CClinicalTrials.gg
Enrolling by invitationNCT03178799Updated May 18, 2026

Randomized Fracture Liaison Services

An observational study in Osteoporosis Fracture, sponsored by National Taiwan University Hospital. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
400
Ages
50 Years to 100 Years
Sex
All
01

Study summary

Aims: To compare clinical outcomes for patients under FLS and usual care at the NTUH MH and BB.

Method: Four hundred subjects with new hip fracture or newly identified vertebral fracture are randomly assigned into FLS and usual care (UC). FLS subjects received osteoporosis-related assessments, treatments, consultations on diet, medications, exercise, fall preventions given mainly by care managers with followed up telephone call at 4, 8, 12, 18, 24 months then annually for up to 10 years. Care managers will perform baseline assessments and follow them by telephone annually for up to 10 years for UC subjects. Major outcomes include bone mineral density assessment rate, calcium, vitamin D, and osteoporosis medication initiation and adherence rate, fall and fracture incidences, mortality, and healthcare resource utilizations.

Read the detailed description

Background: First fragility fracture increased risk for further fracture for 2-4 folds. However, most fracture sufferers did not receive secondary prevention for osteoporosis to decrease future fracture risks. Since 2014, the National Taiwan University Hospital (NTUH) Healthcare system established fracture liaison services and were certified as gold (main hospital, MH) and silver (Beihu branch, BB) medal for best practices. Our preliminary results showed that compared with national average data, hip fracture patients under FLS may have lower mortality rate. However, randomized control trial (RCT) is still needed to confirm results from observational studies.

Aims: to compare clinical outcomes for patients under FLS and usual care at the NTUH MH and BB.

Method: Four hundred subjects with new hip fracture or newly identified vertebral fracture are randomly assigned into FLS and usual care (UC). FLS subjects received osteoporosis-related assessments, treatments, consultations on diet, medications, exercise, fall preventions given mainly by care managers with followed up telephone call at 4, 8, 12, 18, 24 months then annually for up to 10 years. Care managers will perform baseline assessments and follow them by telephone annually for up to 10 years for UC subjects. Major outcomes include bone mineral density assessment rate, calcium, vitamin D, and osteoporosis medication initiation and adherence rate, fall and fracture incidences, mortality, and healthcare resource utilizations.

Anticipated results: Provide evidence on benefit of FLS in RCT on osteoporosis evaluation, medication initiation, mediation adherence, calcium, vitamin D, protein, exercise adherence, fall, re-fracture, mortality and other outcomes.

02

Conditions studied

  • Osteoporosis Fracture

Keywords

  • Fractures
  • Osteoporosis
  • Care management
  • cost-effeciveness
  • Randomized controlled trial
03

Who can participate

Ages eligible
50 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Four hundred subjects with new hip fracture or newly identified vertebral fracture are randomly assigned into FLS and usual care (UC). FLS subjects received osteoporosis-related assessments, treatments, consultations on diet, medications, exercise, fall preventions given mainly by care managers with followed up telephone call at 4, 8, 12, 18, 24 months then annually for up to 10 years. Care managers will perform baseline assessments and follow them by telephone annually for up to 10 years for UC subjects.

Inclusion criteria

  • Age>=50
  • New hip fracture from orthopedic ward
  • Newly identified vertebral fracture (either morphological or clinical)/ old hip fracture without osteoporosis treatment referred by team physicians either inpatients or outpatients
  • Willing to accept 10 years of follow-ups.

Exclusion criteria

Exclusion criteria

  • Traumatic or pathologic fractures
  • Atypical femoral shaft fracture
  • Participating in other medication intervention trials
  • Less than 2 years of life expectancy judged by team physicians
  • Incapable of accepting evaluation for cognitive, communication, and physical problems judged by team physicians or coordinators.
04

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • FLS

    Fracture Liaison Service (Care managers based coordination service for fragility fracture patients with followed up telephone call at 4, 8, 12, 18, 24 months then annually for up to 10 years (to 2028).)

  • UC

    usual care (Care managers will perform baseline assessments and follow them by telephone annually for up to 10 years (to 2028). )

05

What researchers measure

Primary outcomes

  1. Osteoporosis Medication Adherence Rate at 24 months

    Defined at percents of osteoporosis medication use/expected osteoporosis medication prescriptions in 24 months.

    Time frame: 24 months

06

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 10002, Taiwan
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03178799
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jun 7, 2017
Start date
Jun 23, 2017
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
May 18, 2026

Study contacts

Ding-Cheng Chan
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion