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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04960033
Other study ID # Sheng zhifeng
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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