Anti-osteoporosis Medication Monitoring and Management Service

NCT02194647 | Active Not Recruiting

• 1 other identifier: 201406077RINA
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Fracture

Keywords

Osteoporosis; Medication Monitoring; Education; Adherence; Management

Outcome Measures

Primary Outcomes (1)

• 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

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

Adults treated with anti-osteoporosis medicines (AOMs)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

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

Study Officials

• Ding-Cheng Chan, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 18, 2014
• Study Start: July 1, 2014
• Primary Completion: August 22, 2015
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

TW (1)