Type 2 Diabetes Mellitus and Fragility Fractures Clinical Trial
Official title:
A Prospective Cohort Study:Forecast Fracture Risk With a Serum Marker of Type 2 Diabetes in Guangzhou Community
| Verified date | January 2021 |
| Source | Zhujiang Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Terminated |
| Enrollment | 99 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | November 30, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Baiyun Community Taihe Town | Guangzhou | Guangdong |
| China | Guangzhou No.12 People's Hospital | Guangzhou | Guangdong |
| China | Haizhu Changgang Community | Guangzhou | Guangdong |
| China | Tianhe Community | Guangzhou | Guangdong |
| China | Zhujiang Hospital | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Zhujiang Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | fracture | the participants happen to fracture | 3 years |