Geriatric Health Exam Osteoporosis Screening | NCT01934387

Studies
Geriatric Health Exam Osteoporosis Screening

NCT01934387

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Apr 23, 2014Estimated

Enrollment

1,319Actual

Phase

Not provided

Conditions

Osteoporosis
Accidental Falls
Fracture

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Mar 2014Actual

First Submitted Date

Jul 3, 2013

First Submission Date that Met QC Criteria

Aug 29, 2013

First Posted Date

Sep 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2014

Last Update Posted Date

Apr 23, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,319Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	11-month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Adults visitng geraitric health exam clinics.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ding-Cheng Chan, MD, PhD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis
D050723	Fractures, Bone

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided