Anti-osteoporosis Medication Monitoring and Management Service

Osteoporosis Clinical Trial

Official title:

Anti-osteoporosis Medication Monitoring and Management Service

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02194647
• Other study ID #: 201406077RINA
• Status: Active, not recruiting
• Start date: July 2014
• Est. completion date: July 1, 2026

Study information

• Verified date: July 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: July 1, 2026
• Est. primary completion date: August 22, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fracture
• Osteoporosis

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	medication adherence	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.	18 months