NCT00515463已完成3 期
A Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects With Low Bone Mineral Density
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 311
- 主要终点
- Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6
研究概览
简要总结
The purpose of this study is to compare the immunogenicity profiles of denosumab pre-filled syringe (PFS) and vial at 6 months in postmenopausal women with low bone mineral density (BMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who have successfully completed the 20050141 study (NCT00330460):
- •Must have received all SC investigational product administrations in 20050141
- •Must not have taken any proscribed therapies in 20050141
- •Subjects who were in the alendronate or denosumab treatment group are allowed
- •Provide signed informed consent before any study-specific procedures are conducted
排除标准
- •Any disorder that, in the opinion of the investigator, may compromise the ability of the patient to give written informed consent and/or comply with study procedures including:
- •Any physical or psychiatric disorder
- •Or evidence of alcohol or substance abuse in the last 12 months
- •Any clinical evidence, in the medical judgement of the investigator, of the following medical conditions:
- •Impaired thyroid function (subsequent to treatment)
- •Impaired hepatic function
- •Impaired renal function
- •Rheumatoid Arthritis, Paget's disease, Cushing's disease, hyperprolactinemia, or cirrhosis of the liver
- •Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen
- •Any metabolic bone disease, eg, osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings
结局指标
主要结局
Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6
时间窗: 6 months
An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.
次要结局
- Creatinine Change From Baseline at Month 1(Baseline, month 1)
- Creatinine Change From Baseline at Month 12(Baseline, month 12)
- Aspartate Amino Transferase Change From Baseline at Month 6(Baseline, month 6)
- Total Bilirubin Change From Baseline at Month 6(Baseline, month 6)
- Albumin Change From Baseline at Month 6(Baseline, month 6)
- Total Protein Change From Baseline at Month 1(Baseline, month 1)
- Total Protein Change From Baseline at Month 6(Baseline, month 6)
- Glucose Change From Baseline at Month 12(Baseline, month 12)
- Hemoglobin Change From Baseline at Month 12(Baseline, month 12)
- Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12(Month 12)
- Sodium Change From Baseline at Month 12(Baseline, Month 12)
- Bicarbonate Change From Baseline at Month 12(Baseline, month 12)
- Magnesium Change From Baseline at Month 1(Baseline, month 1)
- Magnesium Change From Baseline at Month 6(Baseline, month 6)
- Magnesium Change From Baseline at Month 12(Baseline, month 12)
- Potassium Change From Baseline at Month 1(Baseline, month 1)
- Blood Urea Nitrogen Change From Baseline at Month 12(Baseline, month 12)
- Potassium Change From Baseline at Month 6(Baseline, month 6)
- Chloride Change From Baseline at Month 6(Baseline, month 6)
- Bicarbonate Change From Baseline at Month 6(Baseline, month 6)
- Blood Urea Nitrogen Change From Baseline at Month 6(Baseline, month 6)
- Aspartate Amino Transferase Change From Baseline at Month 12(Baseline, month 12)
- Reticulocytes Change From Baseline at Month 12(Baseline, month 12)
- Platelets Change From Baseline at Month 1(Baseline, month 1)
- Platelets Change From Baseline at Month 6(Baseline, month 6)
- Platelets Change From Baseline at Month 12(Baseline, month 12)
- White Blood Cells Change From Baseline at Month 1(Baseline, month 1)
- White Blood Cells Change From Baseline at Month 6(Baseline, month 6)
- White Blood Cells Change From Baseline at Month 12(Baseline, month 12)
- Total Neutrophils Change From Baseline at Month 1(Baseline, month 1)
- Total Neutrophils Change From Baseline at Month 6(Baseline, month 6)
- Total Neutrophils Change From Baseline at Month 12(Baseline, month 12)
- Eosinophils Change From Baseline at Month 1(Baseline, month 1)
- Eosinophils Change From Baseline at Month 6(Baseline, month 6)
- Eosinophils Change From Baseline at Month 12(Baseline, month 12)
- Basophils Change From Baseline at Month 1(Baseline, month 1)
- Basophils Change From Baseline at Month 6(Baseline, month 6)
- Basophils Change From Baseline at Month 12(Baseline, month 12)
- Lymphocytes Change From Baseline at Month 1(Baseline, month 1)
- Lymphocytes Change From Baseline at Month 6(Baseline, month 6)
- Lymphocytes Change From Baseline at Month 12(Baseline, month 12)
- Monocytes Change From Baseline at Month 1(Baseline, month 1)
- Monocytes Change From Baseline at Month 6(Baseline, month 6)
- Monocytes Change From Baseline at Month 12(Baseline, month 12)
- Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3(Day 1 to Month 12)
- Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12(12 months)
- Sodium Change From Baseline at Month 1(Baseline, month 1)
- Sodium Change From Baseline at Month 6(Baseline, month 6)
- Potassium Change From Baseline at Month 12(Baseline, month 12)
- Chloride Change From Baseline at Month 1(Baseline, month 1)
- Chloride Change From Baseline at Month 12(Baseline, month 12)
- Bicarbonate Change From Baseline at Month 1(Baseline, month 1)
- Aspartate Amino Transferase Change From Baseline at Month 1(Baseline, month 1)
- Total Bilirubin Change From Baseline at Month 12(Baseline, month 12)
- Albumin Change From Baseline at Month 1(Baseline, month 1)
- Blood Urea Nitrogen Change From Baseline at Month 1(Baseline, month 1)
- Creatinine Change From Baseline at Month 6(Baseline, month 6)
- Alanine Amino Transferase Change From Baseline at Month 1(Baseline, month 1)
- Alanine Amino Transferase Change From Baseline at Month 6(Baseline, month 6)
- Alanine Amino Transferase Change From Baseline at Month 12(Baseline, month 12)
- Glucose Change From Baseline at Month 6(Baseline, month 6)
- Red Blood Cells Change From Baseline at Month 1(Baseline, month 1)
- Red Blood Cells Change From Baseline at Month 6(Baseline, month 6)
- Total Bilirubin Change From Baseline at Month 1(Baseline, month 1)
- Albumin Change From Baseline at Month 12(Baseline, month 12)
- Total Protein Change From Baseline at Month 12(Baseline, month 12)
- Glucose Change From Baseline at Month 1(Baseline, month 1)
- Red Blood Cells Change From Baseline at Month 12(Baseline, month 12)
- Hemoglobin Change From Baseline at Month 1(Baseline, month 1)
- Hemoglobin Change From Baseline at Month 6(Baseline, month 6)
- Reticulocytes Change From Baseline at Month 1(Baseline, month 1)
- Reticulocytes Change From Baseline at Month 6(Baseline, month 6)
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