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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 9, 2026
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Phase 2 Trial.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT04067726). This is a study registration, not published results. Lead sponsor: Washington University School of Medicine. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 210 participants (ACTUAL). Conditions: Dense Breasts. Interventions: DRUG: Denosumab; DRUG: Placebo; DRUG: Calcium; DRUG: Vitamin D3; PROCEDURE: Core needle biopsy; PROCEDURE: Blood draw. Primary outcome measures: Percent Change of Volumetric Percent Density Compared Between Baseline and 12 Months , At baseline and at 12 months. Brief 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.