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Completed

NCT Number: NCT01216293

Effect of Dexlansoprazole on Bone Homeostasis

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

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Key information

Conditions

Homeostasis Bone And Bones

Age range

Up to 75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dexlansoprazole

Drug

Dexlansoprazole 60 mg capsules

Other names: Dexilant, Kapidex

Esomeprazole

Drug

Esomeprazole 40 mg capsules

Other names: Nexium

Placebo

Drug

Placebo-matching capsules

Primary outcomes

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

    Time frame: Baseline and Week 26

    The percent change in bone formation marker P1NP measured at week 26 from P1NP measured at baseline. Serum samples for P1NP were analyzed at a central laboratory for bone biomarker P1NP using an electrochemiluminescence immunoassay measured in nanograms per milliliter (ng/mL).

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

    Time frame: Baseline and Week 26

    The percent change in bone resorption marker CTX measured at week 26 from CTX measured at baseline. Plasma samples were analyzed at a central laboratory for bone biomarker CTX using an electrochemiluminescence immunoassay measured in ng/mL.

Secondary outcomes

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

    Time frame: Baseline and Week 26

    The percent change in bone resorption marker NTx measured at week 26 from NTx measured at baseline. Urine samples were analyzed at a central laboratory for NTx using an enzyme-linked immunosorbent assay calculated as (nmol BCE/mmol creatinine). BCE=bone collagen equivalent

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

    Time frame: Baseline and Week 26

    The percent change in bone formation marker BsAP measured at week 26 from BsAP measured at baseline. Serum samples were analyzed at a central laboratory for bone biomarker BsAP using an enzyme immunoassay measured in units per liter (U/L).

Other outcomes

  1. Percent Change From Baseline in P1NP at Week 13

    Time frame: Baseline and Week 13

    Serum samples for P1NP were analyzed using an electrochemiluminescence immunoassay measured in ng/mL.

  2. Percent Change From Baseline in CTX at Week 13

    Time frame: Baseline and Week 13

    Plasma samples were analyzed for bone biomarker CTX using an electrochemiluminescence immunoassay measured in ng/mL.

  3. Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 26

    Time frame: Baseline and Week 26

    DXA is a means of measuring BMD through x-ray.

  4. Percent Change From Baseline in Total Hip BMD Measured by DXA at Week 26

    Time frame: Baseline and Week 26

    DXA is a means of measuring BMD through x-ray.

  5. Percent Change From Baseline in Lumbar Spine BMD Measured by DXA at Week 26

    Time frame: Baseline and Week 26

    DXA is a means of measuring BMD through x-ray.

  6. Percent Change From Week 26 in Femoral Neck BMD Measured by DXA at Week 52

    Time frame: Week 26 and Week 52

    DXA is a means of measuring BMD through x-ray.

  7. Percent Change From Weeks 26 in Total Hip BMD Measured by DXA at Week 52

    Time frame: Week 26 and Week 52

    DXA is a means of measuring BMD through x-ray.

  8. Percent Change From Weeks 26 in Lumbar Spine BMD Measured by DXA at Week 52

    Time frame: Week 26 and Week 52

  9. Number of Participants With Fracture Including Vertebral Fracture During Study Treatment

    Time frame: Baseline up to Week 26

  10. Change From Baseline in 24-hour Urinary Calcium Excretion at Week 26

    Time frame: Baseline and Week 26

  11. Change From Baseline in Parathyroid Hormone (PTH) at Week 26

    Time frame: Baseline and Week 26

  12. Change From Baseline in Serum Calcium at Week 26

    Time frame: Baseline and Week 26

  13. Change From Baseline in Serum Phosphorus at Week 26

    Time frame: Baseline and Week 26

  14. Change From Baseline in Serum Magnesium at Week 26

    Time frame: Baseline and Week 26

  15. Change From Baseline in Urine Magnesium at Week 26

    Time frame: Baseline and Week 26

  16. Change From Baseline to Week 26 in Vitamin D3 (25-OH-D) Level

    Time frame: Baseline and Week 26

  17. Change From Baseline in Intestinal Calcium Absorption by True Fractional Calcium Absorption (TFCA) in a Subset of Participants at Week 26

    Time frame: Baseline and Week 26

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Oct 7, 2010
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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