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RANKL Inhibition and Mammographic Breast Density

NCT04067726 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-03-31

No results posted yet for this study

Summary

Data supporting a role for RANKL signaling in mammographic density and breast cancer development has begun to emerge, but clinical trial data providing definitive evidence that would allow the adoption of RANKL inhibition in primary breast cancer prevention are not yet available. The hypothesis is that RANKL inhibition with denosumab will decrease mammographic density in high-risk premenopausal women with dense breasts. To address this, the investigators have developed this clinical trial to quantify the impact of RANKL inhibition on mammographic density in high-risk premenopausal women with dense breasts and to determine the effect of RANKL inhibition on markers of proliferation and biomarkers of breast cancer risk. Successful demonstration that RANKL inhibition reduces mammographic density could open up additional approaches to primary breast cancer prevention in high-risk premenopausal women, who do not have dominant genetic predisposition.

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Adetunji T Toriola, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-27
Primary Completion
2025-09-17
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT04067726 on ClinicalTrials.gov