The Effect of Semaglutide on Bone Health

NCT07165158 | Not Yet Recruiting Phase 4

• 1 other identifier: KYLLPJ2025-033
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Osteoporosis; Osteoporosis Fracture; T2DM

Keywords

antidiabetic drug; osteoporosis fracture; T2DM

Outcome Measures

Primary Outcomes (1)

• lumbar bone mineral density

  From enrollment to the end of treatment at 12 months

Study Arms (2)

The intervention group

EXPERIMENTAL

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

Drug: semaglutide combined with metformin

The control group

NO INTERVENTION

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

Interventions

semaglutide combined with metformin DRUG

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.

The intervention group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead
• Peking University First Hospital: collaborator
• Shanghai Punan Hospital of Pudong New District: collaborator
• Shanghai 6th People's Hospital: collaborator
• Jinzhou Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Location

MeSH Terms

Conditions

Osteoporosis; Osteoporotic Fractures

Interventions

Metformin

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Xiulin Shi

CONTACT

0592-2139940; shixiulin2022@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 10, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-08

Locations

CN (1)