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

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ClinicalTrials.gov Identifier: NCT01227369
Recruitment Status : Completed
First Posted : October 25, 2010
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease Intervention/treatment
Osteoporosis, Postmenopausal Other: OPSAT-Q

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
Actual Enrollment : 4376 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Quality of Life(QoL) in Korean Postmenopausal Osteoporosis Patients With Bisphosphonate Treatment
Study Start Date : June 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

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



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

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


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

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01227369     History of Changes
Other Study ID Numbers: 111720
First Posted: October 25, 2010    Key Record Dates
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