Trial Outcomes & Findings for Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption? (NCT NCT00766532)

Results Overview

intestinal calcium absorption

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

baseline and 6 weeks later

Results posted on

2012-09-14

Participant Flow

Postmenopausal women with early stage breast cancer and planning to start aromatase inhibitor therapy.

Participants completed a four-day food diary

Participant milestones

Participant milestones
Measure	Arm Title- Aromatase Inhibitor Therapy calcium absorption was measured among subjects at baseline and after taking aromatase inhibitor therapy.
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm Title- Aromatase Inhibitor Therapy calcium absorption was measured among subjects at baseline and after taking aromatase inhibitor therapy.
Overall Study Protocol Violation	2

Baseline Characteristics

Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=12 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=93 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants
Age Continuous	66 years STANDARD_DEVIATION 7 • n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	12 participants n=93 Participants

PRIMARY outcome

Timeframe: baseline and 6 weeks later

Population: 12 subjects provided informed consent but two dropped and did not undergo calcium absorption study visits. 10 subjects completed all calcium absorption study visits.

intestinal calcium absorption

Outcome measures

Outcome measures
Measure	Aromatase Inhibitor Therapy n=10 Participants
Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy	16 percent calcium absorption Standard Deviation 6

Adverse Events

Group 1

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: 608-263-0517

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place