Last updated: 11/03/2018 17:16:06
The prevalence of osteoporotic vertebral compression fractures (OVCF) in Korean post menopausal womenTOP
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: The prevalence of osteoporotic vertebral compression fractures (OVCF) in Korean post menopausal women
Trial 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The prevalence of OVCFs confirmed by history and X-ray
Timeframe: 1 day
Secondary outcomes:
The prevalence of asymptomatic (or missed) fractures
Timeframe: 1 day
Interventions:
Other: Fracture evaluation
Enrollment:
1136
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Cross-Sectional
Clinical publications:
Not applicable
Medical condition
Osteoporosis, Postmenopausal
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2010 to February 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
50 - 79 years
Accepts healthy volunteers
Yes
- Subjects who were diagnosed post menopausal state
- Subjects over 50 years old
- Subjects who are not confirmed as post menopause state
- Subjects who do not understand the contents of questionnaire
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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 location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2011-22-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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