| Trial ID: | L6270 |
| Source ID: | NCT04964388
|
| Associated Drug: |
Glp-1 Receptor Agonist
|
| Title: |
Effect of GLP-1 Receptor Agonists on Trabecular Bone Score
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04964388/results
|
| Conditions: |
Osteoporosis, Postmenopausal|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: GLP-1 receptor agonist
|
| Outcome Measures: |
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., 12 months after index date | 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., 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., 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
|
| Sponsor/Collaborators: |
Sponsor: University of Mississippi Medical Center
|
| Gender: |
FEMALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
5
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-11-09
|
| Completion Date: |
2023-07-01
|
| Results First Posted: |
2024-07-24
|
| Last Update Posted: |
2024-07-24
|
| Locations: |
University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04964388
|
