Effect of GLP-1 Receptor Agonists on Trabecular Bone Score

Last updated: June 26, 2024
Sponsor: University of Mississippi Medical Center
Overall Status: Terminated

Phase

2

Condition

Diabetes Mellitus, Type 2

Diabetes Prevention

Osteoporosis

Treatment

GLP-1 receptor agonist

Clinical Study ID

NCT04964388
UMississippi
  • Ages > 55
  • Female

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Type 2 Diabetes Mellitus

  • Postmenopausal female

  • Age >55 years

  • Hemoglobin A1c between 7-10% within 6 months of the first visit.

Exclusion

Exclusion Criteria:

  • Patients with type 1 Diabetes mellitus

  • Patients with a history of GLP-1 receptor agonist/DPP4 inhibitor use

  • eGFR <30 ml/min in the last 3 months

  • Patients with a history of pancreatitis

  • Personal or family history of medullary thyroid cancer

  • Patients with a history of treatment with anti-osteoporosis agents

  • Documented secondary osteoporosis

  • Documented presence of prosthesis or devices in the spine

  • Unwilling or unable to consent

Study Design

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: GLP-1 receptor agonist
Phase: 2
Study Start date:
November 09, 2021
Estimated Completion Date:
July 01, 2023

Study 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.

Connect with a study center

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

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