The Effect of Semaglutide on Bone Health
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50-75
SponsorThe First Affiliated Hospital of Xiamen University
About this trial
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.
Eligibility criteria
Qualifiers
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,
Disqualifiers
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,
Trial design
Treatments tested in this trial
- semaglutide combined with metformin
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
The First Affiliated Hospital of Xiamen University
Lead sponsor
Peking University First Hospital
Collaborator
Shanghai Punan Hospital of Pudong New District
Collaborator
Shanghai 6th People's Hospital
Collaborator
Jinzhou Medical University
Collaborator
Source ClinicalTrials.gov