Low Bone Mineral Density, Osteopenia, Osteoporosis
Conditions
Keywords
Osteopenia, Osteoporosis, AMG 162, Postmenopausal, Pre-filled syringe
Brief summary
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).
Interventions
BIOLOGICALdenosumab
60 mg denosumab in 1mL
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6 | 6 months | An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Potassium Change From Baseline at Month 6 | Baseline, month 6 | Laboratory chemistry potassium |
| Potassium Change From Baseline at Month 12 | Baseline, month 12 | Laboratory chemistry potassium |
| Chloride Change From Baseline at Month 1 | Baseline, month 1 | Laboratory chemistry chloride |
| Chloride Change From Baseline at Month 6 | Baseline, month 6 | Laboratory chemistry chloride |
| Sodium Change From Baseline at Month 6 | Baseline, month 6 | Laboratory chemistry sodium |
| Sodium Change From Baseline at Month 12 | Baseline, Month 12 | Sodium Change From Baseline at Month 12 |
| Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12 | 12 months | An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab. |
| Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12 | Month 12 | Samples demonstrating reactivity for binding antibodies to denosumab were to be tested for neutralizing or inhibitory effects in a cell-based bioassay. |
| Sodium Change From Baseline at Month 1 | Baseline, month 1 | Laboratory chemistry sodium |
| Chloride Change From Baseline at Month 12 | Baseline, month 12 | Laboratory chemistry chloride |
| Bicarbonate Change From Baseline at Month 1 | Baseline, month 1 | Laboratory chemistry bicarbonate |
| Bicarbonate Change From Baseline at Month 6 | Baseline, month 6 | Laboratory chemistry bicarbonate |
| Bicarbonate Change From Baseline at Month 12 | Baseline, month 12 | Laboratory chemistry bicarbonate |
| Magnesium Change From Baseline at Month 1 | Baseline, month 1 | Laboratory chemistry magnesium |
| Magnesium Change From Baseline at Month 6 | Baseline, month 6 | Laboratory chemistry magnesium |
| Magnesium Change From Baseline at Month 12 | Baseline, month 12 | Laboratory chemistry magnesium |
| Blood Urea Nitrogen Change From Baseline at Month 1 | Baseline, month 1 | Laboratory chemistry blood urea nitrogen |
| Blood Urea Nitrogen Change From Baseline at Month 6 | Baseline, month 6 | Laboratory chemistry blood urea nitrogen |
| Blood Urea Nitrogen Change From Baseline at Month 12 | Baseline, month 12 | Laboratory chemistry blood urea nitrogen |
| Creatinine Change From Baseline at Month 1 | Baseline, month 1 | Laboratory chemistry creatinine |
| Creatinine Change From Baseline at Month 6 | Baseline, month 6 | Laboratory chemistry creatinine |
| Creatinine Change From Baseline at Month 12 | Baseline, month 12 | Laboratory chemistry creatinine |
| Aspartate Amino Transferase Change From Baseline at Month 1 | Baseline, month 1 | Laboratory chemistry aspartate amino transferase |
| Aspartate Amino Transferase Change From Baseline at Month 6 | Baseline, month 6 | Laboratory chemistry aspartate amino transferase |
| Aspartate Amino Transferase Change From Baseline at Month 12 | Baseline, month 12 | Laboratory chemistry aspartate amino transferase |
| Alanine Amino Transferase Change From Baseline at Month 1 | Baseline, month 1 | Laboratory chemistry alanine amino transferase |
| Alanine Amino Transferase Change From Baseline at Month 6 | Baseline, month 6 | Laboratory chemistry alanine amino transferase |
| Alanine Amino Transferase Change From Baseline at Month 12 | Baseline, month 12 | Laboratory chemistry alanine amino transferase |
| Total Bilirubin Change From Baseline at Month 1 | Baseline, month 1 | Laboratory chemistry total bilirubin |
| Total Bilirubin Change From Baseline at Month 6 | Baseline, month 6 | Laboratory chemistry total bilirubin |
| Total Bilirubin Change From Baseline at Month 12 | Baseline, month 12 | Laboratory chemistry total bilirubin |
| Albumin Change From Baseline at Month 1 | Baseline, month 1 | Laboratory chemistry albumin |
| Albumin Change From Baseline at Month 6 | Baseline, month 6 | Laboratory chemistry albumin |
| Albumin Change From Baseline at Month 12 | Baseline, month 12 | Laboratory chemistry albumin |
| Total Protein Change From Baseline at Month 1 | Baseline, month 1 | Laboratory chemistry total protein |
| Total Protein Change From Baseline at Month 6 | Baseline, month 6 | Laboratory chemistry total protein |
| Total Protein Change From Baseline at Month 12 | Baseline, month 12 | Laboratory chemistry total protein |
