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Semaglutide and Bone Health in Adults With Type 2 Diabetes

Compares semaglutide plus metformin with metformin alone for bone density in type 2 diabetes.

Plain-language title generated from the registry record
Registry title: The Effect of Semaglutide on Bone Health

Key facts

Where
Xiamen, ChinaSee the site
Phase
Phase 4

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 50 and 75 years old?

Source: NCT07165158, who can take part

Where in China

  • The First Affiliated hospital of Xiamen UniversityXiamen, ChinaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
The First Affiliated Hospital of Xiamen University
Trial code
NCT07165158
Record updated
17 September 2025
Original description
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.Read full original descriptionShow less

The Effect of Semaglutide on Osteoporotic Fractures in Patients With Type 2 Diabetes

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.

Inclusion: 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).

Exclusion: Received strong anti-osteoporosis medications such as bisphosphonates, denosumab, or teriparatide within the past 2 years,; History of secondary osteoporosis,; History of malignant tumors,; Family history of medullary carcinoma; 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 pancreatitis or triglyceride levels >5.6 mmol/L; Bone mineral density (lumbar spine, hip, or femoral neck) T-score < -2.5,.

ClinicalTrials.gov NCT07165158