Effect of Dexlansoprazole on Bone Homeostasis

Condition(s) targeted: Homeostasis; Bone and Bones

Intervention: Dexlansoprazole (Drug); Esomeprazole (Drug); Placebo (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Takeda Global Research & Development Center, Inc.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Takeda Global Research & Development Center, Inc.

Overall contact:
Takeda Study Registration Call Center, Phone: 800-778-2860, Email: medicalinformation@tpna.com

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

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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary outcome:

Percent Change from Baseline to Week 26 in Bone Formation Marker Aminoterminal Propeptide of Type 1 Collagen (P1NP).

Percent Change from Baseline to Week 26 in Bone Resorption Marker C-telopeptide of Collagen Cross-links (CTX).

Secondary outcome:

Percent Change from Baseline to Week 26 in Urine N-telopeptide of Collagen Cross-links (NTx).

Percent Change from Baseline to Week 26 in Bone-specific Alkaline Phosphatase (BsAP).

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.

Minimum age: N/A. Maximum age: 75 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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.

Takeda Study Registration Call Center, Phone: 800-778-2860, Email: medicalinformation@tpna.com

San Diego, California, United States; Completed

Walnut Creek, California, United States; Recruiting

Lakewood, Colorado, United States; Recruiting

Jupiter, Florida, United States; Recruiting

Miami, Florida, United States; Recruiting

Bethesda, Maryland, United States; Recruiting

Albuquerque, New Mexico, United States; Recruiting

Spartanburg, South Carolina, United States; Recruiting

Austin, Texas, United States; Recruiting

San Antonio, Texas, United States; Recruiting

Seattle, Washington, United States; Recruiting

Madison, Wisconsin, United States; Recruiting

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Starting date: January 2011
Last updated: November 15, 2011