EUCTR2021-004811-26-BG招募中1 期
A Phase 3, Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia®in Postmenopausal Women with Osteoporosis - DANUBE
Alkem Laboratories Limited0 个研究点目标入组 504 人开始时间: 2022年3月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 504
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1.Postmenopausal women aged = 55 and = 85 years
- •2.Body weight = 50 kg and = 90 kg
- •3.Diagnosed with osteoporosis, with absolute BMD consistent with T-scores of = -2.5 and = - 4.0 at the lumbar spine (L1-L4 region) as measured by dual-energy X ray absorptiometry (DXA) at screening
- •4.At least 5 years of postmenopausal status confirmed by follicle-stimulating hormone (FSH) levels at screening
- •5.At least one hip joint and two vertebrae in L1-L4 region evaluable by DXA
- •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 126
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 378
排除标准
- •1.Previous exposure to Prolia® or any other denosumab biosimilar
- •2.Previous use of oral bisphosphonates:
- •a.Used for 3 or more years cumulatively
- •b.If used for < 3 years, use within the past 12 months prior to screening
- •3.Use of intravenous bisphosphonates within the past 5 years prior to screening
- •4.Use of parathyroid hormone or its derivatives, systemic hormone replacement therapy, selective estrogen-receptor modulators, or tibolone or calcitonin within 12 months prior to enrollment
- •5.Any prior use of fluoride or strontium
- •6.Systemic glucocorticoids (= 5 mg prednisone equivalent per day or cumulative dose = 50 mg) for more than 10 days within 3 months prior to enrollment
- •7.Other bone active drugs (i.e. drugs affecting bone metabolism) including heparin, anti epileptics (except for benzodiazepines and pregabalin), antidepressants such as SSRIs, SNRIs, antipsychotics, systemic ketoconazole, ACTH, lithium, protease inhibitors, GnRH agonists, or anabolic steroids within the past 3 months prior to screening or requiring treatment with these agents during the study
- •8.History of one severe or more than two moderate vertebral fractures per Genant classification as determined by the central reading center
- •9.History of hip fracture or bilateral hip replacement
- •10.Total hip or femoral neck T-score <-4.0
- •11.History and/or presence of atypical femoral fracture
- •12.Presence of any active healing fracture according to the Investigator’s assessment
- •13.History of any transplant or chronic immunosuppression
- •14.Severe liver dysfunction ([ALT] or [AST] > 3 times upper limit of normal)
- •15.Positive testing for hepatitis B ([HbsAg]) or hepatitis C ([HCV Ab]) virology
- •16.Known history of human immunodeficiency virus (HIV) infection or positive serology for HIV at screening
- •17.Significantly impaired renal function (determined by glomerular filtration rate of < 45 mL/min/1.73 m2 by the Modification of Diet in Renal Disease (MDRD) formula, as calculated by the central laboratory) or receiving dialysis
- •18.Oral or dental conditions:
- •a.Osteomyelitis or history and/or presence of osteonecrosis of the jaw (ONJ)
- •b.Presence of risk factors for ONJ
- •c.Active dental or jaw condition which requires oral surgery
- •d.Planned invasive dental procedure
- •19.Clinically significant leukopenia, neutropenia, or anemia as determined by the Investigator or any other clinically significant medical condition or laboratory abnormality that, in the opinion of the Investigator, would pose a risk to patient safety or interfere with adherence to study procedures, study completion, or the interpretation of study results
- •20.Patient with an active infection or history of infection as follows:
- •a.Any active infection for which systemic anti-infectives were used within 4 weeks prior to randomization
- •b.A serious infection defined as requiring hospitalization or intravenous anti infectives within 8 weeks prior to randomization
- •c.Recurrent or chronic infections or other active infection that, in the opinion of the Investigator, might compromise the safety of the patient
- •21.Evidence of any of the following conditions per laboratory test results, medical history, electrocardiogram (ECG), DXA, or X-ray review:
- •a.Uncontrolled hyperthyroidism or hypothyroidism
- •b.History or current hyperparathyroidism or hypoparathyroidism (intact parathyroid hormone levels not within normal range)
- •c.Vitamin D deficiency defined as 25 (OH) vitamin D level < 20 ng/mL (< 50 nmol/L)
- •d.Current hypocalcemia (albumin-adjusted s
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