Effect of Dexlansoprazole on Bone Homeostasis

Sponsor

Takeda (Industry)

Overall Status

Completed

CT.gov ID

NCT01216293

Collaborator

(none)

247

Enrollment

Locations

Arms

Duration (Months)

20.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Homeostasis Bone and Bones	Drug: Dexlansoprazole Drug: Esomeprazole Drug: Placebo	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

247 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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 Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexlansoprazole 60 mg QD	Drug: Dexlansoprazole Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Other Names: Dexilant Kapidex
Active Comparator: Esomeprazole 40mg QD	Drug: Esomeprazole Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Other Names: Nexium
Placebo Comparator: Placebo QD	Drug: Placebo Placebo-matching capsules, orally, once daily for up to 26 weeks.

Arm

Intervention/Treatment

Experimental: Dexlansoprazole 60 mg QD

Drug: Dexlansoprazole

Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks.

Other Names:

Dexilant

Kapidex

Active Comparator: Esomeprazole 40mg QD

Drug: Esomeprazole

Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks.

Other Names:

Nexium

Placebo Comparator: Placebo QD

Drug: Placebo

Placebo-matching capsules, orally, once daily for up to 26 weeks.

Outcome Measures

Primary Outcome Measures

Percent Change from Baseline to Week 26 in Bone Formation Marker Aminoterminal Propeptide of Type 1 Collagen (P1NP). [Baseline and Week 26.]
The percent change in bone formation marker P1NP measured at week 26 from P1NP measured at baseline.
Percent Change from Baseline to Week 26 in Bone Resorption Marker C-telopeptide of Collagen Cross-links (CTX). [Baseline and Week 26.]
The percent change in bone resorption marker CTX measured at week 26 from CTX measured at baseline.

Secondary Outcome Measures

Percent Change from Baseline to Week 26 in Urine N-telopeptide of Collagen Cross-links (NTx). [Baseline and Week 26.]
The percent change in bone resorption marker NTx measured at week 26 from NTx measured at baseline.
Percent Change from Baseline to Week 26 in Bone-specific Alkaline Phosphatase (BsAP). [Baseline and Week 26.]
The percent change in bone formation marker BsAP measured at week 26 from BsAP measured at baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	City	State	Country
1	San Diego	California	United States
2	Walnut Creek	California	United States
3	Lakewood	Colorado	United States
4	Hialeah	Florida	United States
5	Jupiter	Florida	United States
6	Bethesda	Maryland	United States
7	Albuquerque	New Mexico	United States
8	Spartanburg	South Carolina	United States
9	Austin	Texas	United States
10	San Antonio	Texas	United States
11	Seattle	Washington	United States
12	Madison	Wisconsin	United States