At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 82 enrolled
Drug / intervention
Denosumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Stratified, Open-label, No-treatment-controlled, Parallel Group, Multicenter Phase 1 Trial to Evaluate the Effect of Denosumab on Cellular Proliferation in the Human Breast
In Brief
A Phase 1 clinical trial evaluating Denosumab and Percutaneous core needle breast biopsy for Healthy Volunteer, Female, Breast. Completed, enrolled 82 participants across 3 sites.
Detailed Summary
To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer, Female, Breast
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartApr 2014
Primary CompletionJul 2014
TodayJul 2026
First PostedMar 31, 2014
Enrollment StartApr 1, 2014
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.3 years ago
Interventions
Denosumabdrug
Single sucutaneous dose
Percutaneous core needle breast biopsyprocedure