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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01227369
First received: June 3, 2010
Last updated: February 17, 2011
Last verified: February 2011
  Purpose

Quality of Life (QoL) in Korean postmenopausal osteoporosis patients with bisphosphonate treatment


Condition Intervention
Osteoporosis, Postmenopausal
Other: OPSAT-Q

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Quality of Life(QoL) in Korean Postmenopausal Osteoporosis Patients With Bisphosphonate Treatment

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean of composite satisfaction score (CSS) of OPSAT-QTM [ Time Frame: 0day ]

Secondary Outcome Measures:
  • Mean of subscale satisfaction scores of OPSAT-QTM [ Time Frame: oday ]

Enrollment: 4376
Study Start Date: June 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Bisphosphonates
Korean postmenopausal osteoporosis patients with bisphosphonate treatment
Other: OPSAT-Q
A linguistically validated Korean version of OPSAT-Q

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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
  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: NCT01227369

Locations
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01227369     History of Changes
Other Study ID Numbers: 111720
Study First Received: June 3, 2010
Last Updated: February 17, 2011
Health Authority: Korea: Korea Food & Drug Administration

Keywords provided by GlaxoSmithKline:
Bisphosphonates
OPSAT-Q

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014