210
Participants
Start Date
August 27, 2019
Primary Completion Date
September 25, 2025
Study Completion Date
August 31, 2026
Denosumab
Denosumab is commercially available and will be provided at no cost to participants.
Placebo
Placebo will be made available as 1 mL sterile, non-pyrogenic water solution in a single-use prefilled syringe.
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.
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.
Core needle biopsy
Baseline and 12 months
Blood draw
Baseline and 12 months
Washington University School of Medicine, St Louis
National Institutes of Health (NIH)
NIH
Washington University School of Medicine
OTHER