Effect of Aromatase Inhibitors on Bones and Genes

NCT00603967 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2013-05-24

No results posted yet for this study

Summary

The primary objective of this 2-year pilot project is to test the hypothesis that skeletal response to aromatase inhibitors is determined by polymorphisms of the CYP19 gene.

Conditions

Interventions

PROCEDURE

Dual x-ray absorptiometry (DXA)

Baseline, 6 months, and 12 months

PROCEDURE

Blood draw

Baseline - genotyping Baseline, 6 months, and 12 months - markers of bone turnover and hormonal assays

BEHAVIORAL

Questionnaire

Menopausal symptom questionnaire - baseline, 3 months, 6 months, 12 months Cognitive tests - baseline, 6 months, 12 months Depression assessment - baseline, 6 months, 12 months Dietary calcium intake questionnaire - baseline

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Antonella Rastelli, MD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00603967 on ClinicalTrials.gov