| Glucose Change From Baseline at Month 1 | Baseline, month 1 | Laboratory chemistry glucose |
| Glucose Change From Baseline at Month 6 | Baseline, month 6 | Laboratory chemistry glucose |
| Glucose Change From Baseline at Month 12 | Baseline, month 12 | Laboratory chemistry glucose |
| Red Blood Cells Change From Baseline at Month 1 | Baseline, month 1 | Laboratory hematology red blood cells |
| Red Blood Cells Change From Baseline at Month 6 | Baseline, month 6 | Laboratory hematology red blood cells |
| Red Blood Cells Change From Baseline at Month 12 | Baseline, month 12 | Laboratory hematology red blood cells |
| Hemoglobin Change From Baseline at Month 1 | Baseline, month 1 | Laboratory hematology hemoglobin |
| Hemoglobin Change From Baseline at Month 6 | Baseline, month 6 | Laboratory hematology hemoglobin |
| Hemoglobin Change From Baseline at Month 12 | Baseline, month 12 | Laboratory hematology hemoglobin |
| Reticulocytes Change From Baseline at Month 1 | Baseline, month 1 | Laboratory hematology reticulocytes |
| Reticulocytes Change From Baseline at Month 6 | Baseline, month 6 | Laboratory hematology reticulocytes |
| Reticulocytes Change From Baseline at Month 12 | Baseline, month 12 | Laboratory hematology reticulocytes |
| Platelets Change From Baseline at Month 1 | Baseline, month 1 | Laboratory hematology platelets |
| Platelets Change From Baseline at Month 6 | Baseline, month 6 | Laboratory hematology platelets |
| Platelets Change From Baseline at Month 12 | Baseline, month 12 | Laboratory hematology platelets |
| White Blood Cells Change From Baseline at Month 1 | Baseline, month 1 | Laboratory hematology white blood cells |
| White Blood Cells Change From Baseline at Month 6 | Baseline, month 6 | Laboratory hematology white blood cells |
| White Blood Cells Change From Baseline at Month 12 | Baseline, month 12 | Laboratory hematology white blood cells |
| Total Neutrophils Change From Baseline at Month 1 | Baseline, month 1 | Laboratory hematology total neutrophils |
| Total Neutrophils Change From Baseline at Month 6 | Baseline, month 6 | Laboratory hematology total neutrophils |
| Total Neutrophils Change From Baseline at Month 12 | Baseline, month 12 | Laboratory hematology total neutrophils |
| Eosinophils Change From Baseline at Month 1 | Baseline, month 1 | Laboratory hematology eosinophils |
| Eosinophils Change From Baseline at Month 6 | Baseline, month 6 | Laboratory hematology eosinophils |
| Eosinophils Change From Baseline at Month 12 | Baseline, month 12 | Laboratory hematology eosinophils |
| Basophils Change From Baseline at Month 1 | Baseline, month 1 | Laboratory hematology basophils |
| Potassium Change From Baseline at Month 1 | Baseline, month 1 | Laboratory chemistry potassium |
| Basophils Change From Baseline at Month 12 | Baseline, month 12 | Laboratory hematology basophils |
| Lymphocytes Change From Baseline at Month 1 | Baseline, month 1 | Laboratory hematology lymphocytes |
| Lymphocytes Change From Baseline at Month 6 | Baseline, month 6 | Laboratory hematology lymphocytes |
| Lymphocytes Change From Baseline at Month 12 | Baseline, month 12 | Laboratory hematology lymphocytes |
| Monocytes Change From Baseline at Month 1 | Baseline, month 1 | Laboratory hematology monocytes |
| Monocytes Change From Baseline at Month 6 | Baseline, month 6 | Laboratory hematology monocytes |
| Monocytes Change From Baseline at Month 12 | Baseline, month 12 | Laboratory hematology monocytes |
| Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3 | Day 1 to Month 12 | Participants with laboratory toxicity grade 3 (severe) or 4 (life-threatening), based on the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. |
| Basophils Change From Baseline at Month 6 | Baseline, month 6 | Laboratory hematology basophils |
Participant flow
Recruitment details
Patients who successfully completed Study 20050141 (NCT00330460) were eligible to participate in this study. First Subject Enrolled: 30-May-2007 Last Subject Enrolled: 10-Sep-2007
Participants by arm
| Arm | Count |
|---|---|
| Denosumab - Vial Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6. | 155 |
| Denosumab - Pre-filled Syringe Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6. | 156 |
| Total | 311 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lost to Follow-up | 6 | 5 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Physician Decision | 4 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Denosumab - Vial | Denosumab - Pre-filled Syringe | Total |
