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NCT Number: NCT07165158

The Effect of Semaglutide on Bone Health

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. lumbar bone mineral density

    Time frame: From enrollment to the end of treatment at 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Xiulin Shi

CONTACT

[email protected]

0592-2139940

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Collaborators

  • Jinzhou Medical University
  • Peking University First Hospital
  • Shanghai 6th People's Hospital
  • Shanghai Punan Hospital of Pudong New District

Registry information

Official study title

The Effect of Semaglutide on Osteoporotic Fractures in Patients With Type 2 Diabetes

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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