CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 12 enrolled
Drug / intervention
Aromatase Inhibitordrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00766532
NCT00766532Phase 4Completed

Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?

University of Wisconsin, Madison·interventional·Posted Oct 6, 2008·Updated Sep 14, 2012

In Brief

A Phase 4 clinical trial evaluating Aromatase Inhibitor for Breast Cancer and 3 related conditions. Completed, enrolled 12 participants.

Detailed Summary

Research Question: Do Aromatase Inhibitors Decrease Intestinal Calcium Absorption? Study Design: Postmenopausal women with early stage breast cancer initiating aromatase inhibitor adjuvant therapy will participate in this two-month study. The primary study outcome is the change in intestinal calcium absorption following such therapy. Secondary outcomes are the changes in bone resorption markers and musculoskeletal signs and symptoms after initiation of therapy. We will interview women and review their medical records to determine eligibility. Eligible subjects will undergo two calcium absorption studies. The first study will determine their baseline calcium absorption, and the second study will occur after taking an aromatase inhibitor daily for at least 6 weeks. Women will present to the research unit in the early morning and receive an oral and intravenous stable calcium tracer with breakfast. Over the next 24 hours, we will collect all urine for measurement of its calcium content. During each inpatient stay, we will assess musculoskeletal symptoms by questionnaire and joint examination. Each woman will complete a four-day diet diary twice during the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2008
Enrollment StartJan 1, 2009
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.7 years ago

Interventions

Aromatase Inhibitordrug

Any aromatase inhibitor started as initial adjuvant therapy