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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01381588
First Posted: June 27, 2011
Last Update Posted: May 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention
Osteoporosis, Postmenopausal Other: Fracture evaluation

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The prevalence of OVCFs confirmed by history and X-ray [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • The prevalence of asymptomatic (or missed) fractures [ Time Frame: 1 day ]

Enrollment: 1136
Study Start Date: October 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Post menopausal women
Post menopausal women between 50 to 80
Other: Fracture evaluation
DEXA(Dual-energy X-ray absorptiometry), X-ray
Other Name: X-ray

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Postmenopausal women
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381588


Locations
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01381588     History of Changes
Other Study ID Numbers: 114777
First Submitted: June 9, 2011
First Posted: June 27, 2011
Last Update Posted: May 16, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Osteoporosis
Fractures, Compression
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Fractures, Bone
Wounds and Injuries