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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

Primary Purpose

Low Bone Mineral Density, Osteopenia, Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
denosumab
denosumab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Bone Mineral Density focused on measuring Osteopenia, Osteoporosis, AMG 162, Postmenopausal, Pre-filled syringe

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Denosumab - Vial

    Denosumab - Prefilled syringe

    Arm Description

    Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.

    Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    Sodium Change From Baseline at Month 1
    Laboratory chemistry sodium
    Sodium Change From Baseline at Month 6
    Laboratory chemistry sodium
    Sodium Change From Baseline at Month 12
    Sodium Change From Baseline at Month 12
    Potassium Change From Baseline at Month 1
    Laboratory chemistry potassium
    Potassium Change From Baseline at Month 6
    Laboratory chemistry potassium
    Potassium Change From Baseline at Month 12
    Laboratory chemistry potassium
    Chloride Change From Baseline at Month 1
    Laboratory chemistry chloride
    Chloride Change From Baseline at Month 6
    Laboratory chemistry chloride
    Chloride Change From Baseline at Month 12
    Laboratory chemistry chloride
    Bicarbonate Change From Baseline at Month 1
    Laboratory chemistry bicarbonate
    Bicarbonate Change From Baseline at Month 6
    Laboratory chemistry bicarbonate
    Bicarbonate Change From Baseline at Month 12
    Laboratory chemistry bicarbonate
    Magnesium Change From Baseline at Month 1
    Laboratory chemistry magnesium
    Magnesium Change From Baseline at Month 6
    Laboratory chemistry magnesium
    Magnesium Change From Baseline at Month 12
    Laboratory chemistry magnesium
    Blood Urea Nitrogen Change From Baseline at Month 1
    Laboratory chemistry blood urea nitrogen
    Blood Urea Nitrogen Change From Baseline at Month 6
    Laboratory chemistry blood urea nitrogen
    Blood Urea Nitrogen Change From Baseline at Month 12
    Laboratory chemistry blood urea nitrogen
    Creatinine Change From Baseline at Month 1
    Laboratory chemistry creatinine
    Creatinine Change From Baseline at Month 6
    Laboratory chemistry creatinine
    Creatinine Change From Baseline at Month 12
    Laboratory chemistry creatinine
    Aspartate Amino Transferase Change From Baseline at Month 1
    Laboratory chemistry aspartate amino transferase
    Aspartate Amino Transferase Change From Baseline at Month 6
    Laboratory chemistry aspartate amino transferase
    Aspartate Amino Transferase Change From Baseline at Month 12
    Laboratory chemistry aspartate amino transferase
    Alanine Amino Transferase Change From Baseline at Month 1
    Laboratory chemistry alanine amino transferase
    Alanine Amino Transferase Change From Baseline at Month 6
    Laboratory chemistry alanine amino transferase
    Alanine Amino Transferase Change From Baseline at Month 12
    Laboratory chemistry alanine amino transferase
    Total Bilirubin Change From Baseline at Month 1
    Laboratory chemistry total bilirubin
    Total Bilirubin Change From Baseline at Month 6
    Laboratory chemistry total bilirubin
    Total Bilirubin Change From Baseline at Month 12
    Laboratory chemistry total bilirubin
    Albumin Change From Baseline at Month 1
