NCT02194660

Brief Summary

Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and its Beihu Branch (BB). Method: From Jan., 2014, two related fracture liaison services (FLSs) following the 13 'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan University Hospital (NTUH) health care system. The main hospital (MH) program enrolled patient with 1) new hip fracture 2) newly identified radiographic vertebral fractures or 3) clinical vertebral fractures from both inpatients and outpatients. The Beihu branch (BB) program enrolled only the later two types of patients from outpatients. During the whole study period, two programs planed to enroll 600 fracture patients. Each patient would be assessed at baseline, and every 4 month for at least one year.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2017

Completed
8.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

4 years

First QC Date

July 16, 2014

Last Update Submit

May 14, 2024

Conditions

Keywords

Fractures Liaison ServiceOsteoporosisFractureMedication adherence

Outcome Measures

Primary Outcomes (1)

  • Bone Mineral Density test within 8 weeks of enrollments

    Capture the fracture campaign provide 13 best practice standards. The above mentioned index is the limiting factor for many osteoporosis related managements after fracture. We decided to use this as the primary outcome

    8 weeks

Study Arms (2)

M- main hospital

Patient enrolled in the main hospital

B- Beihu branch

Patients enrolled in the Beihu branch

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

new fragility fracture

You may qualify if:

  • age \>=50 years and
  • new hip fracture in orthopedic ward
  • newly identified radiographic vertebral fractures from plan films in geriatric ward
  • age \>=50 years and
  • newly identified radiographic vertebral fractures from plan films
  • clinical vertebral fractures

You may not qualify if:

  • fracture is sufer from trauma or cancer
  • atypical fractures
  • Life expectancy less than 2 years or can't be assessed for communication or cognitive problems
  • patient in other medication clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

OsteoporosisFractures, BoneMedication Adherence

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and InjuriesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Ding-Cheng Chan Chan, MD, PhD

    National Taiwan University Hospital Chu-Tung Branch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2014

First Posted

July 18, 2014

Study Start

January 1, 2014

Primary Completion

December 28, 2017

Study Completion

May 1, 2026

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations