Geriatric Health Exam Osteoporosis Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01934387
Recruitment Status : Completed
First Posted : September 4, 2013
Last Update Posted : April 23, 2014
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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.

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.

Condition or disease
Osteoporosis Accidental Falls Fracture

Detailed Description:


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 Type : Observational
Actual Enrollment : 1319 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Increasing Osteoporosis Awareness With Fracture Risk Assessments and Management Among Geriatric Health Examination Recipients at National Taiwan University Hospital
Study Start Date : March 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults visitng geraitric health exam clinics.

Inclusion Criteria:

  • Participation in the NTUH GHE program
  • Can complete the study questionnaire
  • Willingness to join in the researchers

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01934387

National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Ding-Cheng Chan, MD, PhD National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital Identifier: NCT01934387     History of Changes
Other Study ID Numbers: 201205110RIC
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014

Keywords provided by National Taiwan University Hospital:
World Health Organization Fracture Risk Assessment Tool

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases