NCT05906147

Brief Summary

Fracture risk factors have long been identified as key factors in osteoporosis and fragility fractures. The WHO recommended Fracture risk assessmenttool (FRAX) applies clinical risk factors to assess the absolute risk of osteoporotic fractures in each individual. Our preliminary study suggests that FRAX estimates may underestimate the risk of fractures in the Chinese population. In order to optimize the risk prediction model of osteoporotic fractures, a treatment threshold and its optimal cutting point were initially established based on the data of the health management Center of the Second Xiangya Hospital of Central South University.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
59mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Feb 2021Feb 2031

Study Start

First participant enrolled

February 27, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
7.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2031

Expected
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

Same day

First QC Date

June 7, 2023

Last Update Submit

June 7, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • bone mineral density bone mineral density

    Bone mineral density (BMD) data measured by dual-energy X-ray absorptiometry were collected from patients over 40 years old

    From 2021 to 2031

  • Occurrence of fracture

    Follow-up of the population was conducted to track the incidence of fractures

    From 2021 to 2031

  • clinical risk factors of osteoporotic fracture

    The main clinical risk factors of osteoporotic fracture were collected

    From 2021 to 2031

Interventions

Follow-up of the population was conducted to track the incidence of fractures

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Dual-energy X-ray bone mineral density measurement was performed in the health management center of our hospital in the physical examination subjects over 40 years old

You may qualify if:

  • Dual-energy X-ray bone mineral density measurement was performed in the health management center of our hospital in the physical examination subjects over 40 years old. Have independent civil capacity and agree to participate, and sign informed consent

You may not qualify if:

  • Under 40 years of age, Patients who had undergone hip replacement or lumbar surgery and could not perform dual-energy X-ray BMD testing; Patients who have been treated with effective anti-osteoporosis drugs or have a history of malignant tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Management Center, The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

zhifeng sheng, doctorate

CONTACT

chun yue, doctorate

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Health Management Center of the Second Xiangya Hospital of Central South University

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 15, 2023

Study Start

February 27, 2021

Primary Completion

February 27, 2021

Study Completion (Estimated)

February 27, 2031

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations