The purpose of this study is to evaluate the effect of dexlansoprazole modified release (MR), once daily (QD), on bone homeostasis.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
115
Dexlansoprazole 60 mg capsules
Esomeprazole 40 mg capsules
Placebo-matching capsules
Unnamed facility
San Diego, California, United States
Unnamed facility
Walnut Creek, California, United States
Unnamed facility
Lakewood, Colorado, United States
Unnamed facility
Hialeah, Florida, United States
Percent Change From Baseline to Week 26 in Bone Formation Marker Aminoterminal Propeptide of Type 1 Collagen (P1NP)
The percent change in bone formation marker P1NP measured at week 26 from P1NP measured at baseline. Serum samples for P1NP were analyzed at a central laboratory for bone biomarker P1NP using an electrochemiluminescence immunoassay measured in nanograms per milliliter (ng/mL).
Time frame: Baseline and Week 26
Percent Change From Baseline to Week 26 in Bone Resorption Marker C-telopeptide of Collagen Cross-links (CTX)
The percent change in bone resorption marker CTX measured at week 26 from CTX measured at baseline. Plasma samples were analyzed at a central laboratory for bone biomarker CTX using an electrochemiluminescence immunoassay measured in ng/mL.
Time frame: Baseline and Week 26
Percent Change From Baseline to Week 26 in Urine N-telopeptide of Collagen Cross-links (NTx) Calculated
The percent change in bone resorption marker NTx measured at week 26 from NTx measured at baseline. Urine samples were analyzed at a central laboratory for NTx using an enzyme-linked immunosorbent assay calculated as (nmol BCE/mmol creatinine). BCE=bone collagen equivalent
Time frame: Baseline and Week 26
Percent Change From Baseline to Week 26 in Bone-specific Alkaline Phosphatase (BsAP)
The percent change in bone formation marker BsAP measured at week 26 from BsAP measured at baseline. Serum samples were analyzed at a central laboratory for bone biomarker BsAP using an enzyme immunoassay measured in units per liter (U/L).
Time frame: Baseline and Week 26
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Unnamed facility
Jupiter, Florida, United States
Unnamed facility
Bethesda, Maryland, United States
Unnamed facility
Albuquerque, New Mexico, United States
Unnamed facility
Spartanburg, South Carolina, United States
Unnamed facility
Austin, Texas, United States
Unnamed facility
San Antonio, Texas, United States
...and 2 more locations