Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
115 participants
INTERVENTIONAL
2010-11-01
2015-02-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Placebo
Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.
Placebo
Placebo-matching capsules
Dexlansoprazole 60 mg
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
Dexlansoprazole
Dexlansoprazole 60 mg capsules
Esomeprazole 40mg
Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
Esomeprazole
Esomeprazole 40 mg capsules
Interventions
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Dexlansoprazole
Dexlansoprazole 60 mg capsules
Esomeprazole
Esomeprazole 40 mg capsules
Placebo
Placebo-matching capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
75 Years
FEMALE
Yes
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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San Diego, California, United States
Walnut Creek, California, United States
Lakewood, Colorado, United States
Hialeah, Florida, United States
Jupiter, Florida, United States
Bethesda, Maryland, United States
Albuquerque, New Mexico, United States
Spartanburg, South Carolina, United States
Austin, Texas, United States
San Antonio, Texas, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Countries
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References
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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.
Related Links
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Other Identifiers
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U1111-1116-1638
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-390MR_104
Identifier Type: -
Identifier Source: org_study_id
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