Effect of GLP-1 Receptor Agonists on Trabecular Bone Score

NCT ID: NCT04964388

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-09
• Study Completion Date: 2023-07-01

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GLP-1 cohort

Participants on GLP-1 receptor agonists

Group Type: EXPERIMENTAL

GLP-1 receptor agonist

Intervention Type: DRUG

Diabetes medication

Non GLP-1 cohort

Participants not on GLP-1 receptor agonists

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

GLP-1 receptor agonist

Diabetes medication

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vishnu V Garla, MD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

University of Mississippi Medical Center

Jackson, Mississippi, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UMississippi

Identifier Type: -

Identifier Source: org_study_id