NCT04960033

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

29 days

First QC Date

July 2, 2021

Last Update Submit

July 2, 2021

Conditions

Keywords

FRAXosteoporosisChinese population

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

Interventions

FRAXBEHAVIORAL

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%.

Osteoporosis fracturewomen without osteoporosis fracture

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 2nd Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

Location

Related 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.

    PMID: 24146412BACKGROUND

MeSH Terms

Conditions

Osteoporotic FracturesOsteoporosis

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Central South University

Study Record Dates

First Submitted

July 2, 2021

First Posted

July 13, 2021

Study Start

September 1, 2017

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

July 13, 2021

Record last verified: 2021-07

Locations