- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02635022
Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
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.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ding-Cheng Chan, MD, PhD
- Phone Number: 67786 886-2-23123456
- Email: doctord6226@yahoo.com
Study Locations
-
-
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Hsinchu, Taiwan, 31604
- Recruiting
- National Taiwan University Hospital, Chutung branch
-
Contact:
- Ding-Cheng Chan, MD,PHD
- Phone Number: 67786 886-2-23123456
- Email: doctord6226@yahoo.com
-
Principal Investigator:
- Ding-Cheng Chan, MD,PHD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
12 MONTHS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 week
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ding-Cheng Chan, MD, PhD, National Taiwan University Hospital, Chutung branch
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201506039RIND
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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