Effect of Dexlansoprazole 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.

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.