Effect of Dexlansoprazole on Bone Homeostasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01216293|
Recruitment Status : Completed
First Posted : October 7, 2010
Last Update Posted : March 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Homeostasis Bone and Bones||Drug: Dexlansoprazole Drug: Esomeprazole Drug: Placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||247 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||February 2015|
|Experimental: Dexlansoprazole 60 mg QD||
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks.
|Active Comparator: Esomeprazole 40mg QD||
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks.
Other Name: Nexium
|Placebo Comparator: Placebo QD||
Placebo-matching capsules, orally, once daily for up to 26 weeks.
- Percent Change from Baseline to Week 26 in Bone Formation Marker Aminoterminal Propeptide of Type 1 Collagen (P1NP). [ Time Frame: Baseline and Week 26. ]The percent change in bone formation marker P1NP measured at week 26 from P1NP measured at baseline.
- Percent Change from Baseline to Week 26 in Bone Resorption Marker C-telopeptide of Collagen Cross-links (CTX). [ Time Frame: Baseline and Week 26. ]The percent change in bone resorption marker CTX measured at week 26 from CTX measured at baseline.
- Percent Change from Baseline to Week 26 in Urine N-telopeptide of Collagen Cross-links (NTx). [ Time Frame: Baseline and Week 26. ]The percent change in bone resorption marker NTx measured at week 26 from NTx measured at baseline.
- Percent Change from Baseline to Week 26 in Bone-specific Alkaline Phosphatase (BsAP). [ Time Frame: Baseline and Week 26. ]The percent change in bone formation marker BsAP measured at week 26 from BsAP measured at baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216293
|United States, California|
|San Diego, California, United States|
|Walnut Creek, California, United States|
|United States, Colorado|
|Lakewood, Colorado, United States|
|United States, Florida|
|Hialeah, Florida, United States|
|Jupiter, Florida, United States|
|United States, Maryland|
|Bethesda, Maryland, United States|
|United States, New Mexico|
|Albuquerque, New Mexico, United States|
|United States, South Carolina|
|Spartanburg, South Carolina, United States|
|United States, Texas|
|Austin, Texas, United States|
|San Antonio, Texas, United States|
|United States, Washington|
|Seattle, Washington, United States|
|United States, Wisconsin|
|Madison, Wisconsin, United States|
|Study Director:||Medical Director||Takeda|