Trial Outcomes & Findings for Does Omeprazole Decrease Intestinal Calcium Absorption? (NCT NCT00582972)

NCT ID: NCT00582972

Last Updated: 2013-02-15

Results Overview

percent calcium absorption

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 23 participants
• Primary outcome timeframe: change in calcium absorption from baseline to 1 month
• Results posted on: 2013-02-15

Participant Flow

At least 5 years past onset of menopause; not taking proton pump inhibitors

subjects completed a food diary

Participant milestones

Measure	Experimental Subjects will receive omeprazole 40 mg daily for 30 days
Overall Study STARTED	23
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Experimental Subjects will receive omeprazole 40 mg daily for 30 days
Overall Study Protocol Violation	2

Baseline Characteristics

Does Omeprazole Decrease Intestinal Calcium Absorption?

Baseline characteristics by cohort

Measure	Experimental n=23 Participants Subjects will receive omeprazole 40 mg daily for 30 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	58 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: change in calcium absorption from baseline to 1 month

Population: Subjects completing the measures of calcium absorption were included in the analysis of the primary outcome.

percent calcium absorption

Outcome measures

Measure	Experimental n=21 Participants omeprazole 40 mg daily for 30 days
Change in Intestinal Calcium Absorption From Baseline to One Month	5 percent calcium absorption Standard Deviation 10

SECONDARY outcome

Timeframe: change in bone resorption from baseline to 1 month

Population: 23 enrolled but two dropped from the study, leading to 21 subjects who completed all study visits

urine n-telopeptide (normalized to creatinine levels)

Outcome measures

Measure	Experimental n=21 Participants omeprazole 40 mg daily for 30 days
Change in Bone Resorption From Baseline to 1 Month	1.9 mcg/mmol creatinine Standard Deviation 0.9

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Karen Hansen

University of Wisconsin

Phone: 608-263-3457

Email: keh@medicine.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place