Status:
NOT_YET_RECRUITING
The Effect of Semaglutide on Bone Health
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Collaborating Sponsors:
Peking University First Hospital
Shanghai Punan Hospital of Pudong New District
Conditions:
Osteoporosis
Osteoporosis Fracture
Eligibility:
All Genders
50-75 years
Phase:
PHASE4
Brief Summary
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 a...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07165158
Start Date
September 15 2025
End Date
December 31 2026
Last Update
September 17 2025
Active Locations (1)
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1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China