NCT01227369

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,376

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

1.4 years

First QC Date

June 3, 2010

Last Update Submit

June 6, 2017

Conditions

Osteoporosis, Postmenopausal

Keywords

BisphosphonatesOPSAT-Q

Outcome Measures

Primary Outcomes (1)

  • Mean of composite satisfaction score (CSS) of OPSAT-QTM

    0day

Secondary Outcomes (1)

  • Mean of subscale satisfaction scores of OPSAT-QTM

    oday

Study Arms (1)

Bisphosphonates

Korean postmenopausal osteoporosis patients with bisphosphonate treatment

Other: OPSAT-Q

Interventions

OPSAT-QOTHER

A linguistically validated Korean version of OPSAT-Q

Bisphosphonates

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Do not understand the contents of the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2010

First Posted

October 25, 2010

Study Start

June 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

June 7, 2017

Record last verified: 2017-06

Locations

KR(1)