Health ImprOvement Program of Bone in China

Osteoporosis Clinical Trial

Official title:

Health ImprOvement Program of Bone in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906147
• Other study ID #: LYF2021015.
• Status: Recruiting
• Start date: February 27, 2021
• Est. completion date: February 27, 2031

Study information

• Verified date: June 2023
• Source: Second Xiangya Hospital of Central South University
• Contact: zhifeng sheng, doctorate
• Phone: 008613574806523
• Email: shengzhifeng[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: February 27, 2031
• Est. primary completion date: February 27, 2021
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• Regular follow-up
Follow-up of the population was conducted to track the incidence of fractures

Locations

Country	Name	City	State
China	Health Management Center, The Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Occurrence of fracture	Follow-up of the population was conducted to track the incidence of fractures	From 2021 to 2031
Primary	clinical risk factors of osteoporotic fracture	The main clinical risk factors of osteoporotic fracture were collected	From 2021 to 2031