Osteoporosis, PostmenopausalTOPNCT01381588
The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women
An observational study of Osteoporosis, Postmenopausal, run by GlaxoSmithKline at 1 site in South Korea.
Trial summary
This is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including GHs(general hospitals) and clinics will be enrolled. Read more about this study
- Who is it for?
- Ages 50 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Fracture evaluation
- How many people
- 1,136 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Feb 2011
- 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 50 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postmenopausal women
Who may be able to join
- Subjects who were diagnosed post menopausal state
- Subjects over 50 years old
- The Definition of Post Menopause Women : Women whose last menstruation was over 12months ago
- Subjects who visit orthopedic surgery
- Subjects who have informed consents
Who cannot join
- Subjects who are not confirmed as post menopause state
- Subjects who do not understand the contents of questionnaire
- Subjects over 80 years old
- Subjects experienced any high energy fracture (including trash and fall) within 3 months.
- Subjects experienced a fracture except vertebral fracture within 6 months
- Unable to evaluate L-spine BMD over 2 levels because of spinal fracture or instrumentation for L-spine 1-4.
- Unable to evaluate BMD at both femur because of hip fracture or instrumentation.
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including GHs(general hospitals) and clinics will be enrolled.
Read the detailed description
This is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including GHs(general hospitals) and clinics will be enrolled. They will take the evaluation of spine X-ray and answer to a few questions. Their medical record will be reviewed and relevant clinical findings will be collected.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Fracture evaluation
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture evaluationOther
Also called X-ray
DEXA(Dual-energy X-ray absorptiometry), X-ray
| Study group | Role | What they receive |
|---|---|---|
| Post menopausal women | Post menopausal women between 50 to 80 Receives: Other: Fracture evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of OVCFs confirmed by history and X-ray
Measured: 1 day
Secondary outcomes (1)
The prevalence of asymptomatic (or missed) fractures
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startOct 2010
- Primary completionFeb 2011
- Study completionFeb 2011
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
- 1,136 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
- NCT01381588
- Sponsor's protocol ID
- 114777
- Acronym
- TOP
- Status last verified
- May 2017
- First submitted
- 9 Jun 2011
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women
- ClinicalTrials.gov ID
- NCT01381588
- Acronym / sponsor ID
- TOP / 114777
- Conditions
- Osteoporosis, Postmenopausal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,136 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 27 Jun 2011 (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.
This is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including GHs(general hospitals) and clinics will be enrolled.
Detailed description
This is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including GHs(general hospitals) and clinics will be enrolled. They will take the evaluation of spine X-ray and answer to a few questions. Their medical record will be reviewed and relevant clinical findings will be collected.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post menopausal women | – | Other: Fracture evaluationPost menopausal women between 50 to 80 |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women
Key inclusion criteria (5 listed)
- Subjects who were diagnosed post menopausal state
- Subjects over 50 years old
- The Definition of Post Menopause Women : Women whose last menstruation was over 12months ago
- Subjects who visit orthopedic surgery
- Subjects who have informed consents
Key exclusion criteria (7 listed)
- Subjects who are not confirmed as post menopause state
- Subjects who do not understand the contents of questionnaire
- Subjects over 80 years old
- Subjects experienced any high energy fracture (including trash and fall) within 3 months.
- Subjects experienced a fracture except vertebral fracture within 6 months
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 |
|---|---|---|
| Fracture evaluationAlso: X-rayDEXA(Dual-energy X-ray absorptiometry), X-ray | Other | Post menopausal women |
Primary outcome
The prevalence of OVCFs confirmed by history and X-ray
Time frame: 1 day
1 secondary outcome
The prevalence of asymptomatic (or missed) fractures
Time frame: 1 day
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 16 May 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 5 inclusion and 7 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 16 May 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?
The prevalence of OVCFs confirmed by history and X-ray (time frame: 1 day). 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 16 May 2017.