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

Osteoporosis, Postmenopausal Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381588
• Other study ID #: 114777
• Status: Completed
• Phase: N/A
• First received: June 9, 2011
• Last updated: May 15, 2017
• Start date: October 2010
• Est. completion date: February 2011

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1136
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Compression
• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Other:
• Fracture evaluation
DEXA(Dual-energy X-ray absorptiometry), X-ray

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of OVCFs confirmed by history and X-ray		1 day
Secondary	The prevalence of asymptomatic (or missed) fractures		1 day