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Risk factors and prediction model construction of fracture in type 2 diabetes mellitus patients

Risk factors and prediction model construction of fracture in type 2 diabetes mellitus patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800020077
Enrollment
Unknown
Registered
2018-12-13
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus

Interventions

Sponsors

Tongji Hospital, Tongji University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) men or women aged 50-85 (including 50 and 85) at the time of signing the informed consent; (2) patients meets type 2 diabetes criteria issued by WHO (1999) at the time of screening; During the follow-up period, anti-diabetic drugs and life style control were applied to control their blood glucose except for TZDs and insulin; (3) agree to maintain the same diet and exercise habits throughout the study, and follow up in time according to the study requirements; (4) 18.5 kg/m2 < BMI < 35.0 kg/m2; (5) the t-value of DXA bone density is greater than -2.5; (6) sign a written informed consent and abide by the study protocol.

Exclusion criteria

Exclusion criteria: (1) have a history of significant cardiovascular and cerebrovascular diseases, which is defined as: During the first 6 months of screening, subjects had a history of myocardial infarction, coronary angioplasty or bypass, valvular disease or valvular repair, clinically unstable arrhythmia, unstable angina, transient ischemic attack, and cerebrovascular accident; (2) congestive heart failure classified as class III or IV by the New York heart association (NYHA); (3) a history of unstable or rapidly progressive kidney disease; (4) in the active liver disease phase when screening; (5) a clearly diagnosed history of mental illness; (6) have a history of hemoglobinopathy (e.g., sickle cell anemia or thalassemia, iron granulocyte anemia); (7) subjects with low immunity, such as those who have received organ transplantation or have been diagnosed with human immunodeficiency virus infection (such as HIV); (8) any type of malignant tumor (whether cured or not); (9) diseases or drug use that cause secondary osteoporosis; (10) have a history of drug abuse; (11) clinically diagnosed type 1 diabetes, diabetes caused by pancreatic damage or other special types of diabetes; (12) uncontrolled hypertension with antihypertensive drugs (at least 4 weeks) that has been applied at screening (systolic pressure > 160mmHg or diastolic pressure > 100mmHg at screening); (13) patients usually drink 2 units of > every day or 14 units of > every week; One unit of alcohol is equivalent to 150 mL of wine or 350 mL of beer or 100mL of low-alcohol wine (17 degrees or less), 80mL (>17 degrees or 24 degrees or 50 mL of high-alcohol wine (>24 degrees).

Design outcomes

Primary

MeasureTime frame
Fractures at Lumbar, hip and wrist ;

Secondary

MeasureTime frame
all sites fractures;bone mineral density ;

Countries

China

Contacts

Public ContactLige song

Tongji Hospital, Tongji University School of Medicine

6songlige@tongji.edu.cn+86 15001831669

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026