Osteoporosis, PostmenopausalPhase 2NCT04964388
Effect of GLP-1 Receptor Agonists on Trabecular Bone Score
A Phase 2 study testing GLP-1 receptor agonist in people with Osteoporosis, Postmenopausal and Diabetes Mellitus, Type 2, run by University of Mississippi Medical Center at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal, Diabetes Mellitus, Type 2
- What is being tested?
- GLP-1 receptor agonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2021to 1 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Type 2 Diabetes Mellitus
- Postmenopausal female
- Age >55 years
- Hemoglobin A1c between 7-10% within 6 months of the first visit.
Who cannot join
- 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
Show all 9Show fewer
- Documented secondary osteoporosis
- Documented presence of prosthesis or devices in the spine
- Unwilling or unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Effect of GLP-1 Receptor Agonists on Trabecular Bone Score and Visceral Adiposity in Postmenopausal Women With Type 2 Diabetes Mellitus.
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)
Read the 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.
- Being tested
- GLP-1 receptor agonist
- Medical subject headings
- Osteoporosis, Postmenopausal, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 receptor agonistDrug
Diabetes medication
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 cohort | Experimental | Participants on GLP-1 receptor agonists Receives: Drug: GLP-1 receptor agonist |
| Non GLP-1 cohort | No intervention | Participants not on GLP-1 receptor agonists |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after index date
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 months after index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start9 Nov 2021
- Primary completion1 May 2023
- Study completion1 Jul 2023
Why it stopped: Not able to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vishnu V Garla, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964388
- Sponsor's protocol ID
- UMississippi
- Status last verified
- May 2025
- First submitted
- 7 Jul 2021
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of GLP-1 Receptor Agonists on Trabecular Bone Score and Visceral Adiposity in Postmenopausal Women With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT04964388
- Acronym / sponsor ID
- UMississippi
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not able to recruit participants
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Posted 24 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 cohort | Experimental | Drug: GLP-1 receptor agonistParticipants on GLP-1 receptor agonists |
| Non GLP-1 cohort | No intervention | –Participants not on GLP-1 receptor agonists |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Type 2 Diabetes Mellitus
- Postmenopausal female
- Age >55 years
- Hemoglobin A1c between 7-10% within 6 months of the first visit.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 receptor agonistDiabetes medication | Drug | GLP-1 cohort |
Primary outcome
Trabecular Bone Score
Time frame: 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.
3 secondary outcomes
Inflammatory Markers and Bone Resorption Markers
Time frame: 12 months after index date
Visceral Fat Mass
Time frame: 12 months after index date
Sclerostin and Bone Formation Markers
Time frame: 12 months after index date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vishnu V Garla, MD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GLP-1 receptor agonist in people with Osteoporosis, Postmenopausal and Diabetes Mellitus, Type 2, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trabecular Bone Score (time frame: 12 months after index date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.