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

Completed

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Other: Fracture evaluation

• Registration Number: NCT01381588
• Lead Sponsor: GlaxoSmithKline

Brief 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.

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 Timeline

• Study Start: 2010-10
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1136

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post menopausal women	Fracture evaluation	Post menopausal women between 50 to 80

Primary Outcome Measures

Name	Time	Method
The prevalence of OVCFs confirmed by history and X-ray	1 day

Secondary Outcome Measures

Name	Time	Method
The prevalence of asymptomatic (or missed) fractures	1 day

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Seoul, Korea, Republic of