NCT01216293

Effect of Dexlansoprazole on Bone Homeostasis

Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Dexlansoprazole 60 mg Delayed Release Capsules and Esomeprazole 40 mg Delayed Release Capsules on Bone Homeostasis in Healthy Postmenopausal Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Takeda · Industry
• Sex: Female
• Age: 75 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Research on drugs that affect bone homeostasis have shown changes in levels of bone formation and resorption biomarkers. This study will evaluate the effect of dexlansoprazole on bone homeostasis by assessing changes in biochemical markers of bone formation and bone resorption. This study will also assess changes in bone mineral density by dual-energy x-ray absorptiometry scan and other markers of bone homeostasis. The study will consist of a 12-week screening period, a 26-week treatment period with a total of 5 visits during the treatment period and a follow-up visit at Week 52 for bone mineral density assessment.

Conditions

• Homeostasis
• Bone and Bones

Interventions

Type	Name	Description
DRUG	Dexlansoprazole	Dexlansoprazole 60 mg capsules
DRUG	Esomeprazole	Esomeprazole 40 mg capsules
DRUG	Placebo	Placebo-matching capsules

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-08-01
• Completion: 2015-02-01
• First posted: 2010-10-07
• Last updated: 2024-03-18
• Results posted: 2024-03-18

Locations

12 sites across 1 country: United States