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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus, Bone Remodeling

In brief

The purpose of this study is to determine changes in bone turnover markers and calcitonin following the initiation of exenatide compared to placebo in postmenopausal women wtih type 2 diabetes. Hypothesis 1a: Bone resorption (measured by osteocalcin and bone-specific alkaline phosphatase) will be lower and bone formation (measured by type I collagen crosslinked aminoterminal peptide in urine (Urine NTX)) will be higher when subjects are treated with exenatide compared to when subjects are treated with placebo. Hypothesis 1b: Calcitonin levels will not vary significantly between periods of treatment with exenatide vs. placebo.

Key facts

Study ID

NCT01381926

Run by

University of Alabama at Birmingham

People needed

14

Starts

2011-02-01

Expected to finish

2015-08-01

Last updated by the study team

2017-06-14

Who can join

Age: 45 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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