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OpenTrials
Completed

NCT Number: NCT01381588

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.

Completed

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Key information

Age range

50 year–79 year

Sex eligibility

Female

Study type

Observational

Primary location

GSK Investigational Site

Seoul, 120-752, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fracture evaluation

Other

DEXA(Dual-energy X-ray absorptiometry), X-ray

Other names: X-ray

Primary outcomes

  1. The prevalence of OVCFs confirmed by history and X-ray

    Time frame: 1 day

Secondary outcomes

  1. The prevalence of asymptomatic (or missed) fractures

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Acronym: TOP

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 27, 2011
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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