Last updated: 11/03/2018 17:16:06

The prevalence of osteoporotic vertebral compression fractures (OVCF) in Korean post menopausal womenTOP

GSK study ID
114777
See study documents
Clinicaltrials.gov ID
NCT01381588
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: The prevalence of osteoporotic vertebral compression fractures (OVCF) in Korean post menopausal women
Trial 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The prevalence of OVCFs confirmed by history and X-ray

Timeframe: 1 day

Secondary outcomes:

The prevalence of asymptomatic (or missed) fractures

Timeframe: 1 day

Interventions:
  • Other: Fracture evaluation
    • Enrollment:
    1136
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Cross-Sectional
    Clinical publications:
    Not applicable
    Medical condition
    Osteoporosis, Postmenopausal
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    October 2010 to February 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    50 - 79 years
    Accepts healthy volunteers
    Yes
    • Subjects who were diagnosed post menopausal state
    • Subjects over 50 years old
    • Subjects who are not confirmed as post menopause state
    • Subjects who do not understand the contents of questionnaire
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Seoul, South Korea, 120-752
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2011-22-02

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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