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
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
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
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.
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Conditions
Cancer Related
Treatments