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Senolytic
Senolytics for Improving Skeletal Health in Older Adults
Phase 2
Waitlist Available
Led By Sundeep Khosla, MD
Research Sponsored by Sundeep Khosla, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal postmenopausal women aged ≥60 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4, 8, 12, 16, 20 weeks
Awards & highlights
Study Summary
This trial is testing whether a senolytic drug can help reduce senescent cells and improve bone health markers in elderly women.
Who is the study for?
This trial is for postmenopausal women aged 60 or older who are in good health and can consent to participate. They shouldn't have type II diabetes on insulin, recent fractures, allergies to Dasatinib/Quercetin, certain blood disorders, liver/kidney disease, active cancer, heart issues or be taking drugs that affect bone turnover or prolong QTc.Check my eligibility
What is being tested?
The study tests if senolytic drugs (Dasatinib, Quercetin, Fisetin) can decrease aging cells and improve markers of bone health in elderly women. It aims to see whether these drugs help reduce bone loss and increase bone formation.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the medications tested (Dasatinib/Quercetin), changes in blood sugar levels or liver enzymes which will be monitored closely. If any abnormal lab results occur treatment will stop and a retest will happen after a month.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 60 or older and have gone through menopause.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4, 8, 12, 16, 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4, 8, 12, 16, 20 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Changes in C-terminal telopeptide of type I collagen [CTX]
Secondary outcome measures
BMD changes
Percent changes in bone turnover markers
Plasma SASP factors
Side effects data
From 2022 Phase 2 trial • 54 Patients • NCT0302304626%
Febrile neutropenia
17%
Sepsis
9%
Mucositis oral
4%
Upper gastrointestinal hemorrhage
4%
Intracranial hemorrhage
4%
Hypotension
4%
Hypertension
4%
Enterocolitis
2%
Lower gastrointestinal hemorrhage
2%
Delirium
2%
Oropharyngeal pain
2%
Gastric hemorrhage
2%
Abdominal pain
2%
Diarrhea
2%
Fungemia
2%
Typhlitis
2%
Myocardial infarction
2%
Fibrinogen decreased
2%
Endophthalmitis
2%
Multi-organ failure
2%
Kidney infection
2%
Peripheral motor neuropathy
2%
Hypoxia
2%
Sinus bradycardia
2%
Edema limbs
2%
Small intestinal obstruction
2%
Atrial fibrillation
2%
Aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Fisetin Treatment GroupExperimental Treatment1 Intervention
Subjects will receive Fisetin (F; ~20 mg/kg/day for three consecutive days) taken orally on an intermittent schedule (starting every 28 days) with no-therapy periods in between dosing regimens, repeated every 28 days over 20 weeks, resulting in five total dosing periods throughout the entire intervention
Group II: Dasatinib plus Quercetin Treatment GoupExperimental Treatment2 Interventions
Subjects will receive Dasatinib (D; 100 mg for two days) plus Quercetin (Q; 1000 mg total daily for three consecutive days taken orally on an intermittent schedule (starting every 28 days) with no-therapy periods in between dosing regimens, repeated every 28 days over 20 weeks, resulting in five total dosing periods throughout the entire intervention
Group III: Untreated Control GroupActive Control1 Intervention
Subjects will not receive any intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
FDA approved
Quercetin
Not yet FDA approved
Fisetin
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Sundeep Khosla, M.D.Lead Sponsor
1 Previous Clinical Trials
420 Total Patients Enrolled
Sundeep Khosla, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital-Rochester Saint Marys Campus, Mayo Clinic Rochester
Harvard Medical Sch (Medical School)
Mass Gen Hospital (Residency)
6 Previous Clinical Trials
766 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a type II diabetic and I take insulin.I have been diagnosed with Cushing's syndrome.I am a woman aged 60 or older and have gone through menopause.I have had a gastric bypass or stomach reduction surgery.I have an active cancer diagnosis.I have been diagnosed with acromegaly.I have an overactive thyroid.I have been diagnosed with hypopituitarism.I have had a fracture in the last 6 months.I am unable to give consent by myself.I am on medication that affects bone health.I am on medication that can affect my heart's rhythm.I am currently taking antibiotics.I am taking medication to prevent blood clots.I am currently taking medication for stomach acid.I am experiencing swelling due to fluid retention.I have a history of high blood pressure in the lungs.I am currently taking quinolone antibiotics.I have been diagnosed with heart failure.I am taking medication to prevent blood clots.I am currently diagnosed with or being treated for malabsorption.My liver or kidney function is significantly impaired.I am on medication that reacts to certain enzymes.I have or am being treated for abnormal parathyroid hormone levels.I am on a medication that targets cancer growth.I am not taking any medication that targets aging cells.I am currently taking medication for stomach acid.I cannot take medicine by mouth.My PBTL p16INK4a mRNA levels are not higher than 95% of young female controls.
Research Study Groups:
This trial has the following groups:- Group 1: Dasatinib plus Quercetin Treatment Goup
- Group 2: Fisetin Treatment Group
- Group 3: Untreated Control Group
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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 perilous implications to employing Dasatinib for health purposes?
"Dasatinib's safety profile was rated a 2, as the Phase 2 trial has produced evidence of security but not yet demonstrated efficacy."
Answered by AI
How many participants are actively engaged in this clinical experiment?
"Affirmative, clinicaltrials.gov attests to the fact that this research trial is currently enrolling patients. The initial posting of this experiment was on June 9th 2020 and its most recent update occurred on July 22nd 2022. For successful completion, a total of 120 volunteers need to be recruited from 1 designated site."
Answered by AI
Are there any precedential investigations involving Dasatinib?
"At this time, there are 72 active clinical trials for the medication Dasatinib: 9 of these studies have reached phase 3. Most locations running tests with Dasatinib are situated in New york; however, additional 4266 medical facilities across the world are conducting similar research."
Answered by AI
Are slots available within this clinical trial for participants?
"Affirmative. Clinicaltrials.gov data suggests that this medical trial, which was posted on June 9th 2020, is actively recruiting patients. The goal is to recruit 120 participants from one location."
Answered by AI
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