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
Study Details
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).
Protocol Summary
Binding Anti-denosumab Antibodies at Month 6
Timeframe: 6 months
Binding Anti-denosumab Antibodies at Month 12
Timeframe: 12 months
Neutralizing Antibodies Against Denosumab at Month 12
Timeframe: Month 12
Sodium Change From Baseline at Month 1
Timeframe: Baseline, month 1
Sodium Change From Baseline at Month 6
Timeframe: Baseline, month 6
Sodium Change From Baseline at Month 12
Timeframe: Baseline, Month 12
Potassium Change From Baseline at Month 1
Timeframe: Baseline, month 1
Potassium Change From Baseline at Month 6
Timeframe: Baseline, month 6
Potassium Change From Baseline at Month 12
Timeframe: Baseline, month 12
Chloride Change From Baseline at Month 1
Timeframe: Baseline, month 1
Chloride Change From Baseline at Month 6
Timeframe: Baseline, month 6
Chloride Change From Baseline at Month 12
Timeframe: Baseline, month 12
Bicarbonate Change From Baseline at Month 1
Timeframe: Baseline, month 1
Bicarbonate Change From Baseline at Month 6
Timeframe: Baseline, month 6
Bicarbonate Change From Baseline at Month 12
Timeframe: Baseline, month 12
Magnesium Change From Baseline at Month 1
Timeframe: Baseline, month 1
Magnesium Change From Baseline at Month 6
Timeframe: Baseline, month 6
Magnesium Change From Baseline at Month 12
Timeframe: Baseline, month 12
Blood Urea Nitrogen Change From Baseline at Month 1
Timeframe: Baseline, month 1
Blood Urea Nitrogen Change From Baseline at Month 6
Timeframe: Baseline, month 6
Blood Urea Nitrogen Change From Baseline at Month 12
Timeframe: Baseline, month 12
Creatinine Change From Baseline at Month 1
Timeframe: Baseline, month 1
Creatinine Change From Baseline at Month 6
Timeframe: Baseline, month 6
Creatinine Change From Baseline at Month 12
Timeframe: Baseline, month 12
Aspartate Amino Transferase Change From Baseline at Month 1
Timeframe: Baseline, month 1
Aspartate Amino Transferase Change From Baseline at Month 6
Timeframe: Baseline, month 6
Aspartate Amino Transferase Change From Baseline at Month 12
Timeframe: Baseline, month 12
Alanine Amino Transferase Change From Baseline at Month 1
Timeframe: Baseline, month 1
Alanine Amino Transferase Change From Baseline at Month 6
Timeframe: Baseline, month 6
Alanine Amino Transferase Change From Baseline at Month 12
Timeframe: Baseline, month 12
Total Bilirubin Change From Baseline at Month 1
Timeframe: Baseline, month 1
Total Bilirubin Change From Baseline at Month 6
Timeframe: Baseline, month 6
Total Bilirubin Change From Baseline at Month 12
Timeframe: Baseline, month 12
Albumin Change From Baseline at Month 1
Timeframe: Baseline, month 1
Albumin Change From Baseline at Month 6
Timeframe: Baseline, month 6
Albumin Change From Baseline at Month 12
Timeframe: Baseline, month 12
Total Protein Change From Baseline at Month 1
Timeframe: Baseline, month 1
Total Protein Change From Baseline at Month 6
Timeframe: Baseline, month 6
Total Protein Change From Baseline at Month 12
Timeframe: Baseline, month 12
Glucose Change From Baseline at Month 1
Timeframe: Baseline, month 1
Glucose Change From Baseline at Month 6
Timeframe: Baseline, month 6
Glucose Change From Baseline at Month 12
Timeframe: Baseline, month 12
Red Blood Cells Change From Baseline at Month 1
Timeframe: Baseline, month 1
Red Blood Cells Change From Baseline at Month 6
Timeframe: Baseline, month 6
Red Blood Cells Change From Baseline at Month 12
Timeframe: Baseline, month 12
Hemoglobin Change From Baseline at Month 1
Timeframe: Baseline, month 1
Hemoglobin Change From Baseline at Month 6
Timeframe: Baseline, month 6
Hemoglobin Change From Baseline at Month 12
Timeframe: Baseline, month 12
Reticulocytes Change From Baseline at Month 1
Timeframe: Baseline, month 1
Reticulocytes Change From Baseline at Month 6
Timeframe: Baseline, month 6
Reticulocytes Change From Baseline at Month 12
Timeframe: Baseline, month 12
Platelets Change From Baseline at Month 1
Timeframe: Baseline, month 1
Platelets Change From Baseline at Month 6
Timeframe: Baseline, month 6
Platelets Change From Baseline at Month 12
Timeframe: Baseline, month 12
White Blood Cells Change From Baseline at Month 1
Timeframe: Baseline, month 1
White Blood Cells Change From Baseline at Month 6
Timeframe: Baseline, month 6
White Blood Cells Change From Baseline at Month 12
Timeframe: Baseline, month 12
Total Neutrophils Change From Baseline at Month 1
Timeframe: Baseline, month 1
Total Neutrophils Change From Baseline at Month 6
Timeframe: Baseline, month 6
Total Neutrophils Change From Baseline at Month 12
Timeframe: Baseline, month 12
Eosinophils Change From Baseline at Month 1
Timeframe: Baseline, month 1
Eosinophils Change From Baseline at Month 6
Timeframe: Baseline, month 6
Eosinophils Change From Baseline at Month 12
Timeframe: Baseline, month 12
Basophils Change From Baseline at Month 1
Timeframe: Baseline, month 1
Basophils Change From Baseline at Month 6
Timeframe: Baseline, month 6
Basophils Change From Baseline at Month 12
Timeframe: Baseline, month 12
Lymphocytes Change From Baseline at Month 1
Timeframe: Baseline, month 1
Lymphocytes Change From Baseline at Month 6
Timeframe: Baseline, month 6
Lymphocytes Change From Baseline at Month 12
Timeframe: Baseline, month 12
Monocytes Change From Baseline at Month 1
Timeframe: Baseline, month 1
Monocytes Change From Baseline at Month 6
Timeframe: Baseline, month 6
Monocytes Change From Baseline at Month 12
Timeframe: Baseline, month 12
Subject Incidence of Laboratory CTCAE grade greater or equal to 3
Timeframe: month 1, month 6, month 12