Mobile Device to Help FRAX® Screening

Osteoporosis Clinical Trial

Official title:

The Effectiveness of Using Mobile Device and the World Health Organization Fracture Risk Assessment Tool (FRAX®) to Assist Osteoporosis Assessment and Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930656
• Other study ID #: 201208029RIC
• Status: Completed
• Phase: N/A
• First received: July 3, 2013
• Last updated: April 22, 2014
• Start date: March 2013
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

Background: The Taiwanese FRAX® (Fracture Risk Assessment Tool) calculator is available online for clinical use. Our Taiwanese Osteoporosis Clinical Treatment Guidelines suggests using the American high risk cut-points for considering treatment but also suggests deriving domestic cut-points from cost-effective approach. Establishing cost-effective domestic cut-points for policy suggestions coupled with mobile devices with wireless access would potentially increase the usage of FRAX® tool.

Objectives: 1) Using literature review to establish cost-effectiveness FRAX® cut-points. 2) To assess the effectiveness of mobile devices assisted FRAX® tool based osteoporosis diagnostic and management model. 3) To provide FRAX® based reimbursement policy suggestions.

Methods: 1) Investigators will use FRAX®, cost-effectiveness and other key words to search Pubmed and international osteoporosis guidelines to better understand the clinical applications of FRAX® in other countries. Investigators will also search epidemiological data for osteoporosis, facture, quality of life and cost to establish domestic cost-effeteness, and translational approach FRAX® cut-points. 2) Three targeting populations from National Taiwan University Hospital (NTUH) are selected for prospective study (Group A: geriatric health exam clinics with American cut-points, group B: orthopedic clinics with translational approach cut-points and group C: endocrine clinics with cost-effectiveness cut-points,). A mobile device with app application coupled with the FRAX® tool is used by a trained research assistant during clinic waiting periods to screen and enroll high risk (75 from each clinic) adults with informed consents. Participants are referred to geriatric clinics for systemic osteoporosis diagnoses and managements. Percentage of participants that meet the current NHI medication reimbursement regulation and percentage of self-pay medications are calculated. Analysis is stratified by age and gender. 3) The impacts of 3 different cut-points on increment NHI reimbursement are estimated. An osteoporosis expert group meeting is to be held for FRAX® based osteoporosis medication reimbursement modifications to the NHI and the Department of Health.

Expected Outcomes: 1) To establish the mobile device assisted FRAX® based osteoporosis screening and management model. 2) Base on the study results and expert consensus, investigators will provide policy suggestions of FRAX® based reimbursement modifications.

Description:

This is an observational study. The study outcomes might base on clinical physician opnions to provide policy suggestion of FRAX® at which cut-point is considering for treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• age 40-90

• screen high risk from FRAX

Exclusion Criteria:

• treated with anti-osteoporosis medications within last 3-12 months (depends on medication types)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fracture
• Osteoporosis

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Department of Health, Executive Yuan, R.O.C. (Taiwan)

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of enrollment cases	target 75 in each group, total 225	in 6 month	No