Effect of GLP-1 Receptor Agonists on Trabecular Bone Score

NCT04964388 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: UMississippi
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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)

Conditions

Osteoporosis, Postmenopausal; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after index date

Secondary Outcomes (3)

• Inflammatory Markers and Bone Resorption Markers

  12 months after index date

• Visceral Fat Mass

  12 months after index date

• Sclerostin and Bone Formation Markers

  12 months after index date

Study Arms (2)

GLP-1 cohort

EXPERIMENTAL

Participants on GLP-1 receptor agonists

Drug: GLP-1 receptor agonist

Non GLP-1 cohort

NO INTERVENTION

Participants not on GLP-1 receptor agonists

Interventions

GLP-1 receptor agonist DRUG

Diabetes medication

GLP-1 cohort

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Type 2 Diabetes Mellitus
• Postmenopausal female
• Age \>55 years
• Hemoglobin A1c between 7-10% within 6 months of the first visit.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Amy Wigglesworth
• Organization: UNIVERSITY OF MISSISSIPPI MEDICAL CENTER

ajwigglesworth@umc.edu

6018153164

Study Officials

• Vishnu V Garla, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: November 9, 2021
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: June 13, 2025
• Results First Posted: July 24, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)