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CompletedNCT01216293Updated Mar 18, 2024Results posted

Effect of Dexlansoprazole on Bone Homeostasis

A Phase 1 interventional study of Dexlansoprazole and Esomeprazole in Homeostasis and Bone and Bones, sponsored by Takeda. Completed at 12 sites in United States. Open to female participants aged Up to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.

Sponsored by Takeda · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
115
Allocation
Randomized
Ages
Up to 75 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Homeostasis
  • Bone and Bones

Keywords

  • Drug Therapy
03

In context

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 75 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
115 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26.

    Drug: Placebo

  • Experimental
    Dexlansoprazole 60 mg

    Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.

    Drug: Dexlansoprazole

  • Active comparator
    Esomeprazole 40mg

    Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.

    Drug: Esomeprazole

Interventions

  • DrugDexlansoprazole

    Dexlansoprazole 60 mg capsules

    Also known as: Dexilant, Kapidex

  • DrugEsomeprazole

    Esomeprazole 40 mg capsules

    Also known as: Nexium

  • DrugPlacebo

    Placebo-matching capsules

06

What researchers measure

Primary outcomes

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

    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).

    Time frame: Baseline and Week 26

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

    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.

    Time frame: Baseline and Week 26

Secondary outcomes

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

    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

    Time frame: Baseline and Week 26

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

    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).

    Time frame: Baseline and Week 26

Other outcomes

  1. Percent Change From Baseline in P1NP at Week 13

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

    Time frame: Baseline and Week 13

  2. Percent Change From Baseline in CTX at Week 13

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

    Time frame: Baseline and Week 13

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

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

    Time frame: Baseline and Week 26

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

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

    Time frame: Baseline and Week 26

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

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

    Time frame: Baseline and Week 26

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

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

    Time frame: Week 26 and Week 52

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

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

    Time frame: Week 26 and Week 52

  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

07

Results

Posted Mar 18, 2024

Participant flow

Participants took part in the study at 10 investigative sites in the United States from 01 November 2010 (first subject signed informed consent form) to 1 February 2015.

Main Study
Participant flow — Main Study
MilestonePlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Started423835
Safety set: received study drug413835
Randomized, not treated100
Completed343029
Not completed886
Withdrew: Adverse event142
Withdrew: Major protocol deviation101
Withdrew: Lost to follow-up310
Withdrew: Voluntary withdrawal222
Withdrew: Other reason not specified011
Withdrew: Randomized, not treated100
Calcium Absorption Substudy
Participant flow — Calcium Absorption Substudy
MilestonePlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Started141010
Safety set: received study drug141010
Completed12810
Not completed220
Withdrew: Adverse event020
Withdrew: Major protocol deviation100
Withdrew: Voluntary withdrawal100

Outcome measures

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

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).

Time frame:
Baseline and Week 26
Reported as:
Median · percent change
Percent Change From Baseline to Week 26 in Bone Formation Marker Aminoterminal Propeptide of Type 1 Collagen (P1NP)
percent changePlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Percent Change From Baseline to Week 26 in Bone Formation Marker Aminoterminal Propeptide of Type 1 Collagen (P1NP)-0.4 (-35 to 75)19.3 (-33 to 82)16.9 (-8 to 73)
Statistical analysis
  • Placebo vs Dexlansoprazole 60 mg · Difference: 19.2 · 95% CI 7.0 to 30.2Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.
  • Placebo vs Esomeprazole 40 mg · Difference: 18.2 · 95% CI 6.7 to 30.4Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.
PrimaryPercent Change From Baseline to Week 26 in Bone Resorption Marker C-telopeptide of Collagen Cross-links (CTX)

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.

Time frame:
Baseline and Week 26
Reported as:
Median · percent change
Percent Change From Baseline to Week 26 in Bone Resorption Marker C-telopeptide of Collagen Cross-links (CTX)
percent changePlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Percent Change From Baseline to Week 26 in Bone Resorption Marker C-telopeptide of Collagen Cross-links (CTX)2.441 (-65.59 to 54.55)29.524 (-28.81 to 171.74)23.897 (-21.90 to 110.53)
Statistical analysis
  • Placebo vs Dexlansoprazole 60 mg · Difference: 27.366 · 95% CI 12.749 to 42.957Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.
  • Placebo vs Esomeprazole 40 mg · Difference: 22.025 · 95% CI 8.357 to 35.714Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.
SecondaryPercent Change From Baseline to Week 26 in Urine N-telopeptide of Collagen Cross-links (NTx) Calculated

