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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01381588
Date of registration: 09/06/2011
Prospective Registration: No
Primary sponsor: GlaxoSmithKline
Public title: The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women TOP
Scientific title: The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women
Date of first enrolment: October 2010
Target sample size: 1136
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01381588
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Korea, Republic of
Contacts
Name:     GSK Clinical Trials
Address: 
Telephone:
Email:
Affiliation:  GlaxoSmithKline
Key inclusion & 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.



Age minimum: 50 Years
Age maximum: 79 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Osteoporosis, Postmenopausal
Intervention(s)
Other: Fracture evaluation
Primary Outcome(s)
The prevalence of OVCFs confirmed by history and X-ray [Time Frame: 1 day]
Secondary Outcome(s)
The prevalence of asymptomatic (or missed) fractures [Time Frame: 1 day]
Secondary ID(s)
114777
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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