Trial Outcomes & Findings for Effect of GLP-1 Receptor Agonists on Trabecular Bone Score (NCT NCT04964388)

Last Updated: 2025-06-13

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

12 months after index date

Results posted on

2025-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	GLP-1 Cohort Participants on GLP-1 receptor agonists GLP-1 receptor agonist: Diabetes medication	Non GLP-1 Cohort Participants not on GLP-1 receptor agonists
Overall Study STARTED	3	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	GLP-1 Cohort Participants on GLP-1 receptor agonists GLP-1 receptor agonist: Diabetes medication	Non GLP-1 Cohort Participants not on GLP-1 receptor agonists
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

Effect of GLP-1 Receptor Agonists on Trabecular Bone Score

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GLP-1 Cohort n=3 Participants Participants on GLP-1 receptor agonists GLP-1 receptor agonist: Diabetes medication	Non GLP-1 Cohort n=2 Participants Participants not on GLP-1 receptor agonists	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	58 years n=5 Participants	60 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months after index date

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after index date

Population: Despite several attempts to get in touch with participants we could not get in touch with them therefore no data to report.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after index date

Population: Despite several attempts to get in touch with participants we could not get in touch with them therefore no data to report.

The change in visceral fat mass (measured by DXA) at 6 and 1 year after starting GLP-1 receptor agonists as compared to baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after index date

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.

Outcome measures

Outcome data not reported

Adverse Events

GLP-1 Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non GLP-1 Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amy Wigglesworth

UNIVERSITY OF MISSISSIPPI MEDICAL CENTER

Phone: 6018153164

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place