Effect of GLP-1 Receptor Agonists on Trabecular Bone Score

University of Mississippi

Status and phase: Terminated; Phase 2

Conditions: Diabetes Mellitus, Type 2; Osteoporosis, Postmenopausal

Treatments: Drug: GLP-1 receptor agonist

Study type: Interventional

Funder types: Other

Identifiers

NCT04964388

UMississippi

Details and patient eligibility

About

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)

Full 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.

Enrollment: 5 patients

Sex: Female

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

GLP-1 cohort

Experimental group

Description:

Participants on GLP-1 receptor agonists

Treatment:

Drug: GLP-1 receptor agonist

Non GLP-1 cohort

No Intervention group

Description:

Participants not on GLP-1 receptor agonists