    Laboratory chemistry albumin
    Albumin Change From Baseline at Month 6
    Laboratory chemistry albumin
    Albumin Change From Baseline at Month 12
    Laboratory chemistry albumin
    Total Protein Change From Baseline at Month 1
    Laboratory chemistry total protein
    Total Protein Change From Baseline at Month 6
    Laboratory chemistry total protein
    Total Protein Change From Baseline at Month 12
    Laboratory chemistry total protein
    Glucose Change From Baseline at Month 1
    Laboratory chemistry glucose
    Glucose Change From Baseline at Month 6
    Laboratory chemistry glucose
    Glucose Change From Baseline at Month 12
    Laboratory chemistry glucose
    Red Blood Cells Change From Baseline at Month 1
    Laboratory hematology red blood cells
    Red Blood Cells Change From Baseline at Month 6
    Laboratory hematology red blood cells
    Red Blood Cells Change From Baseline at Month 12
    Laboratory hematology red blood cells
    Hemoglobin Change From Baseline at Month 1
    Laboratory hematology hemoglobin
    Hemoglobin Change From Baseline at Month 6
    Laboratory hematology hemoglobin
    Hemoglobin Change From Baseline at Month 12
    Laboratory hematology hemoglobin
    Reticulocytes Change From Baseline at Month 1
    Laboratory hematology reticulocytes
    Reticulocytes Change From Baseline at Month 6
    Laboratory hematology reticulocytes
    Reticulocytes Change From Baseline at Month 12
    Laboratory hematology reticulocytes
    Platelets Change From Baseline at Month 1
    Laboratory hematology platelets
    Platelets Change From Baseline at Month 6
    Laboratory hematology platelets
    Platelets Change From Baseline at Month 12
    Laboratory hematology platelets
    White Blood Cells Change From Baseline at Month 1
    Laboratory hematology white blood cells
    White Blood Cells Change From Baseline at Month 6
    Laboratory hematology white blood cells
    White Blood Cells Change From Baseline at Month 12
    Laboratory hematology white blood cells
    Total Neutrophils Change From Baseline at Month 1
    Laboratory hematology total neutrophils
    Total Neutrophils Change From Baseline at Month 6
    Laboratory hematology total neutrophils
    Total Neutrophils Change From Baseline at Month 12
    Laboratory hematology total neutrophils
    Eosinophils Change From Baseline at Month 1
    Laboratory hematology eosinophils
    Eosinophils Change From Baseline at Month 6
    Laboratory hematology eosinophils
    Eosinophils Change From Baseline at Month 12
    Laboratory hematology eosinophils
    Basophils Change From Baseline at Month 1
    Laboratory hematology basophils
    Basophils Change From Baseline at Month 6
    Laboratory hematology basophils
    Basophils Change From Baseline at Month 12
    Laboratory hematology basophils
    Lymphocytes Change From Baseline at Month 1
    Laboratory hematology lymphocytes
    Lymphocytes Change From Baseline at Month 6
    Laboratory hematology lymphocytes
    Lymphocytes Change From Baseline at Month 12
    Laboratory hematology lymphocytes
    Monocytes Change From Baseline at Month 1
    Laboratory hematology monocytes
    Monocytes Change From Baseline at Month 6
    Laboratory hematology monocytes
    Monocytes Change From Baseline at Month 12
    Laboratory hematology monocytes
    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.

