NCT04964388

Effect of GLP-1 Receptor Agonists on Trabecular Bone Score

Effect of GLP-1 Receptor Agonists on Trabecular Bone Score and Visceral Adiposity in Postmenopausal Women With Type 2 Diabetes Mellitus.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Mississippi Medical Center · Academic / Other
• Sex: Female
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This study will help determine the effect of Glucagon Like Peptide-1 (GLP-1)receptor agonists on bone strength in postmenopausal women with type 2 diabetes mellitus (T2DM)

Detailed description

Postmenopausal women with diabetes mellitus have a higher risk of osteoporotic fractures, with significant associated mortality and morbidity. Osteoporosis is underdiagnosed in diabetes, as the bone mineral density (BMD) as currently measured is often normal despite underlying abnormalities. The trabecular bone score (TBS) is a novel modality to assess bone microarchitecture and accurately assess fracture risk in patients with diabetes. Due to increased co-prevalence of osteoporosis and diabetes mellitus, the potential effects of antidiabetic medications on fracture risk assume importance. Based on findings in animal studies, we hypothesize that GLP-1 receptor agonists increase TBS in postmenopausal women with (T2DM). The investigators propose a prospective non-randomized study by enrolling 48 patients (24 in the GLP-1 group and 24 in the non-GLP group). Dual-energy X-ray Absorptiometry (DXA )scans, markers of bone formation, and resorption, and selected inflammatory markers will be assessed at baseline, six months, and one year.

Conditions

• Osteoporosis, Postmenopausal
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	GLP-1 receptor agonist	Diabetes medication

Timeline

• Start date: 2021-11-09
• Primary completion: 2023-05-01
• Completion: 2023-07-01
• First posted: 2021-07-16
• Last updated: 2025-06-13
• Results posted: 2024-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study