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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03178799
Other study ID # 201703023RINC
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 23, 2017
Est. completion date December 31, 2028

Study information

Verified date May 2024
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


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
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