Your session is about to expire
← Back to Search
Monoclonal Antibodies
RANKL Inhibition for Dense Breasts (TRIDENT Trial)
Phase 2
Recruiting
Led By Adetunji T Toriola, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 40 years of age.
Female.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 12 months to 24 months
Awards & highlights
TRIDENT Trial 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.
Who is the study for?
This trial is for premenopausal women at least 40 years old with dense breasts, as shown on a mammogram. Participants must be able to consent and not have a history of certain breast conditions or cancer, known BRCA mutations, or be using related medications. They should not be pregnant or planning pregnancy during the trial.Check my eligibility
What is being tested?
The study tests if RANKL inhibition with denosumab can reduce mammographic density in high-risk women with dense breasts. It also examines its effect on proliferation markers and breast cancer risk biomarkers. The trial includes blood draws, biopsies, and supplements like calcium and vitamin D3.See study design
What are the potential side effects?
Potential side effects may include issues related to bone health such as osteonecrosis of the jaw, infection risks due to immune system changes from denosumab, and common drug-related reactions like fatigue or skin rash.
TRIDENT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
Select...
I am female.
TRIDENT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 12 months to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 12 months to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in mammographic breast density between the two arms as measured by volumetric percent density
Other outcome measures
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
+4 moreSide effects data
From 2022 Phase 4 trial • 37 Patients • NCT0402625644%
joint pain
22%
nausea
22%
propagation of fracture at biopsy site
11%
dizziness
11%
rhinorrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Denosumab Only
Teriparatide Only
Denosumab and Teriparatide
TRIDENT Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DenosumabExperimental Treatment5 Interventions
Subcutaneous injection of denosumab at a dose of 60 mg at two time points: baseline and 6 months
Participants will also be instructed to take calcium and vitamin D supplements daily for 12 months between baseline examination and 12-month mammographic breast density examination.
Mammographic breast density will be assessed at three time points in all participants: baseline, 12 months, and 24 months. A 36-month optional assessment may also occur.
Biopsies and blood draws will occur for research purposes at baseline and 12 months.
Group II: PlaceboPlacebo Group5 Interventions
Subcutaneous injection of the placebo at a dose of 60 mg at two time points: baseline and 6 months
Participants will also be instructed to take calcium and vitamin D supplements daily for 12 months between baseline examination and 12 month mammographic breast density examination
Mammographic breast density will be assessed at three time points in all participants: baseline, 12 months, and 24 months. A 36 month optional assessment may also occur.
Biopsies and blood draws will occur for research purposes at baseline and 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood draw
2021
Completed Phase 4
~6290
Calcium
2014
Completed Phase 4
~4660
Denosumab
2017
Completed Phase 4
~12500
Vitamin D3
2011
Completed Phase 4
~3590
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,666 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,545 Total Patients Enrolled
Adetunji T Toriola, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of breast cancer or another type of cancer, except for non-melanoma skin cancer.I am 40 years old or older.I have been diagnosed with osteoporosis or severe osteopenia.I have ongoing dental issues or upcoming oral surgery.I am premenopausal or have not gone through menopause.I have had a tooth pulled, dental implant, or oral surgery recently.I am currently taking tamoxifen, aromatase inhibitors, bisphosphonates, or RANKL inhibitors.I have had bone disease in my jaw.I have a known BRCA mutation.I am female.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Denosumab
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any patients who have not yet been recruited for this research?
"The clinical trial is recruiting participants. According to information found on clinicaltrials.gov, the trial was posted on 8/27/2019 and most recently edited on 3/30/2022."
Answered by AI
Are there any significant dangers associated with Denosumab?
"While Phase 2 trials provide some evidence of a medication's safety, there is no data yet supporting efficacy. Therefore, our team has given Denosumab a score of 2."
Answered by AI
For what purpose is Denosumab most often given to patients?
"Denosumab is not only effective in treating nutritional supplementation, but also has shown efficacy when managing other medical conditions such as rheumatoid arthritis, spinal cord compression, and calcium absorption."
Answered by AI
How many willing test subjects are being allowed to participate in this experiment?
"That is correct. The clinical trial website has the most recent information which shows that the study was last updated on 3/30/2022 and is still actively looking for 210 patients at 1 location."
Answered by AI
Denosumab has been researched before, correct?
"As of now, 135 clinical trials are being conducted to research Denosumab with 46 of those in Phase 3. Most investigations for Denosumab are taking place in Miami, Florida; however, there are a total 8,110 locations worldwide where studies related to Denosumab are occurring."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger