OsteoporosisNCT01934387
Geriatric Health Exam Osteoporosis Screening
An observational study of Osteoporosis and Accidental Falls, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
BACKGROUND: The World Health Organization Fracture Risk Assessment Tool (WHO FRAX®) Taiwanese calculator is freely available on line to help osteoporosis management. However, its clinical utility for improving osteoporosis awareness and patient acceptance has not been validated in Taiwanese population. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Accidental Falls, Fracture
- How many people
- 1,319 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2013to Mar 2014
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Adults visitng geraitric health exam clinics.
Who may be able to join
- Participation in the NTUH GHE program
- Can complete the study questionnaire
- Willingness to join in the researchers
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Osteoporosis Awareness With Fracture Risk Assessments and Management Among Geriatric Health Examination Recipients at National Taiwan University Hospital
BACKGROUND: The World Health Organization Fracture Risk Assessment Tool (WHO FRAX®) Taiwanese calculator is freely available on line to help osteoporosis management. However, its clinical utility for improving osteoporosis awareness and patient acceptance has not been validated in Taiwanese population.
OBJECTIVES: This 11-month FRAX® based screening and referral program enrolling older adults participating in the geriatric health examinations (GHEs) at the National Taiwan University Hospital (NTUH) aiming at determine the patient acceptance of the tool and the program and to improve patient awareness in osteoporosis. The second aim is to look for the recommendations from the participating physicians to improve the FRAX® -based osteoporosis management model.
Read more
METHODS: The NTUH GHE program is a two stage process to serve 3,000 older adults collecting annually from Mar. to Dec. Subjects will be enrolled to the current study at the stage 1 GHE visits after informed consent. Baseline questionnaires including the FRAX® tools will be distributed and expected to be returned at the stage 2 visits. Research assistants will calculate the 10-year predicted fracture risks for the participants during the waiting periods and present the numbers to the GHE physicians. High risks individuals will be referred to general geriatric clinic for further managements. All participants will be provided with osteoporosis and fracture educational material. Patient acceptance and awareness will be assessed. The study is to be started from Feb., to Oct., 2013 to enroll roughly 1,800 older adults assuming refusal rate about 40%.
Qualitative interviews will be used to obtain recommendations from study geriatricians in Jul., 2013 to optimize the FRAX® based screening and management model.
Read the detailed description
ANTICIPATED RESULTS:
To estimate the 10 year fracture risks for GHE participants. To understand the acceptance of this FRAX® based model from GHE participants and the impacts on patient osteoporosis awareness.
To calculate the economic benefits of this model on geriatric outpatient service.
To obtain recommendations from study geriatricians to optimize the FRAX® based model for further disseminations.
- Conditions
- Osteoporosis, Accidental Falls, Fracture
- Keywords
- World Health Organization Fracture Risk Assessment Tool, Osteoporosis, Aged, Prevention, Fracture, FRAX
- Medical subject headings
- Osteoporosis, Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of elderly transfer to geriatric department
The study expected to collect 1,800 cases that using the assessment tool (FRAX) for osteoporosis screening. The primary outcomes were 10-year probability of major osteoporotic fracture and 10-year probability of hip fracture.Investigators want to know what the percentages of elderly in high risk need to be transfer to geriatric department for further treatment.
Measured: 11-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionMar 2014
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
- 1,319 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ding-Cheng Chan, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934387
- Sponsor's protocol ID
- 201205110RIC
- 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
- Increasing Osteoporosis Awareness With Fracture Risk Assessments and Management Among Geriatric Health Examination Recipients at National Taiwan University Hospital
- ClinicalTrials.gov ID
- NCT01934387
- Acronym / sponsor ID
- 201205110RIC
- Conditions
- Osteoporosis, Accidental Falls, Fracture
- Keywords
- World Health Organization Fracture Risk Assessment Tool, Osteoporosis, Aged, Prevention, Fracture, FRAX
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,319 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Sep 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 World Health Organization Fracture Risk Assessment Tool (WHO FRAX®) Taiwanese calculator is freely available on line to help osteoporosis management. However, its clinical utility for improving osteoporosis awareness and patient acceptance has not been validated in Taiwanese population.
OBJECTIVES: This 11-month FRAX® based screening and referral program enrolling older adults participating in the geriatric health examinations (GHEs) at the National Taiwan University Hospital (NTUH) aiming at determine the patient acceptance of the tool and the program and to improve patient awareness in osteoporosis. The second aim is to look for the recommendations from the participating physicians to improve the FRAX® -based osteoporosis management model.
METHODS: The NTUH GHE program is a two stage process to serve 3,000 older adults collecting annually from Mar. to Dec. Subjects will be enrolled to the current study at the stage 1 GHE visits after informed consent. Baseline questionnaires including the FRAX® tools will be distributed and expected to be returned at the stage 2 visits. Research assistants will calculate the 10-year predicted fracture risks for the participants during the waiting periods and present the numbers to the GHE physicians. High risks individuals will be referred to general geriatric clinic for further managements. All participants will be provided with osteoporosis and fracture educational material. Patient acceptance and awareness will be assessed. The study is to be started from Feb., to Oct., 2013 to enroll roughly 1,800 older adults assuming refusal rate about 40%.
Qualitative interviews will be used to obtain recommendations from study geriatricians in Jul., 2013 to optimize the FRAX® based screening and management model.
Detailed description
ANTICIPATED RESULTS:
To estimate the 10 year fracture risks for GHE participants. To understand the acceptance of this FRAX® based model from GHE participants and the impacts on patient osteoporosis awareness.
To calculate the economic benefits of this model on geriatric outpatient service.
To obtain recommendations from study geriatricians to optimize the FRAX® based model for further disseminations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Adults visitng geraitric health exam clinics.
Key inclusion criteria (3 listed)
- Participation in the NTUH GHE program
- Can complete the study questionnaire
- Willingness to join in the researchers
Key exclusion criteria (1 listed)
- NA
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
Percentages of elderly transfer to geriatric department
Time frame: 11-month
The study expected to collect 1,800 cases that using the assessment tool (FRAX) for osteoporosis screening. The primary outcomes were 10-year probability of major osteoporotic fracture and 10-year probability of hip fracture.Investigators want to know what the percentages of elderly in high risk need to be transfer to geriatric department for further treatment.
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.
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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 Accidental Falls, 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 3 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?
Percentages of elderly transfer to geriatric department (time frame: 11-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.