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CMBD

TerminatedPhase 4Results posted

Changes in Bone Turnover With Exposure to a GLP-1 Receptor Agonist

Changes in Bone Turnover With Exposure to a GLP-1 Receptor Agonist (UAB Core Center for Basic Skeletal Research)

Lead sponsor

University of Alabama at Birmingham

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criteria

•HbA1c 6.5-9%•Female

Primary endpoints

•Determine Changes in Bone Resorption Markers During the Treatment With a GLP-1•Determine Changes in Bone Turnover Markers by Serum N-Telo Peptide During•TRACP5b

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01381926

Org study IDF100929001

Timeline

Milestones

Study first posted2011-06-27estimated

Last update posted2017-06-14actual

Results first posted2017-06-14actual

Study start2011-02 (month precision)

Primary completion2015-08actual (month precision)

Study completion2015-08actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age45 Years

SexFemale

Healthy volunteersAccepted

Inclusion criteria

•Postmenopausal women (as defined by age ≥45 years old or amenorrhea for >2years)

•Type 2 DM currently not on diabetes-specific medication(s) or treated with monotherapy of metformin or a sulfonylurea. Patients treated with insulin monotherapy will also be eligible if the total daily dose of insulin is ≤10units. If on a medication for diabetes prior to study entry, the medication can be discontinued for 2 weeks prior to study initiation.

•Hemoglobin A1c (HbA1c) of 6.5-9.0%

Exclusion criteria

•Use of an incretin mimetic (i.e. exenatide, liraglutide), a DPP-4 inhibitor (i.e. sitagliptin, saxagliptin), a thiazolidinedione, or oral glucocorticoids in the 6 months prior to the study will not be eligible

•Known osteoporosis or patients treated with an osteoporosis-specific medication (bisphosphonate, teriparatide) or estrogen (including Selective Estrogen Receptor Modulators (SERMs)) or those who anticipate imminent treatment with one of these medications will be excluded from the study

•Chronic kidney disease (calculated GFR <30 ml/min) or a disease known to affect bone turnover (i.e. Paget Disease, Osteogenesis Imperfecta, HIV) will be excluded from the study.

•History of pancreatitis

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other clinical outcomes

3 endpoints

Primary/protocol endpoint

Determine Changes in Bone Resorption Markers During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.

Time frame:Baseline to 20 weeks

change from baseline, improvement

Posted result

Group	Value (mean), mg/L	95% CI
Exenatide 1st Then Placebo	1.925	—
Placebo 1st Then Exenatide	-0.20	—

Primary/protocol endpoint

Determine Changes in Bone Turnover Markers by Serum N-Telo Peptide During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.

Time frame:Baseline to 20 weeks

change from baseline, improvement

Posted result

Group	Value (mean), nMBCE/L	95% CI
Exenatide Then Placebo	-0.8	—
Placebo Then Exenatide	1.725	—

Primary/protocol endpoint

Determine Changes in Bone Turnover Markers by Tartrate-Resistant Acid Phosphatase 5b (TRACP5b) During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.

Time frame:Baseline to 20 weeks

TRACP5b

change from baseline, descriptive

Posted result

Group	Value (mean), U/L	95% CI
Exenatide 1st Then Placebo	0.05	—
Placebo 1st Then Exenatide	0.325	—

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.