Status:
COMPLETED
Effect of Dexlansoprazole on Bone Homeostasis
Lead Sponsor:
Takeda
Conditions:
Homeostasis
Bone and Bones
Eligibility:
FEMALE
Up to 75 years
Phase:
PHASE1
Brief 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 a...
Eligibility Criteria
Inclusion
- Is postmenopausal female in general good health with a body mass index of ≥18 and ≤30 kg/m2.
- Must have biochemical markers of bone formation, procollagen type 1 N-terminal propeptide and bone-specific alkaline phosphatase, and bone resorption, crosslinked β-C-terminal telopeptide of type 1 collagen and urine N-telopeptide within normal postmenopausal female ranges.
- Has not taken proton pump inhibitor medications within 6 months prior to screening and agrees to refrain from taking them through the last dose of study drug, except study-supplied dexlansoprazole or esomeprazole.
Exclusion
- Has parathyroid hormone or thyroid stimulating hormone levels outside of the reference range at Week -12 and has 25-OH-D level \<32 ng/mL at Week -2.
- Has baseline bone mineral density by dual-energy x-ray absorptiometry defined as a T-score lower than -2.0 at the total hip, spine, or femoral neck based on Caucasian reference values.
- Has a disorder strongly associated with osteoporosis
- Has a history of lumbar laminectomy, vertebroplasty, vertebral deformity or severe lumbar scoliosis that interferes with measurement or performance of the dual x-ray absorptiometry .
- Has a history or clinical manifestations of uncontrolled or significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, or psychiatric disorder as determined by the investigator which may affect the ability of the subject to participate or potentially confound the trial results.
- Has family history of genetic bone disorders.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT01216293
Start Date
November 1 2010
End Date
February 1 2015
Last Update
March 18 2024
Active Locations (12)
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1
San Diego, California, United States
2
Walnut Creek, California, United States
3
Lakewood, Colorado, United States
4
Hialeah, Florida, United States