Fragility Fracture Liaison Service Project

Osteoporosis Clinical Trial

Official title:

Fragility Fracture Liaison Service Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02194660
• Other study ID #: 201311048RINC
• Status: Active, not recruiting
• Start date: January 2014
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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) 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.

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

1. new hip fracture in orthopedic ward

2. newly identified radiographic vertebral fractures from plan films in geriatric ward or

3. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: May 2026
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria: (Main hospital)

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone
• Osteoporosis

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 weeks