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

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ClinicalTrials.gov Identifier: NCT01381588
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Osteoporosis, Postmenopausal Other: Fracture evaluation

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 Type : Observational
Actual Enrollment : 1136 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women
Study Start Date : October 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Group/Cohort Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
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.

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01381588     History of Changes
Other Study ID Numbers: 114777
First Posted: June 27, 2011    Key Record Dates
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
Metabolic Diseases
Fractures, Bone
Wounds and Injuries