Anti-osteoporosis Medication Monitoring and Management Service

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02194647

Collaborator

(none)

500

Enrollment

Location

144

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

BACKGROUND:

One-year adherence to oral anti-osteoporosis medication (AOMs) was only about 30%. In recent years, efforts have been made to change the delivery of these medications from oral form to injection form every, 3, 6 or 12 months to increase adherence. However, both patients and providers are sometimes confused about the multiple choices. Also, patients may receive extra medications if providers did not keep tract of their previous AOM uses or patients may changes providers. There were urgent needs to provide AOM monitoring and management services to improve cares.

OBJECTIVES:

To establish a anti-osteoporosis medication management service at National Taiwan University Hospital and its BeiHu Branch.

METHODS:

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. the investigators plan to enroll 500 patients with 18-month follow up for each.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Fracture

Study Design

Study Type:

Observational

Actual Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

Anti-osteoporosis Medication Monitoring and Management Service

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Aug 22, 2015

Anticipated Study Completion Date :

Jul 1, 2026

Outcome Measures

Primary Outcome Measures

medication adherence [18 months]
Medication adherence will be assessed at 4, 8, 12, 18 months after enrollments. Final results will be reported at 18 month. If the patient changes medication, all AOMs adherence will be combined. Specific formula is as below: for oral medications, adherence is defined as # medication taken/ #medication prescribed within past 3 months 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age >=50 and one of the below
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.

Exclusion Criteria:

Life expectancy less than 2 years or can't be assessed for communication problems
patient in our fracture liaison service or other medication clinical trials