Effect of GLP-1 Receptor Agonists on Trabecular Bone Score

Phase 2TerminatedNCT04964388

University of Mississippi Medical Center5 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoporosis, Postmenopausal Diabetes Mellitus, Type 2

Interventions

GLP-1 receptor agonistDRUG

Diabetes medication

Eligibility

Sex: FEMALEMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Mississippi Medical Center

Jackson, Mississippi, United States

Outcomes

Primary Outcomes

Trabecular Bone Score

The change in TBS from baseline to six months and one year after the initiation of a GLP-1 receptor agonist. TBS will be assessed by DXA scans done at baseline, six months and one year.

Time frame: 12 months after index date

Secondary Outcomes

Inflammatory Markers and Bone Resorption Markers

The change in inflammatory markers (IL-1, IL-6 and TNF-alpha) and bone resorption markers (C-telopeptide) at 6 and 12 months after starting GLP-1 receptor agonists as compared to baseline.

Time frame: 12 months after index date

Visceral Fat Mass

The change in visceral fat mass (measured by DXA) at 6 and 1 year after starting GLP-1 receptor agonists as compared to baseline.

Time frame: 12 months after index date

Sclerostin and Bone Formation Markers

The change in levels of sclerostin, osteocalcin, and P1NP (as measured by commercial assays) from baseline to six months and one year after starting GLP-1 receptor agonist.

Time frame: 12 months after index date

Data from ClinicalTrials.gov

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