Effect of GLP-1 Receptor Agonists on Trabecular Bone Score

Phase 2

Terminated

• Conditions: Osteoporosis, Postmenopausal; Diabetes Mellitus, Type 2
• Interventions: Drug: GLP-1 receptor agonist

• Registration Number: NCT04964388
• Lead Sponsor: University of Mississippi Medical Center

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.

Study Timeline

• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-16
• Study Start: 2021-11-09
• Primary Completion: 2023-05-01
• Study Completion: 2023-07-01
• Results First Submitted: 2024-05-17
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-26
• Last Update Submitted: 2024-06-26
• Results First Posted: 2024-07-24
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLP-1 cohort	GLP-1 receptor agonist	Participants on GLP-1 receptor agonists

Primary Outcome Measures

Name	Time	Method
Trabecular Bone Score	12 months after index date	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.

Secondary Outcome Measures

Name	Time	Method
Sclerostin and Bone Formation Markers	12 months after index date	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.
Visceral Fat Mass	12 months after index date	The change in visceral fat mass (measured by DXA) at 6 and 1 year after starting GLP-1 receptor agonists as compared to baseline.
Inflammatory Markers and Bone Resorption Markers	12 months after index date	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.

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States