OsteoporosisNCT01930656
Mobile Device to Help FRAX® Screening
An observational study of Osteoporosis and Fracture, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Fracture
- How many people
- 225 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults visitng geraitric health exam clinics, orthopedic clinic, and endocrinology clinic
Who may be able to join
- age 40-90
- screen high risk from FRAX
Who cannot join
- treated with anti-osteoporosis medications within last 3-12 months (depends on medication types)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Using Mobile Device and the World Health Organization Fracture Risk Assessment Tool (FRAX®) to Assist Osteoporosis Assessment and Management
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.
Read more
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.
Read the detailed 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.
- Conditions
- Osteoporosis, Fracture
- Keywords
- osteoporisis, fracture, risk, cost effectiveness, FRAX, mobile device
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A, B, C | Group A- American cut-point Group B- Translational approach cut-point Group C- Cost-effectiveness cut-point |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of enrollment cases
target 75 in each group, total 225
Measured: in 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Responsible party
- Sponsor
- Investigators
- Ding-Cheng Chan, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930656
- Sponsor's protocol ID
- 201208029RIC
- Status last verified
- Apr 2014
- First submitted
- 3 Jul 2013
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Using Mobile Device and the World Health Organization Fracture Risk Assessment Tool (FRAX®) to Assist Osteoporosis Assessment and Management
- ClinicalTrials.gov ID
- NCT01930656
- Acronym / sponsor ID
- 201208029RIC
- Conditions
- Osteoporosis, Fracture
- Keywords
- osteoporisis, fracture, risk, cost effectiveness, FRAX, mobile device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Study start
- Mar 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A, B, C | – | –Group A- American cut-point Group B- Translational approach cut-point Group C- Cost-effectiveness cut-point |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults visitng geraitric health exam clinics, orthopedic clinic, and endocrinology clinic
Key inclusion criteria (2 listed)
- age 40-90
- screen high risk from FRAX
Key exclusion criteria (1 listed)
- treated with anti-osteoporosis medications within last 3-12 months (depends on medication types)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of enrollment cases
Time frame: in 6 month
target 75 in each group, total 225
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2014.
Related trials for Osteoporosis
Enrolling by invitationPhase 3
Quanduzhong Capsules for Primary Osteoporosis
Primary Osteoporosis
RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
RecruitingObservational study
A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
Osteoporosis, Osteopenia
RecruitingObservational study
Bone Health in Adults With Duchenne Muscular Dystrophy: A Survey on Osteoporosis, Fractures and Treatment.
Duchenne Muscular Dystrophy (DMD)
RecruitingObservational study
REMS vs DXA for Osteoporosis Diagnosis and Fracture Risk Prediction
Osteoporosis Diagnosis, Bone Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ding-Cheng Chan, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Fracture, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of enrollment cases (time frame: in 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2014.