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GLP-1 Receptor Agonist
GLP-1 Agonists for Osteoporosis
Phase 2
Recruiting
Led By Vishnu V Garla, MD
Research Sponsored by University of Mississippi Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after index date
Awards & highlights
Study Summary
This trial will help show if GLP-1 receptor agonists help improve bone strength in postmenopausal women with T2DM.
Eligible Conditions
- Osteoporosis
- Type 2 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months after index date
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after index date
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Trabecular bone score
Secondary outcome measures
Inflammatory markers and Bone resorption markers
Sclerostin and Bone formation markers
Visceral fat mass
Side effects data
From 2021 Phase 4 trial • 70 Patients • NCT031510053%
Aminopherase elevation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Metformin-Oral Contraceptive(OC)
Metformin-GLP-1 Receptor Agonist
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GLP-1 cohortExperimental Treatment1 Intervention
Participants on GLP-1 receptor agonists
Group II: Non GLP-1 cohortActive Control1 Intervention
Participants not on GLP-1 receptor agonists
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GLP-1 receptor agonist
2020
Completed Phase 3
~11540
Find a Location
Who is running the clinical trial?
University of Mississippi Medical CenterLead Sponsor
176 Previous Clinical Trials
195,461 Total Patients Enrolled
1 Trials studying Osteoporosis
197 Patients Enrolled for Osteoporosis
Vishnu V Garla, MDPrincipal InvestigatorUniversity of Mississippi Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used GLP-1 receptor agonists or DPP4 inhibitors in the past.You have type 1 diabetes.Your kidney function has been very low in the past 3 months.You have been diagnosed with secondary osteoporosis.You have had pancreatitis in the past.You have been treated with medications for osteoporosis in the past.You have a medical device in your spine.You have been diagnosed with type 2 diabetes.A woman who has gone through menopause.You are older than 55 years old.Your average blood sugar level (Hemoglobin A1c) is between 7% and 10% in the past 6 months.You or someone in your family has had medullary thyroid cancer.
Research Study Groups:
This trial has the following groups:- Group 1: GLP-1 cohort
- Group 2: Non GLP-1 cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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