A Phase 4 interventional study of semaglutide combined with metformin in Osteoporosis, Osteoporosis Fracture and T2DM, sponsored by The First Affiliated Hospital of Xiamen University. Not yet recruiting at 1 site in China. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by The First Affiliated Hospital of Xiamen University · Phase 4, Interventional, and Screening
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's planned enrollment of 150 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →The First Affiliated Hospital of Xiamen University is the lead sponsor of 115 studies on the registry; 76 are open to participants now.
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In the intervention group, the participants will receive semaglutide combined with metformin treatment.
Drug: semaglutide combined with metformin
In the control group, the participants will be treated with metformin alone (500mg each time, three times a day).
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.
lumbar bone mineral density
Time frame: From enrollment to the end of treatment at 12 months
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Xiamen University