Randomized Fracture Liaison Services

Osteoporosis Fracture Clinical Trial

Official title:

Fracture Liaison Service：A Randomized Control Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03178799
• Other study ID #: 201703023RINC
• Status: Enrolling by invitation
• Start date: June 23, 2017
• Est. completion date: December 31, 2028

Study information

• Verified date: May 2022
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Osteoporosis Fracture
• Osteoporotic Fractures

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteoporosis Medication Adherence Rate at 24 months	Defined at percents of osteoporosis medication use/expected osteoporosis medication prescriptions in 24 months.	24 months