Quality of Life(QoL) in Korean Postmenopausal Osteoporosis Patients With Bisphosphonate Treatment (BRAVO)

June 6, 2017 updated by: GlaxoSmithKline
Quality of Life (QoL) in Korean postmenopausal osteoporosis patients with bisphosphonate treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cross-sectional quality of life survey using self-administered OPSAT-QTM questionnaire in Korean postmenopausal osteoporosis patients with bisphosphonate treatment

Study Type

Observational

Enrollment (Actual)

4376

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

According to 2006 national health insurance data, a total of osteoporosis women (ICD-10 code: M81) are about 244,190 in Korea According to recent market research data, 95% of osteoporosis women use bisphosphonate in Korea.

With considering 95% market share of bisphosphonate in osteoporosis market, there are 231,714 Korean osteoporosis women. Applying for 2% extracting fraction in this study, total size of study population are 4,634.

Description

Inclusion Criteria:

  • Who have been diagnosed with postmenopausal osteoporosis by physician Who have received any oral bisphosphonates (weekly or monthly) at least for 2 months to provide answer of OPSAT-QTM questionnaire Who provide informed consent for study participation

Exclusion Criteria:

  • Do not understand the contents of the questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bisphosphonates
Korean postmenopausal osteoporosis patients with bisphosphonate treatment
Other: OPSAT-Q
A linguistically validated Korean version of OPSAT-Q

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean of composite satisfaction score (CSS) of OPSAT-QTM
Time Frame: 0day
0day

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean of subscale satisfaction scores of OPSAT-QTM
Time Frame: oday
oday

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

June 3, 2010

First Submitted That Met QC Criteria

October 21, 2010

First Posted (Estimate)

October 25, 2010

Study Record Updates

Last Update Posted (Actual)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111720

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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