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NCT Number: NCT02635022

Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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:

    • 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.

Secondary outcomes

  1. The proportion of patients received Bone Mineral Density test within 8 week after enrollments

    Time frame: 8 week

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ding-Cheng Chan, MD, PhD

CONTACT

[email protected]

886-2-23123456 ext. 67786

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study in Rural Area

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2015
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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