MedTrace Logo

Effect of Denosumab on Cellular Biomarkers in the Human Breast

NCT02099461 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2015-09-24

Study results available
· View outcomes & findings →

Summary

To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.

Conditions

  • Healthy Volunteer, Female, Breast

Interventions

DRUG

Denosumab

Single sucutaneous dose

PROCEDURE

Percutaneous core needle breast biopsy

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02099461 on ClinicalTrials.gov