Health ImprOvement Program of Bone in China

• Sponsor: Second Xiangya Hospital of Central South University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05906147
• Collaborator: (none)
• Enrollment: 5,000
• Location: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 41.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Other: Regular follow-up

Study Design

• Study Type: Observational
• Anticipated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Health ImprOvement Program of Bone in China
• Actual Study Start Date: Feb 27, 2021
• Actual Primary Completion Date: Feb 27, 2021
• Anticipated Study Completion Date: Feb 27, 2031

Outcome Measures

Primary Outcome Measures

1. bone mineral density bone mineral density [From 2021 to 2031]

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

2. Occurrence of fracture [From 2021 to 2031]

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

3. clinical risk factors of osteoporotic fracture [From 2021 to 2031]

   The main clinical risk factors of osteoporotic fracture were collected

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 100 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health Management Center, The Second Xiangya Hospital of Central South University	Changsha	Hunan	China	410000

Sponsors and Collaborators

• Second Xiangya Hospital of Central South University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: sheng zhifeng, Director of the Health Management Center of the Second Xiangya Hospital of Central South University, Second Xiangya Hospital of Central South University
• ClinicalTrials.gov Identifier: NCT05906147
• Other Study ID Numbers: LYF2021015.
• First Posted: Jun 15, 2023
• Last Update Posted: Jun 15, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoporosis

Study Results

No Results Posted as of Jun 15, 2023