|---|---|---|---|
| Age Continuous | 62.5 Years STANDARD_DEVIATION 8.5 | 62.9 Years STANDARD_DEVIATION 8.9 | 62.7 Years STANDARD_DEVIATION 8.7 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 24 Participants | 18 Participants | 42 Participants |
| Race/Ethnicity, Customized Japanese | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White or Caucasian | 124 Participants | 131 Participants | 255 Participants |
| Sex: Female, Male Female | 155 Participants | 156 Participants | 311 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 32 / 154 | 49 / 156 |
| serious Total, serious adverse events | 7 / 154 | 12 / 156 |
Outcome results
Primary
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
Population: Patients who received ≥ 1 dose of investigational product, have a baseline and ≥ 1 post-baseline antibody assessment and did not have binding anti-denosumab antibodies present at baseline, and with evaluable antibody results at 6 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Denosumab - Vial | Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6 | 0 Participants |
| Denosumab - Pre-filled Syringe | Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6 | 0 Participants |
95% CI: [-0.7, 0.7]
Secondary
Alanine Amino Transferase Change From Baseline at Month 1
Laboratory chemistry alanine amino transferase
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Alanine Amino Transferase Change From Baseline at Month 1 | -3.1 U/L | Standard Deviation 25.7 |
| Denosumab - Pre-filled Syringe | Alanine Amino Transferase Change From Baseline at Month 1 | 0.5 U/L | Standard Deviation 5.5 |
Secondary
Alanine Amino Transferase Change From Baseline at Month 12
Laboratory chemistry alanine amino transferase
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Alanine Amino Transferase Change From Baseline at Month 12 | -2.7 U/L | Standard Deviation 28.8 |
| Denosumab - Pre-filled Syringe | Alanine Amino Transferase Change From Baseline at Month 12 | 1.5 U/L | Standard Deviation 6.3 |
Secondary
Alanine Amino Transferase Change From Baseline at Month 6
Laboratory chemistry alanine amino transferase
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Alanine Amino Transferase Change From Baseline at Month 6 | -1.4 U/L | Standard Deviation 27.8 |
| Denosumab - Pre-filled Syringe | Alanine Amino Transferase Change From Baseline at Month 6 | 4.2 U/L | Standard Deviation 15.2 |
Secondary
Albumin Change From Baseline at Month 1
Laboratory chemistry albumin
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Albumin Change From Baseline at Month 1 | -0.46 g/L | Standard Deviation 1.68 |
| Denosumab - Pre-filled Syringe | Albumin Change From Baseline at Month 1 | -0.40 g/L | Standard Deviation 2.05 |
Secondary
Albumin Change From Baseline at Month 12
Laboratory chemistry albumin
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Albumin Change From Baseline at Month 12 | -0.26 g/L | Standard Deviation 1.82 |
| Denosumab - Pre-filled Syringe | Albumin Change From Baseline at Month 12 | 0 g/L | Standard Deviation 2.03 |
Secondary
Albumin Change From Baseline at Month 6
Laboratory chemistry albumin
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Albumin Change From Baseline at Month 6 | -0.34 g/L | Standard Deviation 1.92 |
| Denosumab - Pre-filled Syringe | Albumin Change From Baseline at Month 6 | -0.51 g/L | Standard Deviation 2.19 |
Secondary
Aspartate Amino Transferase Change From Baseline at Month 1
Laboratory chemistry aspartate amino transferase
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Aspartate Amino Transferase Change From Baseline at Month 1 | -1.6 U/L | Standard Deviation 13 |
| Denosumab - Pre-filled Syringe | Aspartate Amino Transferase Change From Baseline at Month 1 | 0.4 U/L | Standard Deviation 4.7 |
Secondary
Aspartate Amino Transferase Change From Baseline at Month 12
Laboratory chemistry aspartate amino transferase
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Aspartate Amino Transferase Change From Baseline at Month 12 | -1.9 U/L | Standard Deviation 13.5 |
| Denosumab - Pre-filled Syringe | Aspartate Amino Transferase Change From Baseline at Month 12 | 0.2 U/L | Standard Deviation 3.9 |
Secondary
Aspartate Amino Transferase Change From Baseline at Month 6
Laboratory chemistry aspartate amino transferase
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Aspartate Amino Transferase Change From Baseline at Month 6 | -1.6 U/L | Standard Deviation 13.9 |
