NCT02099461

Effect of Denosumab on Cellular Biomarkers in the Human Breast

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer, Female, Breast

Interventions

Type	Name	Description
DRUG	Denosumab	Single sucutaneous dose
PROCEDURE	Percutaneous core needle breast biopsy

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-03-31
• Last updated: 2015-09-24
• Results posted: 2015-09-24

Locations

3 sites across 1 country: United States