Could a bone drug make dense breasts less Cancer-Prone?
NCT ID NCT04067726
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether denosumab, a drug that blocks RANKL signaling, can reduce mammographic breast density in premenopausal women with dense breasts. Dense breasts are a known risk factor for breast cancer. The study involves 210 women who will receive either denosumab or a placebo for one year, along with calcium and vitamin D. The main goal is to see if the drug lowers breast density, which could lead to new prevention strategies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Denosumab (a drug that blocks RANKL signaling, also used for osteoporosis)
- What this could lead to
- If it works, this could point toward a new way to prevent breast cancer in high-risk premenopausal women with dense breasts.
- What could go wrong
- This is an early phase 2 trial with only 210 participants, so results may not apply broadly. Denosumab can cause side effects like low calcium levels and jaw problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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210 people
The number who actually took part.
- Started
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Aug 2019
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Female. * Premenopausal (when menopausal status is uncertain, the investigators will measure follicle-stimulating hormone and estradiol to ascertain that a partcipant is premenopausal) * At least 40 years of age. * Dense breasts on routine mammogram (BI-RADS Category C and D) * Able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: * History of breast or any other invasive cancer except for DCIS (ductal carcinoma in situ) who received only lumpectomy, LCIS (lobular carcinoma in situ), atypical hyperplasia, non-melanoma skin cancer, carcinoma in situ of the cervix. * Current use of tamoxifen, aromatase inhibitors, or bisphosphonates, or RANKL inhibitors * Concurrent participation in another cancer chemoprevention trial (unless no longer receiving the intervention). * Pregnant, lactating, or planning to get pregnant while the trial is ongoing. * Recent history of invasive dental procedure (e.g. tooth extraction, dental implant, oral surgery). * Unhealed and/or planned dental/oral surgery. * History of osteonecrosis/osteomyelitis of the jaw. * History of osteoporosis or severe osteopenia.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Washington University School of Medicine
St Louis, Missouri, 63110, United States