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Evaluating Fracture Risk Assessment Tools (FRAX) From Different Regions in Central South Chinese Postmenopausal Women

Central South University

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04960033
Enrollment
264
Registered
2021-07-13
Start date
2017-09-01
Completion date
2017-09-30
Last updated
2021-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis Fracture

Keywords

FRAX, osteoporosis, Chinese population

Brief summary

We evaluated fracture risk assessment tools (FRAXs) from different regions in Chinese postmenopausal women.

Detailed description

This cross-sectional study recruited 264 postmenopausal women aged ≥50 years in September 2017. Basic information, general condition, history of illness, family history, and clinical risk factors were evaluated via a questionnaire. All subjects underwent a bone mineral density examination of the femur and lumbar spine and thoracolumbar spinal X-ray. The 10-year major osteoporotic fracture (MOF) and hip fracture (HF) risks were calculated using FRAXs from mainland China, Hong Kong, Taiwan, and Asia-America. All data were analyzed using SPSS 17.0. Sensitivity, specificity, and likelihood ratio were used to compare the effectiveness of each FRAX.

Interventions

BEHAVIORALFRAX

The 10-year MOF probability and the 10-year HF probability were calculated using the FRAXs of different regions (mainland China, Hong Kong, Taiwan, and Asia-America). Subjects were deemed as high-risk for osteoporotic fracture if the 10-year probability of MOF was ≥20% or the 10-year probability of HF was ≥3%.

Sponsors

Central South University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Postmenopausal women aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017. Menopause was defined as the absence of menstrual cycles for at least one year. All subjects were noninstitutionalized and in good health.

Exclusion criteria

* The criteria for exclusion were morphological abnormalities or skeletal distortions that prohibited either clinical measurements or morphometric assessments of skeletal radiographs.

Design outcomes

Primary

MeasureTime frameDescription
Osteoporosis fracture2017yearsThe 10-year MOF probability and the 10-year HF probability were calculated using the FRAXs of different regions (mainland China, Hong Kong, Taiwan, and Asia-America). Subjects were deemed as high-risk for osteoporotic fracture if the 10-year probability of MOF was ≥20% or the 10-year probability of HF was ≥3%.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026