EUCTR2020-005974-91-EE进行中（未招募）1 期
A Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
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
- •Each patient must meet all of the following criteria to be randomized in this study:
- •1. Women, 50 to 80 years of age, both inclusive.
- •2. Body weight between 40.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
- •3. Postmenopausal, as defined by:
- •a) No menstrual period for at least 12 consecutive months prior to the Screening visit with follicle-stimulating hormone (FSH) level = 30 mIU/mL assessed by central laboratory at Screening visit, or
- •b) Surgical menopause (bilateral oophorectomy with or without hysterectomy) = 12 months prior to the Screening visit
- •4. Bone mineral density T-score = - 2.5 and = - 4.0 at the lumbar spine (L1 to L4) as assessed by the central imaging vendor based on DXA scan at Screening.
- •5. Patient must have at least 3 vertebrae considered evaluable at the lumbar spine (L1 to L4) and at least 1 hip considered evaluable by DXA scan assessed by the central imaging vendor at Screening. Patient with unilateral metal in hips that would be allowed for the other side of 1 evaluable hip is included.
- •6. Patient with albumin-adjusted total serum calcium = 8.5 mg/dL (= 2.125 mmol/L) at Screening.
- •7. Patient has adequate hepatic function at Screening as defined by the following clinical chemistry results:
- •a) Aspartate aminotransferase and alanine aminotransferase = 3 × upper limit of normal (ULN)
- •b) Alkaline phosphatase = 2 × ULN and total bilirubin = 2 × ULN
- •8. In good general health as determined by medical history, physical examination, and laboratory tests and able to walk without assistance, at the Investigator’s discretion.
- •9. Patient and/or their legally authorized representative must be informed and given ample time and opportunity to read and/or understand the nature and purpose of this study including possible risks, side effects and requirements for supplementation, and must sign the informed consent form (ICF) before any study specific procedures.
- •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 132
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 308
排除标准
- •1.Patient who has previously received denosumab (Prolia, Xgeva, or biosimilar denosumab) any other monoclonal antibodies (e.g. romosozumab),or biologic agents for osteoporosis 2.Patient with hypersensitivity to any component of denosumab or dry natural rubber (a derivative of latex) 3.Patient who is confirmed or suspected with infection of COVID-19 at Screening or has contact with COVID-19 patient within 14 days from Screening.
- •4.Patient who currently has, or has history of, any of the following inf. a) Known inf. with active hepatitis B,C,or HIV. Patient with past hepatitis B virus allowed if resolved (b)Any severe/active inf. or history of inf. requiring hospitalization, parenteral antibiotics (Ab)within 4weeks prior to first study drug adm or oral Ab within 2 weeks prior to first study drug adm. 5. Patient who has a med. history of and/or current disease incl.:(a)One severe or>2 moderate vertebral fractures (severe fracture is defined as >40% vertebral height loss and moderate fracture is defined as 25% to 40% vertebral height loss as determined by central reading of lateral spine X-ray; (b)Hip fracture;(c)Hyperparathyroidism or hypoparathyroidism;(d)(e) Current hyperthyroidism /Current hypothyroidism (unless both well controlled);(f)Bone disease and metabolic disease(except for osteoporosis) that may interfere with the interpretation of the results including osteomalacia, osteogenesis imperfecta, Paget's disease,rheumatoid arthritis, ankylosing spondylitis,osteopetrosis, fibrous dysplasia, an elevation of ALP at the PI's discretion, Cushing's disease, hyperprolactinemia, malabsorption syndrome, advanced scoliosis or extensive lumbar fusion; (g)History of severe skeletal pain with bisphosphonates; (h)History and/or current oral or dental conditions including osteomyelitis or osteonecrosis of the jaw; active dental or jaw condition which requires oral surgery; planned invasive dental procedure (e.g., tooth extr., dental implants, oral surgery); unhealed dental oral surgery; (i) History of any malignancy within 5 years prior to first study drug adm except adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ. Any history of bone metastases, implant radiation involving the skeleton, or skeletal malignancies are exclusionary; (J) New York Heart Association (NYHA) Class III or IV chronic heart failure,unstable cardiovascular disease, pulmonary disease, autoimmune disease or electrocardiogram (ECG) abnormalities which can be judged as clinically significant at PI's discretion 6. Patient has one of the following laboratory test result at Screening (a) Serum 25-OH vitamin D < 20 ng/mL (if vitamin D deficiency has been supplemented at PI’s discretion, and retest result shows the level above 20 ng/mL within Screening period, the patient can be enrolled in the study. The retest is limited up to twice within the Screening period); b) Estimated glomerular filtration rate <30 mL/min/1.73 m2; c) Hemoglobin <10 g/dL 7. Patient who has a history of and/or concurrent use of medications incl. any of the following:
- •(a)Receipt of i.v bisphosphonates, fluoride, and strontium for osteoporosis within the last 5 years prior to first adm of study drug; (b)Receipt of oral bisphosphonates =3 yrs cumulatively prior to Screening or receipt of any dose of oral bisphosphonates within 12months prior to Screening;(c)Use of parathyroid hormone (PTH) or its derivatives, systemic hormone-replacement therapy, (estrogen with or wit
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