Effect of Dexlansoprazole on Bone Homeostasis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01216293
First received: October 5, 2010
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Homeostasis
Bone and Bones
Drug: Dexlansoprazole
Drug: Esomeprazole
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percent Change from Baseline to Week 26 in Bone Formation Marker Aminoterminal Propeptide of Type 1 Collagen (P1NP). [ Time Frame: Baseline and Week 26. ] [ Designated as safety issue: No ]
    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). [ Time Frame: Baseline and Week 26. ] [ Designated as safety issue: No ]
    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). [ Time Frame: Baseline and Week 26. ] [ Designated as safety issue: No ]
    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). [ Time Frame: Baseline and Week 26. ] [ Designated as safety issue: No ]
    The percent change in bone formation marker BsAP measured at week 26 from BsAP measured at baseline.


Estimated Enrollment: 240
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Nexium
Placebo Comparator: Placebo QD Drug: Placebo
Placebo-matching capsules, orally, once daily for up to 26 weeks.

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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216293

Locations
United States, California
San Diego, California, United States
Walnut Creek, California, United States
United States, Colorado
Lakewood, Colorado, United States
United States, Florida
Hialeah, Florida, United States
Jupiter, Florida, United States
United States, Maryland
Bethesda, Maryland, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, South Carolina
Spartanburg, South Carolina, United States
United States, Texas
Austin, Texas, United States
San Antonio, Texas, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

Additional Information:
No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01216293     History of Changes
Other Study ID Numbers: TAK-390MR_104, U1111-1116-1638
Study First Received: October 5, 2010
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Esomeprazole
Dexlansoprazole
Lansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014