Randomized Fracture Liaison Services

Fracture Liaison Service：A Randomized Control Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Osteoporosis Fracture

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• 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.

Description

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

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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). )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osteoporosis Medication Adherence Rate at 24 months	Defined at percents of osteoporosis medication use/expected osteoporosis medication prescriptions in 24 months.	24 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Ding-Cheng Chan, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2017
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Osteoporosis; Fractures; Care management; cost-effeciveness
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Metabolic Diseases; Bone Diseases, Metabolic; Nutritional and Metabolic Diseases; Fractures, Bone; Osteoporosis; Osteoporotic Fractures
• Other Study ID Numbers: 201703023RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No