Effect of Dexlansoprazole on Bone Homeostasis

Summary

The purpose of this study is to evaluate the effect of dexlansoprazole modified release (MR), once daily (QD), on bone homeostasis.

Timeline

Start

2010-11-01

Primary completion

2014-08-01

Completion

2015-02-01

Outcome

Met primary endpoint

paper The esomeprazole and dexlansoprazole groups had significantly increased levels of P1NP (18.2% and 19.2%, respectively) PMID 30445008 ↗

paper and CTX (22.0% and 27.4%, respectively) at week 26 compared with the placebo group PMID 30445008 ↗

Publications

• Hansen KE, Nieves JW, Nudurupati S, Metz DC, Perez MC. Dexlansoprazole and Esomeprazole Do Not Affect Bone Homeostasis in Healthy Postmenopausal Women. Gastroenterology. 2019 Mar;156(4):926-934.e6. doi: 10.1053/j.gastro.2018.11.023. Epub 2018 Nov 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexlansoprazole	Other / unclassified	60 mg	Oral
Comparator	Esomeprazole	Small molecule	40 mg	Oral

Indications