CTRI/2023/11/059935招募中3 期
A Prospective, Randomized, Double Blind, Multicentric, Parallel Group Phase-III Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity, Pharmacokinetics and Pharmacodynamics of BP16 Denosumab (60 mg/1ml single use Pre-filled Syringe) in Comparison to EU approved Prolia® (Denosumab, 60 mg/1ml single use Pre-filled Syringe) in Women with Postmenopausal Osteoporosis - NI
CuraTeQ Biologics Private Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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
入选标准
- •1.Ambulatory female patients of age 50 to 80 years (both inclusive).
- •2.Post menopausal female patients with at least one year since the last menstruation.
- •3.Bone Mineral Density: The subject having a BMD absolute value consistent with a T-score between -2.5 to -4.0 at either the lumbar spine or total hip.
- •4.Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
排除标准
- •1.History of any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings, Paget’s disease, Cushing’s disease or Hyperprolactinemia.
- •2.Current hyperparathyroidism or hypoparathyroidism
- •3.History of uncontrolled Hyper- or hypothyroidism except subjects on stable thyroid hormone replacement therapy.
- •4.History of Rheumatoid arthritis
- •5.History of malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5-years.
- •6.History of Cirrhosis of the liver or Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
- •7.History of Drug or alcohol abuse: Evidence of alcohol or substance-abuse within the last 12-months which the Investigator believes would interfere with understanding or completing the study.
- •8.Any physical or psychiatric disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures.
- •9.Known to have tested positive for human immunodeficiency virus (HIV), HCV, HBsAg.
- •10.Patients with Vitamin D deficiency: (25-(OH) vitamin D level < 20 ng/mL). Vitamin D repletion will be done and subjects will be re-screened with 25-(OH) vitamin D after 3 months.
- •11.Any of the following Oral/Dental Conditions
- •i.Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw.
- •ii.Active dental or jaw condition which requires oral surgery.
- •iii.Planned invasive dental procedure.
- •iv.Non-healed dental or oral surgery.
- •12.Administration of intravenous (IV) bisphosphonates anytime in the past, fluoride or strontium for osteoporosis within the last 3-years.
- •13.Patients who have undergone Oral bisphosphonates treatment in past shall be:
- •i.ineligible if Oral bisphosphonates have been used for 3 years or more cumulatively.
- •ii.if used for less than 3 years, a gap of at least one year since last dose administered is required.
- •14.Administration of any of the following treatments within the last 6-weeks:
- •i.Parathyroid hormone (PTH) or PTH derivatives, e.g., teriparatide.
- •ii.Anabolic steroids or testosterone.
- •iii.Gluco-corticosteroids (5 mg prednisone equivalent per day for more than 10 days).
- •iv.Selective estrogen receptor modulators (SERMs), e.g., raloxifene
- •vi.Calcitonin
- •vii.Other bone active drugs including anti-convulsant (except benzodiazepines) and heparin.
- •viii.Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists.
- •15.Currently enrolled in or has not yet completed at least 30-days since ending other investigational device or drug trial(s), or subject is receiving other investiga
研究者
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