The Effect of Semaglutide on Osteoporotic Fractures in Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- lumbar bone mineral density
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes (according to WHO diagnostic criteria),
- •Age range: 50 to ≦75 years,
- •Glycosylated hemoglobin (HbA1c): 6.5 to ≦9.0%,
- •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,
- •No use of antidiabetic medications in 8 weeks prior to enrollment (excluding metformin).
排除标准
- •Bone mineral density (lumbar spine, hip, or femoral neck) T-score < -2.5,
- •History of secondary osteoporosis,
- •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㎡),
- •History of malignant tumors,
- •Received strong anti-osteoporosis medications such as bisphosphonates, denosumab, or teriparatide within the past 2 years,
- •History of pancreatitis or triglyceride levels >5.6 mmol/L;
- •Family history of medullary carcinoma.
研究组 & 干预措施
The intervention group
In the intervention group, the participants will receive semaglutide combined with metformin treatment.
干预措施: semaglutide combined with metformin (Drug)
结局指标
主要结局
lumbar bone mineral density
时间窗: From enrollment to the end of treatment at 12 months
次要结局
未报告次要终点