Denosumab for Dense Breasts

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Dense BreastsDenosumab - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial will test whether or not a drug that inhibits RANKL decreases mammographic density in high-risk premenopausal women with dense breasts, which could lead to new ways to prevent breast cancer.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

0 Primary · 1 Secondary · Reporting Duration: From 12 months to 24 months

Baseline
Correlations between gene expression within the breast tissue and within the blood
Baseline and 12 months
Change in expression of RANKL pathway genes compared between the two arms
Change in expression of immune markers compared between the two arms
Change in expression of inflammatory markers compared between the two arms
Change in expression of markers of epithelial proliferation compared between the two arms
Change in expression of markers of stromal proliferation and growth factors compared between the two arms
Change in expression of progesterone receptor and progesterone-regulated pathway genes compared between the two arms
Month 24
Change in mammographic breast density between the two arms as measured by volumetric percent density

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Teriparatide
30%Contusion
15%Arthralgia
12%Nausea
12%Fatigue
12%Headache
9%Cough
9%Bronchitis
9%Pain in extremity
6%Hypokalaemia
6%Urine abnormality
6%Local swelling
6%Dysgeusia
6%Rash
3%Chest pain
3%Nasopharyngitis
3%Abdominal discomfort
3%Constipation
3%Joint swelling
3%Muscular weakness
3%Chronic obstructive pulmonary disease
3%Oropharyngeal pain
3%Vaginal discharge
3%Post procedural discomfort
3%Swelling face
3%Lung adenocarcinoma
3%Abdominal pain lower
3%Bone pain
3%Tendon disorder
3%Joint stiffness
3%Sensation of heaviness
3%Bladder spasm
3%Basal cell carcinoma
3%Nephrolithiasis
3%Sneezing
3%Onychoclasis
3%Lymph node pain
3%Dry eye
3%Spider vein
3%Diarrhoea
3%Gastroenteritis
3%Abdominal pain
3%Gastrooesophageal reflux disease
3%Injection site erythema
3%Ear infection
3%Thirst
3%Alopecia
3%Fall
3%Loss of consciousness
3%Groin pain
3%Foot deformity
3%Hyperhidrosis
3%Pruritus
3%Tremor
3%Urticaria
3%Haematoma
3%Dizziness
3%Skin induration
3%Hypotension
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01753856) in the Teriparatide ARM group. Side effects include: Contusion with 30%, Arthralgia with 15%, Nausea with 12%, Fatigue with 12%, Headache with 12%.

Trial Design

2 Treatment Groups

Denosumab
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

210 Total Participants · 2 Treatment Groups

Primary Treatment: Denosumab · Has Placebo Group · Phase 2

DenosumabExperimental Group · 5 Interventions: Blood draw, Core needle biopsy, Calcium, Denosumab, Vitamin D3 · Intervention Types: Procedure, Procedure, Drug, Drug, Drug
PlaceboPlaceboComparator Group · 5 Interventions: Blood draw, Core needle biopsy, Calcium, Placebo, Vitamin D3 · Intervention Types: Procedure, Procedure, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood draw
2019
Completed Phase 4
~6340
Calcium
Not yet FDA approved
Denosumab
FDA approved
Cholecalciferol
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from 12 months to 24 months

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,442 Previous Clinical Trials
24,578,068 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,805 Previous Clinical Trials
2,278,405 Total Patients Enrolled
Adetunji T Toriola, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine

Eligibility Criteria

Age 18+ · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Breast density is higher than the threshold for the given category.
You are at least 40 years old.
You are able to understand and willing to sign an IRB-approved written informed consent document.