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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
311
Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6
An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.
Time frame: 6 months
Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12
An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.
Time frame: 12 months
Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12
Samples demonstrating reactivity for binding antibodies to denosumab were to be tested for neutralizing or inhibitory effects in a cell-based bioassay.
Time frame: Month 12
Sodium Change From Baseline at Month 1
Laboratory chemistry sodium
Time frame: Baseline, month 1
Sodium Change From Baseline at Month 6
Laboratory chemistry sodium
Time frame: Baseline, month 6
Sodium Change From Baseline at Month 12
Sodium Change From Baseline at Month 12
Time frame: Baseline, Month 12
Potassium Change From Baseline at Month 1
Laboratory chemistry potassium
Time frame: Baseline, month 1
Potassium Change From Baseline at Month 6
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Laboratory chemistry potassium
Time frame: Baseline, month 6
Potassium Change From Baseline at Month 12
Laboratory chemistry potassium
Time frame: Baseline, month 12
Chloride Change From Baseline at Month 1
Laboratory chemistry chloride
Time frame: Baseline, month 1
Chloride Change From Baseline at Month 6
Laboratory chemistry chloride
Time frame: Baseline, month 6
Chloride Change From Baseline at Month 12
Laboratory chemistry chloride
Time frame: Baseline, month 12
Bicarbonate Change From Baseline at Month 1
Laboratory chemistry bicarbonate
Time frame: Baseline, month 1
Bicarbonate Change From Baseline at Month 6
Laboratory chemistry bicarbonate
Time frame: Baseline, month 6
Bicarbonate Change From Baseline at Month 12
Laboratory chemistry bicarbonate
Time frame: Baseline, month 12
Magnesium Change From Baseline at Month 1
Laboratory chemistry magnesium
Time frame: Baseline, month 1
Magnesium Change From Baseline at Month 6
Laboratory chemistry magnesium
Time frame: Baseline, month 6
Magnesium Change From Baseline at Month 12
Laboratory chemistry magnesium
Time frame: Baseline, month 12
Blood Urea Nitrogen Change From Baseline at Month 1
Laboratory chemistry blood urea nitrogen
Time frame: Baseline, month 1
Blood Urea Nitrogen Change From Baseline at Month 6
Laboratory chemistry blood urea nitrogen
Time frame: Baseline, month 6
Blood Urea Nitrogen Change From Baseline at Month 12
Laboratory chemistry blood urea nitrogen
Time frame: Baseline, month 12
Creatinine Change From Baseline at Month 1
Laboratory chemistry creatinine
Time frame: Baseline, month 1
Creatinine Change From Baseline at Month 6
Laboratory chemistry creatinine
Time frame: Baseline, month 6
Creatinine Change From Baseline at Month 12
Laboratory chemistry creatinine
Time frame: Baseline, month 12
Aspartate Amino Transferase Change From Baseline at Month 1
Laboratory chemistry aspartate amino transferase
Time frame: Baseline, month 1
Aspartate Amino Transferase Change From Baseline at Month 6
Laboratory chemistry aspartate amino transferase
Time frame: Baseline, month 6
Aspartate Amino Transferase Change From Baseline at Month 12
Laboratory chemistry aspartate amino transferase
Time frame: Baseline, month 12
Alanine Amino Transferase Change From Baseline at Month 1
Laboratory chemistry alanine amino transferase
Time frame: Baseline, month 1
Alanine Amino Transferase Change From Baseline at Month 6
Laboratory chemistry alanine amino transferase
Time frame: Baseline, month 6
Alanine Amino Transferase Change From Baseline at Month 12
Laboratory chemistry alanine amino transferase
Time frame: Baseline, month 12
Total Bilirubin Change From Baseline at Month 1
Laboratory chemistry total bilirubin
Time frame: Baseline, month 1
Total Bilirubin Change From Baseline at Month 6
Laboratory chemistry total bilirubin
Time frame: Baseline, month 6
Total Bilirubin Change From Baseline at Month 12
Laboratory chemistry total bilirubin
Time frame: Baseline, month 12
Albumin Change From Baseline at Month 1
Laboratory chemistry albumin
Time frame: Baseline, month 1
Albumin Change From Baseline at Month 6
Laboratory chemistry albumin
Time frame: Baseline, month 6
Albumin Change From Baseline at Month 12
Laboratory chemistry albumin
Time frame: Baseline, month 12
Total Protein Change From Baseline at Month 1
Laboratory chemistry total protein
Time frame: Baseline, month 1
Total Protein Change From Baseline at Month 6
Laboratory chemistry total protein
Time frame: Baseline, month 6
Total Protein Change From Baseline at Month 12
Laboratory chemistry total protein
Time frame: Baseline, month 12
Glucose Change From Baseline at Month 1
Laboratory chemistry glucose
Time frame: Baseline, month 1
Glucose Change From Baseline at Month 6
Laboratory chemistry glucose
Time frame: Baseline, month 6
Glucose Change From Baseline at Month 12
Laboratory chemistry glucose
Time frame: Baseline, month 12
Red Blood Cells Change From Baseline at Month 1
Laboratory hematology red blood cells
Time frame: Baseline, month 1
Red Blood Cells Change From Baseline at Month 6
Laboratory hematology red blood cells
Time frame: Baseline, month 6
Red Blood Cells Change From Baseline at Month 12
Laboratory hematology red blood cells
Time frame: Baseline, month 12
Hemoglobin Change From Baseline at Month 1
Laboratory hematology hemoglobin
Time frame: Baseline, month 1
Hemoglobin Change From Baseline at Month 6
Laboratory hematology hemoglobin
Time frame: Baseline, month 6
Hemoglobin Change From Baseline at Month 12
Laboratory hematology hemoglobin
Time frame: Baseline, month 12
Reticulocytes Change From Baseline at Month 1
Laboratory hematology reticulocytes
Time frame: Baseline, month 1
Reticulocytes Change From Baseline at Month 6
Laboratory hematology reticulocytes
Time frame: Baseline, month 6
Reticulocytes Change From Baseline at Month 12
Laboratory hematology reticulocytes
Time frame: Baseline, month 12
Platelets Change From Baseline at Month 1
Laboratory hematology platelets
Time frame: Baseline, month 1
Platelets Change From Baseline at Month 6
Laboratory hematology platelets
Time frame: Baseline, month 6
Platelets Change From Baseline at Month 12
Laboratory hematology platelets
Time frame: Baseline, month 12
White Blood Cells Change From Baseline at Month 1
Laboratory hematology white blood cells
Time frame: Baseline, month 1
White Blood Cells Change From Baseline at Month 6
Laboratory hematology white blood cells
Time frame: Baseline, month 6
White Blood Cells Change From Baseline at Month 12
Laboratory hematology white blood cells
Time frame: Baseline, month 12
Total Neutrophils Change From Baseline at Month 1
Laboratory hematology total neutrophils
Time frame: Baseline, month 1
Total Neutrophils Change From Baseline at Month 6
Laboratory hematology total neutrophils
Time frame: Baseline, month 6
Total Neutrophils Change From Baseline at Month 12
Laboratory hematology total neutrophils
Time frame: Baseline, month 12
Eosinophils Change From Baseline at Month 1
Laboratory hematology eosinophils
Time frame: Baseline, month 1
Eosinophils Change From Baseline at Month 6
Laboratory hematology eosinophils
Time frame: Baseline, month 6
Eosinophils Change From Baseline at Month 12
Laboratory hematology eosinophils
Time frame: Baseline, month 12
Basophils Change From Baseline at Month 1
Laboratory hematology basophils
Time frame: Baseline, month 1
Basophils Change From Baseline at Month 6
Laboratory hematology basophils
Time frame: Baseline, month 6
Basophils Change From Baseline at Month 12
Laboratory hematology basophils
Time frame: Baseline, month 12
Lymphocytes Change From Baseline at Month 1
Laboratory hematology lymphocytes
Time frame: Baseline, month 1
Lymphocytes Change From Baseline at Month 6
Laboratory hematology lymphocytes
Time frame: Baseline, month 6
Lymphocytes Change From Baseline at Month 12
Laboratory hematology lymphocytes
Time frame: Baseline, month 12
Monocytes Change From Baseline at Month 1
Laboratory hematology monocytes
Time frame: Baseline, month 1
Monocytes Change From Baseline at Month 6
Laboratory hematology monocytes
Time frame: Baseline, month 6
Monocytes Change From Baseline at Month 12
Laboratory hematology monocytes
Time frame: Baseline, month 12
Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3
Participants with laboratory toxicity grade 3 (severe) or 4 (life-threatening), based on the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Time frame: Day 1 to Month 12