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NCT03629717 · ClinicalTrials.gov registry record · Early Phase 1
RANKL Inhibition and Breast Tissue Biomarkers
A Early Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT03629717: Completed Early Phase 1 study, sponsored by Washington University School of Medicine.
NCT03629717 is a Early Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03629717, a Early Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
A robust knowledge of how to reduce breast density could play a key role in breast cancer prevention in premenopausal women, but viable preventative targets to reduce breast density-associated breast cancer risk are yet to be developed. The investigators propose to investigate the effect of RANKL inhibition with denosumab on breast tissue markers in high-risk premenopausal women with dense breasts. Study findings could provide robust evidence to move forward with a clinical trial targeting RANKL inhibition in premenopausal breast cancer prevention.
Primary Outcome
The investigators will evaluate changes in pathway gene expression between baseline and day 60 using NanoString NCounter platform
Interventions
- PROCEDURE Blood draw
- DRUG Denosumab
- DRUG Calcium
- DRUG Vitamin D
- PROCEDURE Ultrasound-guided core needle biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-06-01 |
| Est. Completion | 2018-12-03 |
| Phase | Early Phase 1 |
What the finished NCT03629717 record still lists
NCT03629717 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 5 interventions - of which Blood draw is the first listed.
NCT03629717 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03629717 about?
NCT03629717 is a clinical study titled "RANKL Inhibition and Breast Tissue Biomarkers". A robust knowledge of how to reduce breast density could play a key role in breast cancer prevention in premenopausal women, but viable preventative targets to reduce breast density-associated breast cancer risk are yet to be developed. The investigators propose to investigate the effect of RANKL in...
What is the current status of trial NCT03629717?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2018-06-01. Estimated completion is 2018-12-03.
What interventions are being tested in trial NCT03629717?
The interventions under investigation include: Blood draw (PROCEDURE), Denosumab (DRUG), Calcium (DRUG), Vitamin D (DRUG), Ultrasound-guided core needle biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT03629717?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03629717's enrollment target sits among peer trials
10 1629th of 2000 higher than 256 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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