| Denosumab - Pre-filled Syringe | Aspartate Amino Transferase Change From Baseline at Month 6 | 0.9 U/L | Standard Deviation 7.7 |
Secondary
Basophils Change From Baseline at Month 1
Laboratory hematology basophils
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Basophils Change From Baseline at Month 1 | 0.001 10^9/L | Standard Deviation 0.025 |
| Denosumab - Pre-filled Syringe | Basophils Change From Baseline at Month 1 | 0 10^9/L | Standard Deviation 0.022 |
Secondary
Basophils Change From Baseline at Month 12
Laboratory hematology basophils
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Basophils Change From Baseline at Month 12 | 0.003 10^9/L | Standard Deviation 0.026 |
| Denosumab - Pre-filled Syringe | Basophils Change From Baseline at Month 12 | 0.006 10^9/L | Standard Deviation 0.024 |
Secondary
Basophils Change From Baseline at Month 6
Laboratory hematology basophils
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Basophils Change From Baseline at Month 6 | 0.012 10^9/L | Standard Deviation 0.026 |
| Denosumab - Pre-filled Syringe | Basophils Change From Baseline at Month 6 | 0.012 10^9/L | Standard Deviation 0.028 |
Secondary
Bicarbonate Change From Baseline at Month 1
Laboratory chemistry bicarbonate
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Bicarbonate Change From Baseline at Month 1 | -0.3 mmol/L | Standard Deviation 2.9 |
| Denosumab - Pre-filled Syringe | Bicarbonate Change From Baseline at Month 1 | 0 mmol/L | Standard Deviation 2.9 |
Secondary
Bicarbonate Change From Baseline at Month 12
Laboratory chemistry bicarbonate
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Bicarbonate Change From Baseline at Month 12 | -0.6 mmol/L | Standard Deviation 2.8 |
| Denosumab - Pre-filled Syringe | Bicarbonate Change From Baseline at Month 12 | -0.1 mmol/L | Standard Deviation 2.8 |
Secondary
Bicarbonate Change From Baseline at Month 6
Laboratory chemistry bicarbonate
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Bicarbonate Change From Baseline at Month 6 | 0.2 mmol/L | Standard Deviation 2.7 |
| Denosumab - Pre-filled Syringe | Bicarbonate Change From Baseline at Month 6 | 0.1 mmol/L | Standard Deviation 2.9 |
Secondary
Blood Urea Nitrogen Change From Baseline at Month 1
Laboratory chemistry blood urea nitrogen
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Blood Urea Nitrogen Change From Baseline at Month 1 | 0.01 mmol/L | Standard Deviation 1.3 |
| Denosumab - Pre-filled Syringe | Blood Urea Nitrogen Change From Baseline at Month 1 | -0.04 mmol/L | Standard Deviation 1.38 |
Secondary
Blood Urea Nitrogen Change From Baseline at Month 12
Laboratory chemistry blood urea nitrogen
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Blood Urea Nitrogen Change From Baseline at Month 12 | 0.27 mmol/L | Standard Deviation 1.44 |
| Denosumab - Pre-filled Syringe | Blood Urea Nitrogen Change From Baseline at Month 12 | -0.02 mmol/L | Standard Deviation 1.5 |
Secondary
Blood Urea Nitrogen Change From Baseline at Month 6
Laboratory chemistry blood urea nitrogen
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Blood Urea Nitrogen Change From Baseline at Month 6 | 0.09 mmol/L | Standard Deviation 1.4 |
| Denosumab - Pre-filled Syringe | Blood Urea Nitrogen Change From Baseline at Month 6 | 0.11 mmol/L | Standard Deviation 1.49 |
Secondary
Chloride Change From Baseline at Month 1
Laboratory chemistry chloride
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Chloride Change From Baseline at Month 1 | -0.1 mmol/L | Standard Deviation 2.1 |
| Denosumab - Pre-filled Syringe | Chloride Change From Baseline at Month 1 | 0.2 mmol/L | Standard Deviation 1.9 |
Secondary
Chloride Change From Baseline at Month 12
Laboratory chemistry chloride
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Chloride Change From Baseline at Month 12 | -0.2 mmol/L | Standard Deviation 2.1 |
| Denosumab - Pre-filled Syringe | Chloride Change From Baseline at Month 12 | 0 mmol/L | Standard Deviation 2.5 |
Secondary
Chloride Change From Baseline at Month 6
Laboratory chemistry chloride
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Chloride Change From Baseline at Month 6 | -0.9 mmol/L | Standard Deviation 2.3 |
| Denosumab - Pre-filled Syringe | Chloride Change From Baseline at Month 6 | -0.4 mmol/L | Standard Deviation 2 |
Secondary
Creatinine Change From Baseline at Month 1
Laboratory chemistry creatinine
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Creatinine Change From Baseline at Month 1 | 0.24 umol/L | Standard Deviation 8.01 |
