Osteoporosis, PostmenopausalBRAVONCT01227369
Quality of Life(QoL) in Korean Postmenopausal Osteoporosis Patients With Bisphosphonate Treatment
An observational study of Osteoporosis, Postmenopausal, run by GlaxoSmithKline at 1 site in South Korea.
Trial summary
Quality of Life (QoL) in Korean postmenopausal osteoporosis patients with bisphosphonate treatment Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- OPSAT-Q
- How many people
- 4,376 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2008to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Do not understand the contents of the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Quality of Life (QoL) in Korean postmenopausal osteoporosis patients with bisphosphonate treatment
Read the detailed description
Cross-sectional quality of life survey using self-administered OPSAT-QTM questionnaire in Korean postmenopausal osteoporosis patients with bisphosphonate treatment
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- OPSAT-Q
- Keywords
- Bisphosphonates, OPSAT-Q
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPSAT-QOther
A linguistically validated Korean version of OPSAT-Q
| Study group | Role | What they receive |
|---|---|---|
| Bisphosphonates | Korean postmenopausal osteoporosis patients with bisphosphonate treatment Receives: Other: OPSAT-Q |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of composite satisfaction score (CSS) of OPSAT-QTM
Measured: 0day
Secondary outcomes (1)
Mean of subscale satisfaction scores of OPSAT-QTM
Measured: oday
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startJun 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 4,376 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227369
- Sponsor's protocol ID
- 111720
- Acronym
- BRAVO
- Status last verified
- Jun 2017
- First submitted
- 3 Jun 2010
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life(QoL) in Korean Postmenopausal Osteoporosis Patients With Bisphosphonate Treatment
- ClinicalTrials.gov ID
- NCT01227369
- Acronym / sponsor ID
- BRAVO / 111720
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- Bisphosphonates, OPSAT-Q
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,376 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 25 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Quality of Life (QoL) in Korean postmenopausal osteoporosis patients with bisphosphonate treatment
Detailed description
Cross-sectional quality of life survey using self-administered OPSAT-QTM questionnaire in Korean postmenopausal osteoporosis patients with bisphosphonate treatment
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bisphosphonates | – | Other: OPSAT-QKorean postmenopausal osteoporosis patients with bisphosphonate treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Do not understand the contents of the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPSAT-QA linguistically validated Korean version of OPSAT-Q | Other | Bisphosphonates |
Primary outcome
Mean of composite satisfaction score (CSS) of OPSAT-QTM
Time frame: 0day
1 secondary outcome
Mean of subscale satisfaction scores of OPSAT-QTM
Time frame: oday
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Postmenopausal, run by GlaxoSmithKline at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of composite satisfaction score (CSS) of OPSAT-QTM (time frame: 0day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2017.