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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: FLS
Group B: MMS

Trial outcomes

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.

Time frame
12 MONTHS

Secondary outcomes

1

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

This outcome is concerned with the percentage of FLS patients received BMD test at the timing (8 week) of when post-fracture assessment is done.

Time frame
8 week

Other outcomes

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