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Trial record 4 of 4 for:    "Achlorhydria"

Does Omeprazole Decrease Intestinal Calcium Absorption?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00582972
First received: December 19, 2007
Last updated: February 14, 2013
Last verified: February 2013
Results First Received: July 6, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Osteoporosis
Achlorhydria
GERD
Hip Fracture
Intervention: Drug: Omeprazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
At least 5 years past onset of menopause; not taking proton pump inhibitors

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
subjects completed a food diary

Reporting Groups
  Description
Experimental Subjects will receive omeprazole 40 mg daily for 30 days

Participant Flow:   Overall Study
    Experimental
STARTED   23 
COMPLETED   21 
NOT COMPLETED   2 
Protocol Violation                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Experimental Subjects will receive omeprazole 40 mg daily for 30 days

Baseline Measures
   Experimental 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   23 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 58  (7) 
Gender 
[Units: Participants]
 
Female   23 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   23 


  Outcome Measures
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1.  Primary:   Change in Intestinal Calcium Absorption From Baseline to One Month   [ Time Frame: change in calcium absorption from baseline to 1 month ]

2.  Secondary:   Change in Bone Resorption From Baseline to 1 Month   [ Time Frame: change in bone resorption from baseline to 1 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Karen Hansen
Organization: University of Wisconsin
phone: 608-263-3457
e-mail: keh@medicine.wisc.edu


Publications of Results:

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582972     History of Changes
Other Study ID Numbers: H-2007-0179
07-1235-03
Study First Received: December 19, 2007
Results First Received: July 6, 2012
Last Updated: February 14, 2013