Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study

NCT02635022 | Recruiting

• 1 other identifier: 201506039RIND
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Aims: (1) to Establish the FLS services at the National Taiwan University Hospital Jinshan Branch. (2) To establish a anti-osteoporosis medication management service at Jinshan Branch. Method: From Aug., 2015, a fracture liaison services (FLSs) following the 13 'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan University Hospital Jinshan Branch health care system. The Jinshan Branch program enrolled patient with 1) new hip fracture 2) newly identified vertebral fractures (radiological or clinical) from both inpatients and outpatients. At the same time, a osteoporosis medication management service is also establish as a complement of FLS to enroll patients on antiosteoporosis medications (AOMs) but not necessary with fracture. Participating physicians will select those eligible for services and refer to study coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture, sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic visit, telephone reminder and follow up for patients, and communicate with providers on regular bases. During the whole study period, the investigators planed to enroll 200 patients (with or without fracture). Each patient would be assessed at baseline, and every 4 months last for two years.

Conditions

Osteoporosis; Fracture

Keywords

Fracture; Sarcopenia; Osteoporosis; Care management; Medication adherence

Outcome Measures

Primary Outcomes (1)

• Changes of medication adherence

  Changes of medication adherence for all participants will be assessed at the 4, 8, 12, 18 and 24 months after enrollments. However, the main primary outcome will be set at the adherence at 12 months. If the patient changes medication, all AOMs adherence will be combined. Specific formulas of medication adherence assessments are as below: 1. for oral medications: adherence is defined as: medication taken/ medication prescribed within past 3 months 2. for injection medications: adherence is defined as: of injection/ of due injection since baseline or last follow up phone call. Statistics: Simple counts of adherence (%) among all participants.

  12 MONTHS

Secondary Outcomes (1)

• The proportion of patients received Bone Mineral Density test within 8 week after enrollments

  8 week

Study Arms (2)

FLS

Patients with new hip fracture or newly identified vertebral fractures

MMS

Patients prescribed with anti-osteoporosis medications but not fit FLS requirements

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

new fragility fracture Adults treated with anti-osteoporosis medicines (AOMs)

You may qualify if:

• Age \>=50 and one of the below
• New hip fracture in orthopedic ward
• Newly identified radiographic vertebral fractures from plan films in geriatric ward or clinical vertebral fractures in outpatient clinics
• Newly prescribed with AOMs
• Recent change of AOMs
• Poor adherence to AOMs
• Participating physicians feel that the service will benefit the patient in overall osteoporosis and medication managements.

You may not qualify if:

• Life expectancy less than 2 years or can't be assessed for communication problems
• Atypical fractures
• Patient in other medication clinical trials
• Unwilling to accept the assessment and treatment

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, Chutung branch

Hsinchu, 31604, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone; Sarcopenia; Medication Adherence

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ding-Cheng Chan, MD, PhD

  National Taiwan University Hospital, Chutung branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ding-Cheng Chan, MD, PhD

CONTACT

886-2-23123456; doctord6226@yahoo.com

Study Design

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

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 18, 2015
• Study Start: September 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

TW (1)