NCT00582972

Brief Summary

The purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2007

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 21, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

11 months

First QC Date

December 19, 2007

Results QC Date

July 6, 2012

Last Update Submit

February 14, 2013

Conditions

OsteoporosisAchlorhydriaGERDHip Fracture

Keywords

Calcium AbsorptionFractional Calcium AbsorptionOmeprazoleStable Calcium IsotopesProton Pump InhibitorIntestinal Absorption of Calcium

Outcome Measures

Primary Outcomes (1)

  • Change in Intestinal Calcium Absorption From Baseline to One Month

    percent calcium absorption

    change in calcium absorption from baseline to 1 month

Secondary Outcomes (1)

  • Change in Bone Resorption From Baseline to 1 Month

    change in bone resorption from baseline to 1 month

Study Arms (1)

Experimental

EXPERIMENTAL

Subjects will receive omeprazole 40 mg daily for 30 days

Drug: Omeprazole

Interventions

OmeprazoleDRUG

40 mg po qAM one-half hour before breakfast for 30 days

Also known as: Losec, Prilosec
Experimental

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women at least 5 years past menopause, defined as the last date of menses

You may not qualify if:

  • Allergy/Intolerance to orange juice
  • Allergy/Intolerance to omeprazole or other PPI therapy
  • Use of drugs that interact with omeprazole including oral anti-fungal agents, coumadin, diazepam, phenytoin \& tacrolimus
  • Use of antacids, PPI or H2-blocker therapy within the past two months
  • Intestinal conditions associated with malabsorption or low gastric acid levels including Crohn's Disease, ulcerative colitis, pernicious anemia, bacterial overgrowth, celiac sprue, chronic diarrhea or use of antibiotics within the past month
  • Known Stage 4 or 5 Chronic Kidney Disease, defined as an estimated GFR \<30 cc/minute
  • Use of medications known to interfere with calcium metabolism, including oral steroids or anticonvulsants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

  • Hansen KE, Jones AN, Lindstrom MJ, Davis LA, Ziegler TE, Penniston KL, Alvig AL, Shafer MM. Do proton pump inhibitors decrease calcium absorption? J Bone Miner Res. 2010 Dec;25(12):2786-95. doi: 10.1002/jbmr.166. Epub 2010 Jun 24.

    PMID: 20578215RESULT

  • Jones AN, Shafer MM, Keuler NS, Crone EM, Hansen KE. Fasting and postprandial spot urine calcium-to-creatinine ratios do not detect hypercalciuria. Osteoporos Int. 2012 Feb;23(2):553-62. doi: 10.1007/s00198-011-1580-7. Epub 2011 Feb 24.

    PMID: 21347742RESULT

MeSH Terms

Conditions

OsteoporosisAchlorhydriaGastroesophageal RefluxHip Fractures

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesStomach DiseasesGastrointestinal DiseasesDigestive System DiseasesAcid-Base ImbalanceEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Dr. Karen Hansen
Organization
University of Wisconsin
keh@medicine.wisc.edu
608-263-3457

Study Officials

  • Karen E Hansen, MD

    Univeristy of Wisconsin School of Medicine and Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 28, 2007

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2010

Last Updated

February 15, 2013

Results First Posted

January 21, 2013

Record last verified: 2013-02

Locations

US(1)