis studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
new fragility fracture Adults treated with anti-osteoporosis medicines (AOMs)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with new hip fracture or newly identified vertebral fractures
Patients prescribed with anti-osteoporosis medications but not fit FLS requirements
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: 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.
Time frame: 12 MONTHS
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.
Time frame: 8 week
Started Sep 2015 (actual). Primary completion is estimated for Dec 2026, 135 months after the start.
Of 114 non-industry observational studies under Osteoporosis, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 113. This study's planned 135 months is above that.
Counting every sponsor, half of 125 studies reached it within 51 months; a quarter within 24 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
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