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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLP-1 cohort | Experimental | Participants on GLP-1 receptor agonists |
|
| Non GLP-1 cohort | No Intervention | Participants not on GLP-1 receptor agonists |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLP-1 receptor agonist | Drug | Diabetes medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after index date |
| Visceral Fat Mass |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vishnu V Garla, MD | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | GLP-1 Cohort | Participants on GLP-1 receptor agonists GLP-1 receptor agonist: Diabetes medication |
| FG001 | Non GLP-1 Cohort | Participants not on GLP-1 receptor agonists |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GLP-1 Cohort | Participants on GLP-1 receptor agonists GLP-1 receptor agonist: Diabetes medication |
| BG001 | Non GLP-1 Cohort | Participants not on GLP-1 receptor agonists |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Unfortunately at the time of enrollment the dexa scan was not functioning, after the machine was fixed we tried several times to contact the participants but could not get in touch with them. Therefore no dexa scans were done on the participants so no data was captured. | Posted | 12 months after index date |
|
The specific period of time over which each participant was assessed would have been one year However, none of the participants were lost to follow-up, so adverse events could not be assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GLP-1 Cohort | Participants on GLP-1 receptor agonists GLP-1 receptor agonist: Diabetes medication |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Wigglesworth | UNIVERSITY OF MISSISSIPPI MEDICAL CENTER | 6018153164 | ajwigglesworth@umc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2021 | May 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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The change in visceral fat mass (measured by DXA) at 6 and 1 year after starting GLP-1 receptor agonists as compared to baseline. |
| 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. | 12 months after index date |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants not on GLP-1 receptor agonists
|
| Secondary | 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. | Despite several attempts to get in touch with participants we could not get in touch with them therefore no data to report. | Posted | 12 months after index date |
|
|
| Secondary | 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. | Despite several attempts to get in touch with participants we could not get in touch with them therefore no data to report. | Posted | 12 months after index date |
|
|
| Secondary | 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. | Not Posted | 12 months after index date | Participants |
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Non GLP-1 Cohort | Participants not on GLP-1 receptor agonists | 0 | 2 | 0 | 2 | 0 | 2 |
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |