Randomized Fracture Liaison Services

NCT03178799 | Enrolling By Invitation

• 1 other identifier: 201703023RINC
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis Fracture

Keywords

Fractures; Osteoporosis; Care management; cost-effeciveness; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Osteoporosis Medication Adherence Rate at 24 months

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

  24 months

Study Arms (2)

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). )

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Osteoporotic Fractures; Fractures, Bone; Osteoporosis

Condition Hierarchy (Ancestors)

Wounds and Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ding-Cheng Chan

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 7, 2017
• Study Start: June 23, 2017
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

TW (1)