Osteoporosis, Osteoporosis Fracture, T2DM
Conditions
Keywords
antidiabetic drug, osteoporosis fracture, T2DM
Brief summary
Semaglutide has effects that include lowering blood sugar, reducing weight, and improving cardiovascular and renal outcomes, and it is now widely used in clinical practice. Given that weight loss is associated with bone loss, its effect on bone health has recently raised concerns. Therefore, the goal of this clinical trial is to learn the effect of semaglutide on bone mineral density and fractures in patients with type 2 diabetes. The investigators will compare semaglutide combined with metformin to metformin alone to see if semaglutide treatment has effects on bone mineral density and bone turnover markers in patients with type 2 diabetes after 12 months. The intervention group will receive semaglutide combined with metformin for 12 months, while the control group will receive metformin alone for the same duration. After 12 months of treatment, the investigators will compare the bone mineral density, fracture incidence, and levels of bone turnover markers between the two groups.
Interventions
DRUGsemaglutide combined with metformin
The initial dose of semaglutide is 0.25 mg once weekly. After 4 weeks, the dose is adjusted to 0.5 mg once weekly. After another 4 weeks, the dose is adjusted to 1 mg once weekly. During the same period, they will take metformin (500mg each time, three times a day) for treatment. The treatment course is 12 months.
Sponsors
Peking University First Hospital
Shanghai Punan Hospital of Pudong New District
Shanghai 6th People's Hospital
Jinzhou Medical University
The First Affiliated Hospital of Xiamen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes (according to WHO diagnostic criteria), 2. Age range: 50 to ≦75 years, 3. Glycosylated hemoglobin (HbA1c): 6.5 to ≦9.0%, 4. Bone mineral density (lumbar spine, hip, or femoral neck) T-score \< -1, or history of fragility fractures (hip, vertebral, distal forearm, or proximal humerus fractures) within three years before screening, 5. No use of antidiabetic medications in 8 weeks prior to enrollment (excluding metformin).
Exclusion criteria
1. Bone mineral density (lumbar spine, hip, or femoral neck) T-score \< -2.5, 2. History of secondary osteoporosis, 3. Serious liver dysfunction or chronic kidney disease (aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 2.5 times the upper limit of the normal reference, or estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73㎡), 4. History of malignant tumors, 5. Received strong anti-osteoporosis medications such as bisphosphonates, denosumab, or teriparatide within the past 2 years, 6. History of pancreatitis or triglyceride levels \>5.6 mmol/L; 7. Family history of medullary carcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| lumbar bone mineral density | From enrollment to the end of treatment at 12 months |
Countries
China
Contacts
Primary ContactXiulin Shi
Outcome results
None listed