The Effect of Semaglutide on Bone Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: semaglutide combined with metformin.
- Who it may be relevant to
- Registry conditions: Osteoporosis, Osteoporosis Fracture, T2DM. Basic parameters: 50 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Semaglutide on Osteoporotic Fractures in Patients With Type 2 Diabetes
Overview
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
- Drug semaglutide 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.
Primary outcome measures
- lumbar bone mineral density [Time frame: From enrollment to the end of treatment at 12 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Screening
Study locations
China · 1 center
- The First Affiliated Hospital of Xiamen University — Xiamen
Identifiers
NCT: NCT07165158 · KYLLPJ2025-033