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Active, not recruiting Phase 2

Senolytics to Improve Osteoporosis Therapy

NCT06018467 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 2
Started
2023-09-06
Last updated
2026-05-11

Condition(s) studied

Osteopenia, OsteoporosisAge-related Bone Loss

Investigational drug(s) / intervention(s)

Dasatinib 100 Mg Oral Tablet →Quercetin 1.250 mg (oral)Nicotinamide Riboside 1g (oral)

Dasatinib 100 Mg Oral Tablet: Dasatinib tablets in blister packs of 10 tablets, from either: "Sandoz", "STADA Nordic", "Zentiva" or "Bristol-Myers Squibb"

Quercetin 1.250 mg (oral): five 200mg Quercetin Phytosome capsules, from Thorne

Nicotinamide Riboside 1g (oral): four 250mg Nicotinamide Riboside Capsules, from Elysium Health

Study summary

This randomised clinical trial aims to study osteoporosis as a disease of accelerated skeletal aging caused by the accumulation of senescent cells within the skeleton and investigate the effects and safety of senolytics and antioxidant therapy on bone.

Eligibility

Sex
ALL
Min age
60 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * Men and women (menopause \> 5 years and FSH and LH in the postmenopausal range) aged 60-90 years with increased fracture risk according to WHO 10 years absolute Fracture Risk Assessment Tool (FRAX) 1. Osteopenia (ICD10 DM858A) based on a T-score ≤ -1 to -2.5 at the total hip/femoral neck, or lumbar spine, with or without a fragility fracture at any time (excluding hip and vertebral fractures within the last 2 years) 2. osteoporosis (ICD10 DM819) based on a T-score between ≥-3 and ≤ -2.5, which includes candidates suitable for conventional osteoporosis therapies, but who prefer to participate in the trial, despite being candidates for conventional osteoporosis therapy, or candidates which cannot be treated with conventional therapies due to contraindications * Ability to provide informed consent Exclusion Criteria: * DXA of hip or spine not possible e.g., due to a prosthesis * Inability to provide fasting blood samples * Primary hyperparathyroidism * Vitamin D deficiency (\<50 nM) (re-test after substitution acceptable) * Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, chronic kidney disease defined as eGFR \<30 or liver dysfunction, rheumatism, celiac disease/malabsorption, hypogonadism, severe COPD, hypopituitarism, Cushing's disease, uncontrolled diabetes (HbA1c \> 58 mmol/mol). * Antiresorptive or bone anabolic drugs for the last 2 years (5 years if treated with zoledronic acid) * Concomitant treatments known to influence bone metabolism e.g., glucocorticoids (systemic treatments), anabolic steroids, etc. * Subjects taking the following other drugs if they cannot be held for at least 2 days before and during administration of D+Q: digoxin, lithium, all statins, repaglidine, bosentan, gemfibrozil, olmesartan, enalapril, valsartan, methotrexate, corticosteroids, eluxadoline, eltrombopag, nitroglycerin, pioglitazone, glyburide, enzalutamide, ezetimibe, colchicine, imatinib, cyclosporine, tacrolimus, sirolimus, carbamazepine, flecainide, phenytoin, phenobarbital, rifampicin, theophylline, warfarin, heparin, clopidogrel, celecoxib, desipramine, thioridazine, venlafaxine, tizanidine, atomoxetine, voriconazole, citalopram, diazepam, escitalopram, propranolol, clozapine, cyclobenzaprine, mexiletine, olanzapine, ondansetron * Subjects taking medications that are sensitive to substrates or substrates with a narrow therapeutic range for CYP3A4, CYP2C8, CYP2C9, or CYP2D6 or strong inhibitors or inducers of CYP3A4 (e.g., cyclosporine, tacrolimus or sirolimus). If antifungals are necessary from an infectious disease perspective, then they will be allowed only if the levels are therapeutic. * Subjects taking proton pump inhibitors and unwilling to discontinue therapy for two days before and during the study drug dosing periods. * Anti-arrhythmic medications known to cause QTc prolongation * Tyrosine kinase inhibitor therapy * Subjects with an abnormal Complete Blood Count (clinically insignificant changes would be acceptable based on the judgement of the investigators) * Subjects on antiplatelet agents (Clopidogrel; Dipyridamole + ASA; ASA, Ticagrelor; Prasugrel; Ticlopidine or other) who are unable or unwilling to reduce or hold therapy prior to and during the study drug dosing periods and collection of bone biopsies. Subjects may continue their previous regimen between study drug dosing periods. * Known allergy to dasatinib, quercetin, or nicotinamide riboside * Subjects taking the following antimicrobial agents: Aminoglycosides, Azole antifungals (fluconazole, miconazole, voriconazole, itraconazole), Macrolides (clarithromycin, erythromycin), antivirals (nelfinavir, indinavir, saquinavir, ritonavir, elbasvir/grazoprevir) * Presence of any condition the Investigator believes would place the subject at risk or would preclude the subject from successfully completing all aspects of the trial e.g., heart failure, malignancy etc. * QTc \>470 msec * Inability to take oral medication * The study will exclude subjects with inability to speak and understand Danish and with inability to cooperate * BMI ≥ 40

Primary outcome measure(s)

  • Bone resorption marker CTX — Baseline, week 5, week 13, week 21
    Change in circulating marker of bone resorption C-terminal telopeptide of type I collagen (CTX) at 21 weeks.

Trial sites (1)

FacilityCityRegionStatus
Odense University Hospital Odense Denmark
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06018467 on ClinicalTrials.gov ↗ ← All trials in Denmark