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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01381588
First received: June 9, 2011
Last updated: June 30, 2011
Last verified: June 2011
History of Changes
  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: Time Perspective: Cross-Sectional
Official Title: The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The prevalence of OVCFs confirmed by history and X-ray [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The prevalence of asymptomatic (or missed) fractures [ Time Frame: 1 day ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 79 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01381588     History of Changes
Other Study ID Numbers: 114777
Study First Received: June 9, 2011
Last Updated: June 30, 2011
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013