| Denosumab - Pre-filled Syringe | Creatinine Change From Baseline at Month 1 | 0.12 umol/L | Standard Deviation 7.76 |
Secondary
Creatinine Change From Baseline at Month 12
Laboratory chemistry creatinine
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Creatinine Change From Baseline at Month 12 | 1.40 umol/L | Standard Deviation 9.53 |
| Denosumab - Pre-filled Syringe | Creatinine Change From Baseline at Month 12 | 0.76 umol/L | Standard Deviation 8.28 |
Secondary
Creatinine Change From Baseline at Month 6
Laboratory chemistry creatinine
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Creatinine Change From Baseline at Month 6 | -0.19 umol/L | Standard Deviation 8.52 |
| Denosumab - Pre-filled Syringe | Creatinine Change From Baseline at Month 6 | -1.29 umol/L | Standard Deviation 8.23 |
Secondary
Eosinophils Change From Baseline at Month 1
Laboratory hematology eosinophils
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Eosinophils Change From Baseline at Month 1 | -0.002 10^9/L | Standard Deviation 0.065 |
| Denosumab - Pre-filled Syringe | Eosinophils Change From Baseline at Month 1 | -0.010 10^9/L | Standard Deviation 0.059 |
Secondary
Eosinophils Change From Baseline at Month 12
Laboratory hematology eosinophils
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Eosinophils Change From Baseline at Month 12 | -0.008 10^9/L | Standard Deviation 0.071 |
| Denosumab - Pre-filled Syringe | Eosinophils Change From Baseline at Month 12 | 0.025 10^9/L | Standard Deviation 0.436 |
Secondary
Eosinophils Change From Baseline at Month 6
Laboratory hematology eosinophils
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Eosinophils Change From Baseline at Month 6 | 0.020 10^9/L | Standard Deviation 0.075 |
| Denosumab - Pre-filled Syringe | Eosinophils Change From Baseline at Month 6 | 0.013 10^9/L | Standard Deviation 0.104 |
Secondary
Glucose Change From Baseline at Month 1
Laboratory chemistry glucose
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Glucose Change From Baseline at Month 1 | -0.08 mmol/L | Standard Deviation 1.27 |
| Denosumab - Pre-filled Syringe | Glucose Change From Baseline at Month 1 | 0.03 mmol/L | Standard Deviation 0.69 |
Secondary
Glucose Change From Baseline at Month 12
Laboratory chemistry glucose
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Glucose Change From Baseline at Month 12 | -0.06 mmol/L | Standard Deviation 1.27 |
| Denosumab - Pre-filled Syringe | Glucose Change From Baseline at Month 12 | 0.08 mmol/L | Standard Deviation 0.92 |
Secondary
Glucose Change From Baseline at Month 6
Laboratory chemistry glucose
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Glucose Change From Baseline at Month 6 | -0.08 mmol/L | Standard Deviation 1.37 |
| Denosumab - Pre-filled Syringe | Glucose Change From Baseline at Month 6 | 0.05 mmol/L | Standard Deviation 0.8 |
Secondary
Hemoglobin Change From Baseline at Month 1
Laboratory hematology hemoglobin
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Hemoglobin Change From Baseline at Month 1 | -0.97 g/L | Standard Deviation 6 |
| Denosumab - Pre-filled Syringe | Hemoglobin Change From Baseline at Month 1 | -0.42 g/L | Standard Deviation 6.24 |
Secondary
Hemoglobin Change From Baseline at Month 12
Laboratory hematology hemoglobin
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Hemoglobin Change From Baseline at Month 12 | -1.74 g/L | Standard Deviation 6.09 |
| Denosumab - Pre-filled Syringe | Hemoglobin Change From Baseline at Month 12 | -0.22 g/L | Standard Deviation 6.62 |
Secondary
Hemoglobin Change From Baseline at Month 6
Laboratory hematology hemoglobin
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Hemoglobin Change From Baseline at Month 6 | 0.84 g/L | Standard Deviation 5.83 |
| Denosumab - Pre-filled Syringe | Hemoglobin Change From Baseline at Month 6 | 0.96 g/L | Standard Deviation 6.34 |
Secondary
Lymphocytes Change From Baseline at Month 1
Laboratory hematology lymphocytes
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Lymphocytes Change From Baseline at Month 1 | 0.12 10^9/L | Standard Deviation 0.43 |
| Denosumab - Pre-filled Syringe | Lymphocytes Change From Baseline at Month 1 | 0.04 10^9/L | Standard Deviation 0.4 |
Secondary
Lymphocytes Change From Baseline at Month 12
Laboratory hematology lymphocytes
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Lymphocytes Change From Baseline at Month 12 | 0.08 10^9/L | Standard Deviation 0.41 |
| Denosumab - Pre-filled Syringe | Lymphocytes Change From Baseline at Month 12 | 0.06 10^9/L | Standard Deviation 0.36 |
