2022-502076-23-00招募中2 期
Senolytics to Improve Osteoporosis therapy: A randomised controlled clinical trial The SENIOR Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in circulating marker of bone resorption (CTX) at 21 weeks.
研究概览
简要总结
to investigate the efficacy and safety of dasatinib plus quercetin or nicotinamide riboside on bone resorption in patients with low bone mass
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Men and women (menopause > 5 years and FSH and LH in the postmenopausal range) aged 60-90 years
- •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) (FRAX ranging from 7-70), or 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
排除标准
- •DXA of hip or spine not possible e.g., due to a prosthesis
- •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.
- •The study will exclude subjects with inability to speak and understand Danish and with inability to cooperate.
- •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)
- •QTc >470 msec
- •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.
- •Inability to take oral medication
- •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.
结局指标
主要结局
Change in circulating marker of bone resorption (CTX) at 21 weeks.
Change in circulating marker of bone resorption (CTX) at 21 weeks.
次要结局
- Bone resorption marker tartrate resistant acid phosphatase (TRAcP) at 21 weeks.
- Bone formation markers (PINP, osteocalcin, and bone alkaline phosphatase) at 21 weeks.
研究者
KMEB lab
Scientific
Odense University Hospital
研究点 (1)
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