A Prospective Cohort Study:Forecast Fracture Risk With a Serum Marker of Type 2 Diabetes in Guangzhou Community

Terminated

• Conditions: Type 2 Diabetes Mellitus and Fragility Fractures

• Registration Number: NCT03456271
• Lead Sponsor: Zhujiang Hospital

Brief Summary

The objective of this study is to find out the biochemical markers which have independent predictive value of fragility fractures risk with Type 2 diabetes in Guangzhou community and evaluate bone strength better and increase the ability of recognizing fracture risk through following-up visits the bone metabolism index like esRAGE-to-pentosidine ratio of the petients with type 2 diabetes and osteoporosis,compared with the classical fracture risk assessment instrument.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-03-06
• Study First Posted: 2018-03-07
• Status Verified: 2021-01
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-31
• Last Update Submitted: 2022-03-06
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• (1) aged 18-65 years; (2) patients were diagnosed with type 2 diabetes based on the definition of diabetes of WHO in 1999.

Exclusion Criteria

• 1. type 1 diabetes and other specific types of diabetes; 2. diabetes related acute complications like diabetic ketoacidosis and hyperglycemic hyperosmolar status. 3. had used drugs that is known to have effect on bone(like active vitamin D, bisphosphonate, calcitonin, estrogen receptor modulators, estrogen, thiazolidinediones); 4. suffer from diseases that is known to have effect on bone (hyperthyroidism, hypothyroidism, hyperparathyroidism, hypoparathyroidism,cushing syndrome,chronic renal failure,renal tubular acidosis,osteoporosis after gastrectomy,osteoporosis caused by liver disease,rheumatoid disease,osteoporosis induced by gastrointestinal absorption dysfunction); 5. disuse osteoporosis; 6. cannot be exposure to sunlight due to skin diseases; 7. use glucocorticoids for over 3 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fracture	3 years	the participants happen to fracture

Trial Locations

Locations (5)

Tianhe Community; 🇨🇳 Guangzhou, Guangdong, China

Haizhu Changgang Community; 🇨🇳 Guangzhou, Guangdong, China

Zhujiang Hospital; 🇨🇳 Guangzhou, Guangdong, China

Baiyun Community Taihe Town; 🇨🇳 Guangzhou, Guangdong, China

Guangzhou No.12 People's Hospital; 🇨🇳 Guangzhou, Guangdong, China