Trial Outcomes & Findings for Denosumab and MRI Breast Imaging (NCT NCT02613416)

NCT ID: NCT02613416

Last Updated: 2024-08-23

Results Overview

Breast density will be measured via non-contrast MRI before and after 6 months on denosumab

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: baseline, 6 months
• Results posted on: 2024-08-23

Participant Flow

12 consented patients were determined to be eligible but withdrew consent before the start of the study intervention

Participant milestones

Measure	Denosumab 120 mg Subcutaneous 6 monthly subcutaneous injections of denosumab Denosumab: monthly subcutaneous injections
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Denosumab and MRI Breast Imaging

Baseline characteristics by cohort

Measure	Denosumab n=30 Participants 6 monthly subcutaneous injections of denosumab Denosumab: monthly subcutaneous injections
Age, Continuous	59.5 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants
Percentage of Breast Density by Magnetic Resonance Imaging	19.74 percent n=5 Participants

PRIMARY outcome

Timeframe: baseline, 6 months

Population: 5 subjects were excluded (ineligible (n=1), withdrew consent (n=1), implants both breasts (n=1) and image artifacts (n=2).

Breast density will be measured via non-contrast MRI before and after 6 months on denosumab

Outcome measures

Measure	Denosumab 120 mg Subcutaneous n=25 Participants 6 monthly subcutaneous injections of denosumab Denosumab: monthly subcutaneous injections
Relative Change of ≥ 5% in Breast Density at 6 Months Decrease in breast density of ≥ 5% at 6 months	13 Participants
Relative Change of ≥ 5% in Breast Density at 6 Months No change in breast density	8 Participants
Relative Change of ≥ 5% in Breast Density at 6 Months Increase in breast density of ≥ 5% at 6 months density	4 Participants

SECONDARY outcome

Timeframe: 6 months

Unadjusted Absolute Change > 1% in breast density

Outcome measures

Measure	Denosumab 120 mg Subcutaneous n=25 Participants 6 monthly subcutaneous injections of denosumab Denosumab: monthly subcutaneous injections
Absolute Change > 1% in Breast Density >1% decrease in breast density	13 Participants
Absolute Change > 1% in Breast Density no change in breast density	8 Participants
Absolute Change > 1% in Breast Density >1% increase in breast density	4 Participants

Adverse Events

Denosumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Caterina Vacchi-Suzzi

Stony Brook University

Phone: 631-444-8074

Email: caterina.vacchi-suzzi@stonybrookmedicine.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place