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Trial record 4 of 171 for:    "Osteoporosis, Postmenopausal"
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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
History of Changes
  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:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

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
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 May 22, 2013