Osteopenia, OsteoporosisPhase 2SENIORNCT06018467
Senolytics to Improve Osteoporosis Therapy
A Phase 2 study testing Dasatinib 100 Mg Oral Tablet, Quercetin 1.250 mg (oral) and Nicotinamide Riboside 1g (oral) in people with Osteopenia, Osteoporosis and Age-related Bone Loss, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Osteopenia, Osteoporosis, Age-related Bone Loss
- What is being tested?
- Dasatinib 100 Mg Oral Tablet, Quercetin 1.250 mg (oral) and Nicotinamide Riboside 1g (oral)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Sep 2023to 24 Apr 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 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)
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SENolytics to Improve Osteoporosis Therapy: a Randomised Controlled Clinical Trial The SENIOR Trial
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.
Read the detailed description
Background, hypothesis, and aim:
Evidence suggests that it is feasible to alleviate chronic age-related disorders by targeting the biology of aging. Recent studies implicate cellular senescence at the nexus of skeletal aging, suggesting that selectively eliminating senescent cells may emerge as a conceptually novel approach to manage the enormous problem of age-related bone loss. In addition, previous studies have demonstrated that antioxidants inhibit cellular senescence. The aim of this randomised clinical trial is to study osteoporosis as a disease of accelerated skeletal aging caused by accumulation of senescent cells within the skeleton and investigate the effects and safety of senolytics and antioxidant therapy on bone.
The main trial endpoint is the percent change in circulating marker of bone resorption (CTX) measured at baseline and at week 21. Secondary endpoints are the changes in bone resorption marker tartrate resistant acid phosphatase (TRAcP) and bone formation markers (PINP, osteocalcin, and bone alkaline phosphatase) measured at baseline and at 21 weeks.
Trial design:
The study design is a randomised controlled open-label clinical trial. Study participants will be randomised 1:1:1 to one of three treatment groups, that will include either,
- a combination of 100 mg/d dasatinib (oral) for two consecutive days and 1.250 mg/d quercetin (oral) for three consecutive days followed by 25 days without treatment, with treatment being repeated every 4 weeks for a total of 20 weeks (i.e., 5 times), or
- treatment with 1 g nicotinamide riboside (NR) (oral) daily for 20 weeks, or
- no treatment for 20 weeks.
Each participant will have a total of 7 to 10 visits at the clinical site. Blood samples will be obtained at all but one visit (2x20 ml each time). ECG will be performed at 4-6 visits for group 1 and at 2 visits for group 2 and 3. Scans will be performed at the first two and the last visit. Muscle-function tests will be performed at 2nd and last visit. Bone biopsies for RNA-sequencing (a technique indicating which of the genes encoded in our DNA that are active) will be collected in those that provide a separate consent and in up to 20 participants in each group (using block randomisation to ensure balanced distribution of sex and age, equaling a maximum of 60 biopsies.
- Conditions
- Osteopenia, Osteoporosis, Age-related Bone Loss
- Being tested
- Dasatinib 100 Mg Oral Tablet, Quercetin 1.250 mg (oral), Nicotinamide Riboside 1g (oral)
- Keywords
- Age related bone loss, Cellular senescence, senolytic, senolytics, Dasatinib, Quercetin, NR, Nicoinamide riboside
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dasatinib 100 Mg Oral TabletDrug
Also called Sprycel
Dasatinib tablets in blister packs of 10 tablets, from either: "Sandoz", "STADA Nordic", "Zentiva" or "Bristol-Myers Squibb"
Quercetin 1.250 mg (oral)Dietary supplement
Also called Quercetin Phytosome
five 200mg Quercetin Phytosome capsules, from Thorne
Nicotinamide Riboside 1g (oral)Dietary supplement
Also called NR
four 250mg Nicotinamide Riboside Capsules, from Elysium Health
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib plus Quercetin (DQ) | Experimental | Study participants will receive a combination of 100 mg/d dasatinib (oral) for two consecutive days and 1.250 mg/d quercetin (oral) for three consecutive days followed by 25 days without treatment, with treatment being repeated every 4 weeks for a total of 20 weeks (i.e., 5 times) Receives: Drug: Dasatinib 100 Mg Oral Tablet; Dietary Supplement: Quercetin 1.250 mg (oral) |
| Nicotinamide Riboside (NR) | Experimental | The participants will receive treatment with 1g Nicotinamide Riboside (oral) daily for 20 weeks Receives: Dietary Supplement: Nicotinamide Riboside 1g (oral) |
| Control | No intervention | The participants in the Control group, will not receive any treatment for 20 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone resorption marker CTX
Change in circulating marker of bone resorption C-terminal telopeptide of type I collagen (CTX) at 21 weeks.
Measured: Baseline, week 5, week 13, week 21
Secondary outcomes (2)
Bone resorption marker TRAcP
Change in circulating marker of bone resorption Tartrate Resistant Acid Phosphatase (TRAcP) at 21 weeks.
Measured: Baseline, week 5, week 13, week 21
Bone formation markers (PINP, osteocalcin, and bone alkaline phosphatase)
Change in circulating markers of bone formation (PINP, osteocalcin, and bone alkaline phosphatase) at 21 weeks.
Measured: Baseline, week 5, week 13, week 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start6 Sep 2023
- Primary completion24 Apr 2026
- Study completion24 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopenia, OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense Patient Data Explorative Network, The Novo Nordisk Foundation Center for Basic Metabolic Research
- Responsible party
- Sponsor
- Investigators
- Moustapha Kassem, DMSc, PhD, Principal investigator, Head of Research, Department of Endocrinology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018467
- Sponsor's protocol ID
- EU CT: 2022-502076-23-00
- Other IDs
- 2022-502076-23-00, NNF21OC0067839
- Acronym
- SENIOR
- Status last verified
- Oct 2026
- First submitted
- 23 Aug 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After completion of the project and irrespective of the outcomes, de-identified trial results will be published in peer-reviewed journals and www.clinicaltrials.gov. A summary of the clinical trial results will be presented in a language understandable to the layperson and made available in the EU database.