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The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women (TOP)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01381588
First received: June 9, 2011
Last updated: June 30, 2011
Last verified: June 2011
History of Changes

June 9, 2011
June 30, 2011
October 2010
February 2011   (final data collection date for primary outcome measure)
The prevalence of OVCFs confirmed by history and X-ray [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01381588 on ClinicalTrials.gov Archive Site
The prevalence of asymptomatic (or missed) fractures [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women
The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women

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.

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.
Observational
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

Postmenopausal women
Osteoporosis, Postmenopausal
Other: Fracture evaluation
DEXA(Dual-energy X-ray absorptiometry), X-ray
Other Name: X-ray
Post menopausal women
Post menopausal women between 50 to 80
Intervention: Other: Fracture evaluation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1136
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Female
50 Years to 79 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01381588
114777
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP