Effect of Dexlansoprazole on Bone Homeostasis

NCT01216293 | Completed Phase 1 Results

• 2 other identifiers: TAK-390MR_104U1111-1116-1638
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Homeostasis; Bone and Bones

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline and Week 26

• 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.

  Baseline and Week 26

Secondary Outcomes (2)

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

  Baseline and Week 26

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

  Baseline and Week 26

Other Outcomes (17)

• Percent Change From Baseline in P1NP at Week 13

  Baseline and Week 13

• Percent Change From Baseline in CTX at Week 13

  Baseline and Week 13

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

  Baseline and Week 26

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Dexlansoprazole 60 mg

EXPERIMENTAL

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

Esomeprazole 40mg

ACTIVE COMPARATOR

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

Dexlansoprazole DRUG

Dexlansoprazole 60 mg capsules

Also known as: Dexilant, Kapidex

Dexlansoprazole 60 mg

Esomeprazole DRUG

Esomeprazole 40 mg capsules

Also known as: Nexium

Esomeprazole 40mg

Placebo DRUG

Placebo-matching capsules

Placebo

Eligibility Criteria

• Age: Up to 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (12)

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Walnut Creek, California, United States

Location

Unknown Facility

Lakewood, Colorado, United States

Location

Unknown Facility

Hialeah, Florida, United States

Location

Unknown Facility

Jupiter, Florida, United States

Location

Unknown Facility

Bethesda, Maryland, United States

Location

Unknown Facility

Albuquerque, New Mexico, United States

Location

Unknown Facility

Spartanburg, South Carolina, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

Related Publications (1)

• 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.

  PMID: 30445008 DERIVED

Related Links

• Dexilant Package Insert

MeSH Terms

Interventions

Dexlansoprazole; Lansoprazole; Esomeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Omeprazole

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 7, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: February 1, 2015
• Last Updated: March 18, 2024
• Results First Posted: March 18, 2024

Record last verified: 2023-09

Locations

US (12)