Secondary
Lymphocytes Change From Baseline at Month 6
Laboratory hematology lymphocytes
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Lymphocytes Change From Baseline at Month 6 | 0.01 10^9/L | Standard Deviation 0.37 |
| Denosumab - Pre-filled Syringe | Lymphocytes Change From Baseline at Month 6 | -0.06 10^9/L | Standard Deviation 0.45 |
Secondary
Magnesium Change From Baseline at Month 1
Laboratory chemistry magnesium
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Magnesium Change From Baseline at Month 1 | 0.001 mmol/L | Standard Deviation 0.092 |
| Denosumab - Pre-filled Syringe | Magnesium Change From Baseline at Month 1 | -0.010 mmol/L | Standard Deviation 0.08 |
Secondary
Magnesium Change From Baseline at Month 12
Laboratory chemistry magnesium
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Magnesium Change From Baseline at Month 12 | -0.053 mmol/L | Standard Deviation 0.062 |
| Denosumab - Pre-filled Syringe | Magnesium Change From Baseline at Month 12 | -0.055 mmol/L | Standard Deviation 0.074 |
Secondary
Magnesium Change From Baseline at Month 6
Laboratory chemistry magnesium
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Magnesium Change From Baseline at Month 6 | -0.053 mmol/L | Standard Deviation 0.073 |
| Denosumab - Pre-filled Syringe | Magnesium Change From Baseline at Month 6 | -0.064 mmol/L | Standard Deviation 0.08 |
Secondary
Monocytes Change From Baseline at Month 1
Laboratory hematology monocytes
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Monocytes Change From Baseline at Month 1 | 0 10^9/L | Standard Deviation 0.12 |
| Denosumab - Pre-filled Syringe | Monocytes Change From Baseline at Month 1 | 0.01 10^9/L | Standard Deviation 0.11 |
Secondary
Monocytes Change From Baseline at Month 12
Laboratory hematology monocytes
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Monocytes Change From Baseline at Month 12 | 0.01 10^9/L | Standard Deviation 0.13 |
| Denosumab - Pre-filled Syringe | Monocytes Change From Baseline at Month 12 | 0.03 10^9/L | Standard Deviation 0.14 |
Secondary
Monocytes Change From Baseline at Month 6
Laboratory hematology monocytes
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Monocytes Change From Baseline at Month 6 | -0.03 10^9/L | Standard Deviation 0.14 |
| Denosumab - Pre-filled Syringe | Monocytes Change From Baseline at Month 6 | -0.03 10^9/L | Standard Deviation 0.1 |
Secondary
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
Population: Patients who received ≥ 1 dose of investigational product, have a baseline and ≥ 1 post-baseline antibody assessment and did not have binding anti-denosumab antibodies present at baseline, and with evaluable antibody results at 12 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Denosumab - Vial | Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12 | 0 Participants |
| Denosumab - Pre-filled Syringe | Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12 | 0 Participants |
95% CI: [-0.7, 0.7]
Secondary
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
Population: Patients who received ≥ 1 dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Denosumab - Vial | Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3 | Number of patients with CTCAE grade 3 or 4 | 2 Participants |
| Denosumab - Vial | Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3 | Sodium - Grade 3 below normal (< 130 - 120 mmol/L) | 0 Participants |
| Denosumab - Vial | Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3 | Potassium - Grade 3 above normal (>6.0-7.0 mmol/L) | 0 Participants |
| Denosumab - Vial | Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3 | Magnesium -Grade 3 above normal (>1.23-3.30mmol/L) | 2 Participants |
| Denosumab - Pre-filled Syringe | Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3 | Magnesium -Grade 3 above normal (>1.23-3.30mmol/L) | 0 Participants |
| Denosumab - Pre-filled Syringe | Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3 | Number of patients with CTCAE grade 3 or 4 | 2 Participants |
| Denosumab - Pre-filled Syringe | Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3 | Potassium - Grade 3 above normal (>6.0-7.0 mmol/L) | 1 Participants |
| Denosumab - Pre-filled Syringe | Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3 | Sodium - Grade 3 below normal (< 130 - 120 mmol/L) | 1 Participants |
Secondary
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
Population: Patients testing positive for binding antibodies to denosumab.
