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

Central South University

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis Fracture
• Intervention / Treatment: Behavioral: FRAX

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.

• Study Type: Observational
• Enrollment (Actual): 264

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • The 2nd Xiangya Hospital, Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Postmenopausal women aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Osteoporosis fracture; 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%.	Behavioral: FRAX; 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%.
women without osteoporosis fracture; 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%.	Behavioral: FRAX; 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osteoporosis fracture	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%.	2017years

Collaborators and Investigators

• Sponsor: Central South University

Publications and helpful links

General Publications

• Zhang Z, Ou Y, Sheng Z, Liao E. How to decide intervention thresholds based on FRAX in central south Chinese postmenopausal women. Endocrine. 2014 Mar;45(2):195-7. doi: 10.1007/s12020-013-0076-y. Epub 2013 Oct 22.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: osteoporosis; FRAX; Chinese population
• Additional Relevant MeSH Terms: Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporotic Fractures
• Other Study ID Numbers: Sheng zhifeng

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No