NCT07165158Not yet recruitingPhase 4
The Effect of Semaglutide on Bone Health
The Effect of Semaglutide on Osteoporotic Fractures in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 17 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 1 Sept 2025
- Start date
- 15 Sept 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- The First Affiliated Hospital of Xiamen University
- Diseases
- Type 2 diabetes, Osteoporosis
- NCT number
- NCT07165158
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- From 15 Sept 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received strong anti-osteoporosis medications such as bisphosphonates, denosumab, or teriparatide within the past 2 years,
Other illness
- History of secondary osteoporosis,
- History of malignant tumors,
- Family history of medullary carcinoma.
Lab values
- 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;
Other
- Bone mineral density (lumbar spine, hip, or femoral neck) T-score \< -2.5,
Who the study is looking for
- 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).
Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.