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

NCT01381926 · Terminated

Last updated 2026-05-28

This clinical trial tested how a medication called exenatide, used to treat type 2 diabetes, affects bone health in adults with type 2 diabetes by measuring changes in bone breakdown markers compared to a placebo.

Status Terminated Stopped early and will not restart.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 14 people

Who can join Ages 45+ · female only Healthy volunteers accepted.

Timeline Started 2011-02 · est. completion 2015-08

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT01381926 ↗

Description as written by the study sponsor.

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.

Treatments tested

exenatide also known as Byetta Drug

exenatide 5mcg sq twice daily for one month and exenatide 10mcg twice daily for month 2. The 3rd month is a washout period. Month 4 and 5 saline placebo is given as 5mcg and 10mcg respectively.
Saline also known as Normal Saline Drug

Month 1 and 2 saline placebo is given as a low and high dose respectively. The 3rd month is a washout period. Month 4 exenatide 5mcg sq twice daily and for month 5 exenatide 10mcg twice daily is administered.

Main thing measured	Determine Changes in Bone Resorption Markers During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.
Sponsor	University of Alabama at Birmingham
Conditions studied	Type 2 Diabetes Mellitus, Bone Remodeling
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01381926 ↗