Conditions: Healthy Volunteer, Female, Breast
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 82
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28. arm 2: Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 (prior to study treatment) and Day 28. arm 3: Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 (prior to study treatment) and Day 28.

Interventions: intervention 1: Denosumab intervention 2: Percutaneous core needle breast biopsy
Intervention descriptions: intervention 1: Single sucutaneous dose intervention 2: None

Protocol document: