EUCTR2021-005071-40-CZ进行中（未招募）1 期
A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women with Osteoporosis, ALVOBOND - ALVOBOND
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 532
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Postmenopausal women with osteoporosis willing to sign an informed consent form and able to undergo protocol related procedures.
- •2.Age: =50 years.
- •3.Female subject is postmenopausal according to 1 of the following criteria:
- •a.Spontaneous amenorrhea for =12 consecutive months
- •b.Biochemical criteria of menopause, follicle-stimulating hormone, >40 IU/L except surgically sterile
- •c.Having had bilateral oophorectomy =6 weeks prior to Screening
- •4.Body Mass Index: 18.5-32.0 kg/m2
- •5.A baseline dual-energy x-ray absorptiometry scan with a T-score =-2.5 and = -4.0 at the lumbar spine (LS) (L1 to L4) and/or total hip and/or femoral neck.
- •A subject must have a T score within the stated range of = -2.5 and = -4.0 in at least 1 of the 3 areas: - Lumbar spine (L1 to L4) - Total hip - Femoral neck. On the contrary, subjects will be excluded from the trial if the T score is less than -4.0 in at least 1 of the 3 areas (ie, at the LS [L1 to L4], or total hip, or femoral neck).
- •Note: The left hip should be scanned for the calculation of total hip T score. If the left hip cannot be scanned (eg, due to left hip replacement, etc), the right hip can be scanned instead. The same hip should be used for all dual-energy x-ray absorptiometry scans.
- •6.At least 2 consecutive evaluable lumbar vertebrae and at least 1 evaluable hip.
- •7.Willing to receive calcium plus vitamin D supplements.
- •8.No history or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the Investigator, would pose a risk to subject safety.
- •9.Resting supine systolic blood pressure of =150 mmHg and diastolic blood pressure of =90 mmHg. Other vital signs showing no clinically relevant deviations according to the Investigator’s judgment.
- •10.12-lead electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Investigator.
- •11.Subject smokes <10 cigarettes per day within 3 months of Screening. Note: It is strongly recommended that subjects do not smoke during their participation in the study.
- •12.Recommended to abstain from alcohol from 48 hours prior to study drug administration, and 24 hours prior to study visits.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 76
排除标准
- •1.Evidence of clinically relevant pathology, especially prior diagnosis of bone disease, or any uncontrolled condition that will affect bone metabolism such as, but not limited to: osteogenesis imperfecta, hyperparathyroidism, non-controlled hyperthyroidism (thyroid stimulating hormone(TSH)<0.5mIU/L), non controlled hypothyroidism(TSH=5.0mIU/L), osteomalacia, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, current flare-up of osteoarthritis and/or gout, active malignancy, renal disease (defined as creatinine clearance<50mL/min as calculated by Cockcroft-Gault formula), Paget's disease of the bone, recent bone fracture(within 6 months), and malabsorption syndrome
- •2.History and/or presence of 1 severe or more than 1 moderate vertebral fractures confirmed by x-ray(according to Genant semiquantitative method).
- •3.History of hip fracture
- •4.Presence of active healing fractures
- •5.Previous treatment with denosumab and use of the following medications:
- •a.Intravenous bisphosphonates, fluoride, or strontium ranelate at any dose within 5 years prior to Screening(Scr)
- •b.Oral bisphosphonates used for>3 years cumulative use, and any dose within 12 months of Scr
- •c.Parathyroid hormone or PTH derivatives(eg, teriparatide, abaloparatide), and selective estrogen receptor modulators(eg, raloxifene) within 1year of Scr
- •d.Romozosumab within 30days prior to Scr
- •e.Calcitonin within 6months of Scr
- •f.Other bone metabolism drugs: administration of any of the following treatments within the last 3 months,
- •i.anabolic steroids or testosterone
- •ii.glucocorticoids(>5mg/day prednisone or equivalent for>10days)
- •iii.systemic hormone replacement therapy
- •iv.tibolone
- •v.calcitriol
- •vi.anticonvulsants(except benzodiazepines and pregabalin)
- •vii.heparin
- •viii.systemic use of ketoconazole, androgens, adrenocorticotropic hormone, cinacalcet or any cathepsin K inhib.(eg, odanacatib), aluminium, lithium, protease inhib., methotrexate, gonadotropin releasing hormone agonists
- •6.Osteonecrosis of the jaw or risk factors for ONJ such as invasive dental procedures(eg, tooth extraction, dental implants, oral surgery in the past 6months), periodontal, and/or pre-existing dental disease
- •7.Evidence of hypo/hypercalcemia at Scr defined as <8.6 or >10. mg/dL
- •Note: If hypocalcaemia can be excluded based on calcium, corrected calcium, albumin, PTH, vitamin D3 values but ionized calcium is pending, the subject may be randomized, as per PI assessment and confirmation that exclusion criterion 7 has not been met. This needs to be recorded on source documents
- •8.Known vitamin D deficiency (25-hydroxy vitamin D level <20ng/mL[50nmol/L]) after supplementation at Screening
- •9.Known intolerance to Ca or vitamin D
- •10.Any current active infections, including localized infections, or any recent history(within 1 week prior to study drug administration) of active infections or a history of recurrent or chronic infections
- •11.Presence of known current infection with hepatitis B or presence of positive serology – ie, hepatitis B surface antigen(HBsAg) and/or hepatitis B core antibody(anti HBc)(hepatitis B core antigen test can be performed to conclude patient status), hepatitis C virus(HCV) antibody or human immunodeficiency virus(HIV) at Scr
- •Note: Any subject with positive anti-HBc at Scr should be reviewed and evaluated by the PI to exclude active infection. It is at the PI’s discretion whether to extend diagnostics to exclude current infection of hepatitis B. A local HBV quantitative DNA
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