Secondary
Platelets Change From Baseline at Month 1
Laboratory hematology platelets
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Platelets Change From Baseline at Month 1 | 5.24 10^9/L | Standard Deviation 33.2 |
| Denosumab - Pre-filled Syringe | Platelets Change From Baseline at Month 1 | 2.48 10^9/L | Standard Deviation 36.2 |
Secondary
Platelets Change From Baseline at Month 12
Laboratory hematology platelets
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Platelets Change From Baseline at Month 12 | 25.19 10^9/L | Standard Deviation 42.07 |
| Denosumab - Pre-filled Syringe | Platelets Change From Baseline at Month 12 | 15.60 10^9/L | Standard Deviation 41.82 |
Secondary
Platelets Change From Baseline at Month 6
Laboratory hematology platelets
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Platelets Change From Baseline at Month 6 | 28.26 10^9/L | Standard Deviation 32.16 |
| Denosumab - Pre-filled Syringe | Platelets Change From Baseline at Month 6 | 21.49 10^9/L | Standard Deviation 53.82 |
Secondary
Potassium Change From Baseline at Month 1
Laboratory chemistry potassium
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Potassium Change From Baseline at Month 1 | 0.02 mmol/L | Standard Deviation 0.37 |
| Denosumab - Pre-filled Syringe | Potassium Change From Baseline at Month 1 | 0 mmol/L | Standard Deviation 0.39 |
Secondary
Potassium Change From Baseline at Month 12
Laboratory chemistry potassium
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Potassium Change From Baseline at Month 12 | 0.07 mmol/L | Standard Deviation 0.4 |
| Denosumab - Pre-filled Syringe | Potassium Change From Baseline at Month 12 | 0.04 mmol/L | Standard Deviation 0.4 |
Secondary
Potassium Change From Baseline at Month 6
Laboratory chemistry potassium
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Potassium Change From Baseline at Month 6 | 0.01 mmol/L | Standard Deviation 0.43 |
| Denosumab - Pre-filled Syringe | Potassium Change From Baseline at Month 6 | -0.07 mmol/L | Standard Deviation 0.4 |
Secondary
Red Blood Cells Change From Baseline at Month 1
Laboratory hematology red blood cells
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Red Blood Cells Change From Baseline at Month 1 | 0 10^12/L | Standard Deviation 0.21 |
| Denosumab - Pre-filled Syringe | Red Blood Cells Change From Baseline at Month 1 | 0.02 10^12/L | Standard Deviation 0.23 |
Secondary
Red Blood Cells Change From Baseline at Month 12
Laboratory hematology red blood cells
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Red Blood Cells Change From Baseline at Month 12 | -0.01 10^12/L | Standard Deviation 0.22 |
| Denosumab - Pre-filled Syringe | Red Blood Cells Change From Baseline at Month 12 | 0.02 10^12/L | Standard Deviation 0.23 |
Secondary
Red Blood Cells Change From Baseline at Month 6
Laboratory hematology red blood cells
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Red Blood Cells Change From Baseline at Month 6 | 0.04 10^12/L | Standard Deviation 0.22 |
| Denosumab - Pre-filled Syringe | Red Blood Cells Change From Baseline at Month 6 | 0.04 10^12/L | Standard Deviation 0.22 |
Secondary
Reticulocytes Change From Baseline at Month 1
Laboratory hematology reticulocytes
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Reticulocytes Change From Baseline at Month 1 | 3.70 10^9/L | Standard Deviation 17.68 |
| Denosumab - Pre-filled Syringe | Reticulocytes Change From Baseline at Month 1 | 1.69 10^9/L | Standard Deviation 17.41 |
Secondary
Reticulocytes Change From Baseline at Month 12
Laboratory hematology reticulocytes
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Reticulocytes Change From Baseline at Month 12 | 19.09 10^9/L | Standard Deviation 19.82 |
| Denosumab - Pre-filled Syringe | Reticulocytes Change From Baseline at Month 12 | 15.08 10^9/L | Standard Deviation 19.73 |
Secondary
Reticulocytes Change From Baseline at Month 6
Laboratory hematology reticulocytes
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Reticulocytes Change From Baseline at Month 6 | 19.54 10^9/L | Standard Deviation 19.22 |
| Denosumab - Pre-filled Syringe | Reticulocytes Change From Baseline at Month 6 | 15.21 10^9/L | Standard Deviation 20.69 |
Secondary
Sodium Change From Baseline at Month 1
Laboratory chemistry sodium
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Sodium Change From Baseline at Month 1 | -0.1 mmol/L | Standard Deviation 2 |
| Denosumab - Pre-filled Syringe | Sodium Change From Baseline at Month 1 | 0.1 mmol/L | Standard Deviation 1.7 |
Secondary
Sodium Change From Baseline at Month 12
Sodium Change From Baseline at Month 12
Time frame: Baseline, Month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Sodium Change From Baseline at Month 12 | -0.9 mmol/L | Standard Deviation 2.1 |
| Denosumab - Pre-filled Syringe | Sodium Change From Baseline at Month 12 | -0.6 mmol/L | Standard Deviation 2 |