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

Time frame:
Baseline and Week 26
Reported as:
Median · percent change
Percent Change From Baseline to Week 26 in Urine N-telopeptide of Collagen Cross-links (NTx) Calculated
percent changePlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Percent Change From Baseline to Week 26 in Urine N-telopeptide of Collagen Cross-links (NTx) Calculated-6.1 (-53 to 86)16.9 (-45 to 100)6.2 (-45 to 67)
Statistical analysis
  • Placebo vs Dexlansoprazole 60 mg · Difference: 20.1 · 95% CI 4.0 to 34.4Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.
  • Placebo vs Esomeprazole 40 mg · Difference: 11.6 · 95% CI -2.7 to 28.3Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.
SecondaryPercent Change From Baseline to Week 26 in Bone-specific Alkaline Phosphatase (BsAP)

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).

Time frame:
Baseline and Week 26
Reported as:
Median · percent change
Percent Change From Baseline to Week 26 in Bone-specific Alkaline Phosphatase (BsAP)
percent changePlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Percent Change From Baseline to Week 26 in Bone-specific Alkaline Phosphatase (BsAP)0.50 (-22.7 to 27.2)8.68 (-14.6 to 36.2)6.23 (-13.5 to 48.0)
Statistical analysis
  • Placebo vs Dexlansoprazole 60 mg · Difference: 6.83 · 95% CI 0.40 to 12.78Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.
  • Placebo vs Esomeprazole 40 mg · Difference: 7.23 · 95% CI 0.59 to 12.86Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.
Other pre-specifiedPercent Change From Baseline in P1NP at Week 13

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

Time frame:
Baseline and Week 13
Reported as:
Mean · percent change
Percent Change From Baseline in P1NP at Week 13
percent changePlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Percent Change From Baseline in P1NP at Week 136.7 ± 18.2719.1 ± 25.0211.6 ± 18.23
Other pre-specifiedPercent Change From Baseline in CTX at Week 13

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

Time frame:
Baseline and Week 13
Reported as:
Mean · percent change
Percent Change From Baseline in CTX at Week 13
percent changePlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Percent Change From Baseline in CTX at Week 137.510 ± 29.973932.069 ± 45.641323.212 ± 23.8900
Other pre-specifiedPercent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 26

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

Time frame:
Baseline and Week 26
Reported as:
Mean · percent change
Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 26
percent changePlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 26-0.6632 ± 2.48314-1.6039 ± 2.58207-1.0596 ± 2.41731
Other pre-specifiedPercent Change From Baseline in Total Hip BMD Measured by DXA at Week 26

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

Time frame:
Baseline and Week 26
Reported as:
Mean · percent change
Percent Change From Baseline in Total Hip BMD Measured by DXA at Week 26
percent changePlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Percent Change From Baseline in Total Hip BMD Measured by DXA at Week 26-0.1928 ± 1.42242-0.7190 ± 1.78479-0.5330 ± 1.50491
Other pre-specifiedPercent Change From Baseline in Lumbar Spine BMD Measured by DXA at Week 26

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

Time frame:
Baseline and Week 26
Reported as:
Mean · percent change
Percent Change From Baseline in Lumbar Spine BMD Measured by DXA at Week 26
percent changePlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Percent Change From Baseline in Lumbar Spine BMD Measured by DXA at Week 26-0.2486 ± 3.29581-1.0753 ± 3.46909-1.2873 ± 2.06722
Other pre-specifiedPercent Change From Week 26 in Femoral Neck BMD Measured by DXA at Week 52

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

Time frame:
Week 26 and Week 52
Reported as:
Mean · percent change
Percent Change From Week 26 in Femoral Neck BMD Measured by DXA at Week 52
percent changePlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Percent Change From Week 26 in Femoral Neck BMD Measured by DXA at Week 52-0.0063 ± 2.57407-0.3439 ± 2.396800.2689 ± 2.67283
Other pre-specifiedPercent Change From Weeks 26 in Total Hip BMD Measured by DXA at Week 52

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

Time frame:
Week 26 and Week 52
Reported as:
Mean · percent change
Percent Change From Weeks 26 in Total Hip BMD Measured by DXA at Week 52
percent changePlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Percent Change From Weeks 26 in Total Hip BMD Measured by DXA at Week 52-0.0201 ± 1.28096-0.3324 ± 1.58091-0.0799 ± 1.81755
Other pre-specifiedPercent Change From Weeks 26 in Lumbar Spine BMD Measured by DXA at Week 52
Time frame:
Week 26 and Week 52
Reported as:
Mean · percent change
Percent Change From Weeks 26 in Lumbar Spine BMD Measured by DXA at Week 52
percent changePlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Percent Change From Weeks 26 in Lumbar Spine BMD Measured by DXA at Week 52-0.4913 ± 3.01161-0.3561 ± 2.429340.8565 ± 2.46230
Other pre-specifiedNumber of Participants With Fracture Including Vertebral Fracture During Study Treatment
Time frame:
Baseline up to Week 26
Reported as:
Number · participants
Number of Participants With Fracture Including Vertebral Fracture During Study Treatment
participantsPlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Number of Participants With Fracture Including Vertebral Fracture During Study Treatment000
Other pre-specifiedChange From Baseline in 24-hour Urinary Calcium Excretion at Week 26
Time frame:
Baseline and Week 26
Reported as:
Mean · milligram per day (mg/d)
Change From Baseline in 24-hour Urinary Calcium Excretion at Week 26
milligram per day (mg/d)PlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Baseline160.3 ± 76.16184.8 ± 79.52153.7 ± 90.09
Change at Week 26-24.4 ± 87.16-50.6 ± 84.95-49.7 ± 94.38
Other pre-specifiedChange From Baseline in Parathyroid Hormone (PTH) at Week 26
Time frame:
Baseline and Week 26
Reported as:
Mean · picogram per milliliter (pg/mL)
Change From Baseline in Parathyroid Hormone (PTH) at Week 26
picogram per milliliter (pg/mL)PlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Baseline30.67 ± 10.06830.68 ± 11.91731.10 ± 8.254
Change at Week 262.16 ± 7.7932.08 ± 7.7653.37 ± 9.525
Other pre-specifiedChange From Baseline in Serum Calcium at Week 26
Time frame:
Baseline and Week 26
Reported as:
Mean · milligram per deciliter (mg/dL)
Change From Baseline in Serum Calcium at Week 26
milligram per deciliter (mg/dL)PlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Baseline9.48 ± 0.3479.47 ± 0.2919.58 ± 0.308
Change at Week 26-0.03 ± 0.440-0.03 ± 0.333-0.07 ± 0.331
Other pre-specifiedChange From Baseline in Serum Phosphorus at Week 26
Time frame:
Baseline and Week 26
Reported as:
Mean · mg/dL
Change From Baseline in Serum Phosphorus at Week 26
mg/dLPlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Baseline3.73 ± 0.3773.92 ± 0.4223.89 ± 0.335
Change at Week 260.08 ± 0.4450.07 ± 0.2710.03 ± 0.393
Other pre-specifiedChange From Baseline in Serum Magnesium at Week 26
Time frame:
Baseline and Week 26
Reported as:
Mean · milliequivalent per liter (meq/L)
Change From Baseline in Serum Magnesium at Week 26
milliequivalent per liter (meq/L)PlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Baseline1.72 ± 0.1241.72 ± 0.1451.77 ± 0.127
Change at Week 26-0.01 ± 0.118-0.02 ± 0.109-0.03 ± 0.096
Other pre-specifiedChange From Baseline in Urine Magnesium at Week 26
Time frame:
Baseline and Week 26
Reported as:
Mean · meq/L
Change From Baseline in Urine Magnesium at Week 26
meq/LPlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Baseline3.8 ± 2.114.6 ± 3.464.1 ± 2.85
Change at Week 26-0.1 ± 2.41-0.8 ± 2.83-0.5 ± 2.80
Other pre-specifiedChange From Baseline to Week 26 in Vitamin D3 (25-OH-D) Level
Time frame:
Baseline and Week 26
Reported as:
Mean · ng/mL
Change From Baseline to Week 26 in Vitamin D3 (25-OH-D) Level
ng/mLPlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Baseline41.3 ± 9.9639.4 ± 11.6436.4 ± 8.48
Change at Week 26-2.7 ± 10.20-0.6 ± 12.071.1 ± 9.75
Other pre-specifiedChange 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
Reported as:
Mean · mg/d
Change From Baseline in Intestinal Calcium Absorption by True Fractional Calcium Absorption (TFCA) in a Subset of Participants at Week 26
mg/dPlaceboDexlansoprazole 60 mgEsomeprazole 40 mg
Baseline0.18 ± 0.0640.18 ± 0.0430.17 ± 0.049
Change at week 26-0.01 ± 0.0490.02 ± 0.0420.05 ± 0.050

Adverse events

Collected over First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/41 (0%)0/41 (0%)6/41 (14.6%)
Dexlansoprazole 60 mg0/38 (0%)1/38 (2.6%)8/38 (21.1%)
Esomeprazole 40mg0/35 (0%)0/35 (0%)9/35 (25.7%)
Calcium Absorption Sub Study: Placebo0/14 (0%)0/14 (0%)3/14 (21.4%)
Calcium Absorption Sub Study: Dexlansoprazole 60 mg0/10 (0%)0/10 (0%)4/10 (40%)
Calcium Absorption Sub Study: Esomeprazole 40 mg0/10 (0%)0/10 (0%)5/10 (50%)
Most frequent serious events
Most frequent serious events
EventPlaceboDexlansoprazole 60 mgEsomeprazole 40mgCalcium Absorption Sub Study: PlaceboCalcium Absorption Sub Study: Dexlansoprazole 60 mgCalcium Absorption Sub Study: Esomeprazole 40 mg
NephrolithiasisRenal and urinary disorders0/411/380/350/140/100/10
Most frequent other events
Most frequent other events
EventPlaceboDexlansoprazole 60 mgEsomeprazole 40mgCalcium Absorption Sub Study: PlaceboCalcium Absorption Sub Study: Dexlansoprazole 60 mgCalcium Absorption Sub Study: Esomeprazole 40 mg
DiarrhoeaGastrointestinal disorders3/416/381/351/143/100/10
DyspepsiaGastrointestinal disorders0/411/383/350/140/103/10
Urinary tract infectionInfections and infestations0/410/385/350/140/102/10
Upper respiratory tract infectionInfections and infestations3/411/382/352/141/102/10

Baseline characteristics

Safety set includes all randomized participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)PlaceboDexlansoprazole 60 mgEsomeprazole 40 mgTotal
Mean61.2 (51 to 73)62.4 (52 to 75)63.2 (54 to 74)62.2 (51 to 75)
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboDexlansoprazole 60 mgEsomeprazole 40 mgTotal
Female413835114
Male0000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboDexlansoprazole 60 mgEsomeprazole 40 mgTotal
Hispanic or Latino35311
Not Hispanic or Latino383332103
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboDexlansoprazole 60 mgEsomeprazole 40 mgTotal
American Indian or Alaska Native1001
Asian0202
Native Hawaiian or Other Pacific Islander0000
Black or African American2226
White373433104
More than one race1001
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(Participants)PlaceboDexlansoprazole 60 mgEsomeprazole 40 mgTotal
United States413835114
Height
Height(cm)PlaceboDexlansoprazole 60 mgEsomeprazole 40 mgTotal
Mean164.4 (153 to 175)164.9 (154 to 178)164.6 (152 to 180)164.6 (152 to 180)
Weight
Weight(kg)PlaceboDexlansoprazole 60 mgEsomeprazole 40 mgTotal
Mean69.25 (54.4 to 87.7)66.54 (51.4 to 92.0)69.47 (55.4 to 97.5)68.1 (51.4 to 97.5)
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)PlaceboDexlansoprazole 60 mgEsomeprazole 40 mgTotal
Mean25.61 (21.3 to 30.9)24.46 (18.2 to 31.3)25.65 (19.6 to 30.7)25.24 (18.2 to 31.3)

5 further baseline measures are reported on the registry.

08

Study locations

12 sites
  • San Diego, California, United States
  • Walnut Creek, California, United States
  • Lakewood, Colorado, United States
  • Hialeah, Florida, United States
  • Jupiter, Florida, United States
  • Bethesda, Maryland, United States
  • Albuquerque, New Mexico, United States
  • Spartanburg, South Carolina, United States
  • Austin, Texas, United States
  • San Antonio, Texas, United States
  • Seattle, Washington, United States
  • Madison, Wisconsin, United States
09

References and documents

Publications

  • Hansen KE, Nieves JW, Nudurupati S, Metz DC, Perez MC. Dexlansoprazole and Esomeprazole Do Not Affect Bone Homeostasis in Healthy Postmenopausal Women. Gastroenterology. 2019 Mar;156(4):926-934.e6. doi: 10.1053/j.gastro.2018.11.023. Epub 2018 Nov 13. PubMed 30445008 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01216293
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Oct 7, 2010
Start date
Nov 1, 2010
Primary completion
Aug 1, 2014
Completion
Feb 1, 2015
Results posted
Mar 18, 2024
Last update
Mar 18, 2024

Study contacts

Medical Director Clinical Science
study director · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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