Trial record 4 of 202 for:    Open Studies | "Osteoporosis"

Anti-osteoporosis Medication Monitoring and Management Service

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT02194647
First received: July 16, 2014
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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 12-month follow up for each.


Condition
Osteoporosis
Fracture

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Anti-osteoporosis Medication Monitoring and Management Service

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • medication adherence [ Time Frame: 12months ] [ Designated as safety issue: No ]

    Medication adherence will be assessed at 4, 8, 12 months after enrollments. Final results will be reported at 12 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.



Estimated Enrollment: 500
Study Start Date: July 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults treated with anti-osteoporosis medicines (AOMs)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02194647

Contacts
Contact: Ding-Cheng Chan, MD, PhD 886-2-23123456 ext 67095 doctord6226@yahoo.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Ding-Cheng Chan, MD,PHD    886-2-23123456 ext 67205    doctord6226@yahoo.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ding-Cheng Chan, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02194647     History of Changes
Other Study ID Numbers: 201406077RINA
Study First Received: July 16, 2014
Last Updated: July 21, 2014
Health Authority: Taiwan: Ministry of Health and Welfare

Keywords provided by National Taiwan University Hospital:
Osteoporosis
Medication Monitoring
Education
Adherence
Management

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 16, 2014