Secondary
Sodium Change From Baseline at Month 6
Laboratory chemistry sodium
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Sodium Change From Baseline at Month 6 | -1.2 mmol/L | Standard Deviation 2 |
| Denosumab - Pre-filled Syringe | Sodium Change From Baseline at Month 6 | -0.9 mmol/L | Standard Deviation 1.8 |
Secondary
Total Bilirubin Change From Baseline at Month 1
Laboratory chemistry total bilirubin
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Total Bilirubin Change From Baseline at Month 1 | -0.35 umol/L | Standard Deviation 2.53 |
| Denosumab - Pre-filled Syringe | Total Bilirubin Change From Baseline at Month 1 | -0.02 umol/L | Standard Deviation 2.47 |
Secondary
Total Bilirubin Change From Baseline at Month 12
Laboratory chemistry total bilirubin
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Total Bilirubin Change From Baseline at Month 12 | 0.16 umol/L | Standard Deviation 2.68 |
| Denosumab - Pre-filled Syringe | Total Bilirubin Change From Baseline at Month 12 | 0.64 umol/L | Standard Deviation 2.74 |
Secondary
Total Bilirubin Change From Baseline at Month 6
Laboratory chemistry total bilirubin
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Total Bilirubin Change From Baseline at Month 6 | -0.30 umol/L | Standard Deviation 2.54 |
| Denosumab - Pre-filled Syringe | Total Bilirubin Change From Baseline at Month 6 | -0.20 umol/L | Standard Deviation 2.67 |
Secondary
Total Neutrophils Change From Baseline at Month 1
Laboratory hematology total neutrophils
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Total Neutrophils Change From Baseline at Month 1 | 0.11 10^9/L | Standard Deviation 0.85 |
| Denosumab - Pre-filled Syringe | Total Neutrophils Change From Baseline at Month 1 | -0.03 10^9/L | Standard Deviation 1.1 |
Secondary
Total Neutrophils Change From Baseline at Month 12
Laboratory hematology total neutrophils
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Total Neutrophils Change From Baseline at Month 12 | 0.38 10^9/L | Standard Deviation 1.15 |
| Denosumab - Pre-filled Syringe | Total Neutrophils Change From Baseline at Month 12 | 0.12 10^9/L | Standard Deviation 1.18 |
Secondary
Total Neutrophils Change From Baseline at Month 6
Laboratory hematology total neutrophils
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Total Neutrophils Change From Baseline at Month 6 | 0.21 10^9/L | Standard Deviation 1.23 |
| Denosumab - Pre-filled Syringe | Total Neutrophils Change From Baseline at Month 6 | -0.02 10^9/L | Standard Deviation 1.23 |
Secondary
Total Protein Change From Baseline at Month 1
Laboratory chemistry total protein
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Total Protein Change From Baseline at Month 1 | -0.59 g/L | Standard Deviation 2.67 |
| Denosumab - Pre-filled Syringe | Total Protein Change From Baseline at Month 1 | -0.54 g/L | Standard Deviation 3.45 |
Secondary
Total Protein Change From Baseline at Month 12
Laboratory chemistry total protein
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Total Protein Change From Baseline at Month 12 | -1.35 g/L | Standard Deviation 2.84 |
| Denosumab - Pre-filled Syringe | Total Protein Change From Baseline at Month 12 | -0.91 g/L | Standard Deviation 3.28 |
Secondary
Total Protein Change From Baseline at Month 6
Laboratory chemistry total protein
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | Total Protein Change From Baseline at Month 6 | -0.58 g/L | Standard Deviation 3 |
| Denosumab - Pre-filled Syringe | Total Protein Change From Baseline at Month 6 | -0.80 g/L | Standard Deviation 3.33 |
Secondary
White Blood Cells Change From Baseline at Month 1
Laboratory hematology white blood cells
Time frame: Baseline, month 1
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | White Blood Cells Change From Baseline at Month 1 | 0.23 10^9/L | Standard Deviation 1.07 |
| Denosumab - Pre-filled Syringe | White Blood Cells Change From Baseline at Month 1 | 0.01 10^9/L | Standard Deviation 1.26 |
Secondary
White Blood Cells Change From Baseline at Month 12
Laboratory hematology white blood cells
Time frame: Baseline, month 12
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | White Blood Cells Change From Baseline at Month 12 | 0.47 10^9/L | Standard Deviation 1.38 |
| Denosumab - Pre-filled Syringe | White Blood Cells Change From Baseline at Month 12 | 0.24 10^9/L | Standard Deviation 1.47 |
Secondary
White Blood Cells Change From Baseline at Month 6
Laboratory hematology white blood cells
Time frame: Baseline, month 6
Population: Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab - Vial | White Blood Cells Change From Baseline at Month 6 | 0.22 10^9/L | Standard Deviation 1.38 |
| Denosumab - Pre-filled Syringe | White Blood Cells Change From Baseline at Month 6 | -0.08 10^9/L | Standard Deviation 1.47 |