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

Osteoporosis Fracture Clinical Trial

Official title:

Central South University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04960033
• Other study ID #: Sheng zhifeng
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: July 2021
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Osteoporosis Fracture
• Osteoporotic Fractures

Intervention

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%.

Locations

Country	Name	City	State
China	The 2nd Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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