Clinical trial NCT04964388: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoporosis, Postmenopausal
Diabetes Mellitus, Type 2
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 5
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Trabecular Bone Score
timeFrame: 12 months after index date
Secondary outcomes:
measure: Inflammatory Markers and Bone Resorption Markers
timeFrame: 12 months after index date
measure: Visceral Fat Mass
timeFrame: 12 months after index date
measure: Sclerostin and Bone Formation Markers
timeFrame: 12 months after index date
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Vishnu V Garla, MD
role: PRINCIPAL_INVESTIGATOR
References: