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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01227369
First Posted: October 25, 2010
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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: Observational Model: Other
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01227369     History of Changes
Other Study ID Numbers: 111720
First Submitted: June 3, 2010
First Posted: October 25, 2010
Last Update Posted: June 7, 2017
Last Verified: June 2017

Keywords provided by GlaxoSmithKline:
Bisphosphonates
OPSAT-Q

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