RANKL Inhibition and Mammographic Breast Density

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

August 27, 2019

Primary Completion Date

September 25, 2025

Study Completion Date

August 31, 2026

Conditions
Dense Breasts
Interventions
DRUG

Denosumab

Denosumab is commercially available and will be provided at no cost to participants.

DRUG

Placebo

Placebo will be made available as 1 mL sterile, non-pyrogenic water solution in a single-use prefilled syringe.

DRUG

Calcium

-Participants will be instructed to take calcium (at least 500 mg) daily for 12 months between baseline examination and 12- month mammographic breast density examination.

DRUG

Vitamin D3

Participants will be instructed to take vitamin D3 (at least 400 IU) supplements daily for 12 months between baseline examination and 12- month mammographic breast density examination.

PROCEDURE

Core needle biopsy

Baseline and 12 months

PROCEDURE

Blood draw

Baseline and 12 months

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

lead

Washington University School of Medicine

OTHER