The Effect of Semaglutide on Bone Health

Xiamen University

Status and phase: Not yet enrolling; Phase 4

Conditions: Osteoporosis; Osteoporosis Fracture; T2DM

Treatments: Drug: semaglutide combined with metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT07165158

KYLLPJ2025-033

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

The intervention group

Experimental group

Description:

In the intervention group, the participants will receive semaglutide combined with metformin treatment.

Treatment:

Drug: semaglutide combined with metformin

The control group

No Intervention group

Description:

In the control group, the participants will be treated with metformin alone (500mg each time, three times a day).