Health ImprOvement Program of Bone in China

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis
• Intervention / Treatment: Other: Regular follow-up

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: zhifeng sheng, doctorate; Phone Number: 008613574806523; Email: shengzhifeng@csu.edu.cn
• Study Contact Backup: Name: chun yue, doctorate; Phone Number: 008615700733115; Email: yuechun@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Health Management Center, The Second Xiangya Hospital of Central South University
      • Contact: zhifeng sheng, doctorate; Phone Number: 008613574806523; Email: shengzhifeng@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2021
• Primary Completion (Actual): February 27, 2021
• Study Completion (Estimated): February 27, 2031

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: LYF2021015.

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