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

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide.

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.

It had two arms (groups): Exenatide then Placebo (experimental) and Placebo then Exenatide (active comparator).

The registry classes the interventions as drug.

More on the Plan

Recent studies have indicated that changes in incretin (INtestinal seCRETion of INsulin) hormones in the setting of T2DM may play a role in bone metabolism.

Due to their glucose lowering effects, incretin hormones have been a therapeutic target for the treatment of T2DM through GLP-1 receptor agonists (i.e. exenatide) or inhibition of incretin hormone metabolism via dipeptidyl peptidase 4 (DPP-4)inhibitors.

Who Took Part

The registry lists 14 actual participants took part.

It was open to women only aged from 45 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Postmenopausal women (as defined by age ≥45 years old or amenorrhea for \>2years).

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: history of pancreatitis.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Each person switched between Exenatide and the comparison at some point, usually with a gap in between.

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2011-02 with completion listed for 2015-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 14 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, all human trials.