Effect of GLP-1 Receptor Agonists on Trabecular Bone Score
Primary Purpose
Osteoporosis, Postmenopausal, Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GLP-1 receptor agonist
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis, Postmenopausal
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
Sites / Locations
- University of Mississippi Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
GLP-1 cohort
Non GLP-1 cohort
Arm Description
Participants on GLP-1 receptor agonists
Participants not on GLP-1 receptor agonists
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04964388
First Posted
July 7, 2021
Last Updated
May 8, 2023
Sponsor
University of Mississippi Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04964388
Brief Title
Effect of GLP-1 Receptor Agonists on Trabecular Bone Score
Official Title
Effect of GLP-1 Receptor Agonists on Trabecular Bone Score and Visceral Adiposity in Postmenopausal Women With Type 2 Diabetes Mellitus.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Mississippi Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GLP-1 cohort
Arm Type
Experimental
Arm Description
Participants on GLP-1 receptor agonists
Arm Title
Non GLP-1 cohort
Arm Type
No Intervention
Arm Description
Participants not on GLP-1 receptor agonists
Intervention Type
Drug
Intervention Name(s)
GLP-1 receptor agonist
Intervention Description
Diabetes medication
Primary Outcome Measure Information:
Title
Trabecular bone score
Description
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 Outcome Measure Information:
Title
Inflammatory markers and Bone resorption markers
Description
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
Title
Visceral fat mass
Description
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
Title
Sclerostin and Bone formation markers
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vishnu V Garla
Phone
3049726961
Email
vgarla@umc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vishnu V Garla, MD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vishnu V Garla
Phone
304-972-6961
Email
vgarla@umc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No sharing
Learn more about this trial
Effect of GLP-1 Receptor Agonists on Trabecular Bone Score
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