    Full Information

    First Posted
    August 9, 2007
    Last Updated
    August 27, 2013
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00515463
    Brief Title
    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
    Official Title
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2007 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Bone Mineral Density, Osteopenia, Osteoporosis
    Keywords
    Osteopenia, Osteoporosis, AMG 162, Postmenopausal, Pre-filled syringe

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    311 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Denosumab - Vial
    Arm Type
    Experimental
    Arm Description
    Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
    Arm Title
    Denosumab - Prefilled syringe
    Arm Type
    Experimental
    Arm Description
    Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
    Intervention Type
    Biological
    Intervention Name(s)
    denosumab
    Intervention Description
    60 mg denosumab in 1mL
    Intervention Type
    Biological
    Intervention Name(s)
    denosumab
    Intervention Description
    60 mg denosumab in 1mL
    Primary Outcome Measure Information:
    Title
    Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6
    Description
    An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12
    Description
    An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.
    Time Frame
    12 months
    Title
    Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12
    Description
    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
    Title
    Sodium Change From Baseline at Month 1
    Description
    Laboratory chemistry sodium
    Time Frame
    Baseline, month 1
    Title
    Sodium Change From Baseline at Month 6
    Description
    Laboratory chemistry sodium
    Time Frame
    Baseline, month 6
    Title
    Sodium Change From Baseline at Month 12
    Description
    Sodium Change From Baseline at Month 12
    Time Frame
    Baseline, Month 12
    Title
    Potassium Change From Baseline at Month 1
    Description
    Laboratory chemistry potassium
    Time Frame
    Baseline, month 1
    Title
    Potassium Change From Baseline at Month 6
    Description
    Laboratory chemistry potassium
    Time Frame
    Baseline, month 6
    Title
    Potassium Change From Baseline at Month 12
    Description
    Laboratory chemistry potassium
    Time Frame
    Baseline, month 12
    Title
    Chloride Change From Baseline at Month 1
    Description
    Laboratory chemistry chloride
    Time Frame
    Baseline, month 1
    Title
    Chloride Change From Baseline at Month 6
    Description
    Laboratory chemistry chloride
    Time Frame
    Baseline, month 6
    Title
    Chloride Change From Baseline at Month 12
    Description
    Laboratory chemistry chloride
    Time Frame
    Baseline, month 12
    Title
    Bicarbonate Change From Baseline at Month 1
    Description
    Laboratory chemistry bicarbonate
    Time Frame
    Baseline, month 1
    Title
    Bicarbonate Change From Baseline at Month 6
    Description
    Laboratory chemistry bicarbonate
    Time Frame
    Baseline, month 6
    Title
    Bicarbonate Change From Baseline at Month 12
    Description
    Laboratory chemistry bicarbonate
    Time Frame
    Baseline, month 12
    Title
    Magnesium Change From Baseline at Month 1
    Description
    Laboratory chemistry magnesium
    Time Frame
    Baseline, month 1
    Title
    Magnesium Change From Baseline at Month 6
    Description
    Laboratory chemistry magnesium
    Time Frame
    Baseline, month 6
    Title
    Magnesium Change From Baseline at Month 12
    Description
    Laboratory chemistry magnesium
    Time Frame
    Baseline, month 12
    Title
    Blood Urea Nitrogen Change From Baseline at Month 1
    Description
    Laboratory chemistry blood urea nitrogen
    Time Frame
    Baseline, month 1
    Title
    Blood Urea Nitrogen Change From Baseline at Month 6
    Description
    Laboratory chemistry blood urea nitrogen
    Time Frame
    Baseline, month 6
    Title
    Blood Urea Nitrogen Change From Baseline at Month 12
    Description
    Laboratory chemistry blood urea nitrogen
    Time Frame
    Baseline, month 12
    Title
    Creatinine Change From Baseline at Month 1
    Description
    Laboratory chemistry creatinine
    Time Frame
    Baseline, month 1
    Title
    Creatinine Change From Baseline at Month 6
    Description
    Laboratory chemistry creatinine
    Time Frame
    Baseline, month 6
    Title
    Creatinine Change From Baseline at Month 12
    Description
    Laboratory chemistry creatinine
    Time Frame
    Baseline, month 12
    Title
    Aspartate Amino Transferase Change From Baseline at Month 1
    Description
    Laboratory chemistry aspartate amino transferase
    Time Frame
    Baseline, month 1
    Title
    Aspartate Amino Transferase Change From Baseline at Month 6
    Description
    Laboratory chemistry aspartate amino transferase
    Time Frame
    Baseline, month 6
    Title
    Aspartate Amino Transferase Change From Baseline at Month 12
    Description
    Laboratory chemistry aspartate amino transferase
    Time Frame
    Baseline, month 12
    Title
    Alanine Amino Transferase Change From Baseline at Month 1
    Description
    Laboratory chemistry alanine amino transferase
    Time Frame
    Baseline, month 1
    Title
    Alanine Amino Transferase Change From Baseline at Month 6
    Description
    Laboratory chemistry alanine amino transferase
    Time Frame
    Baseline, month 6
    Title
    Alanine Amino Transferase Change From Baseline at Month 12
    Description
    Laboratory chemistry alanine amino transferase
    Time Frame
    Baseline, month 12
    Title
    Total Bilirubin Change From Baseline at Month 1
    Description
    Laboratory chemistry total bilirubin
    Time Frame
    Baseline, month 1
    Title
    Total Bilirubin Change From Baseline at Month 6
    Description
    Laboratory chemistry total bilirubin
    Time Frame
    Baseline, month 6
    Title
    Total Bilirubin Change From Baseline at Month 12
    Description
    Laboratory chemistry total bilirubin
    Time Frame
    Baseline, month 12
    Title
    Albumin Change From Baseline at Month 1
    Description
    Laboratory chemistry albumin
    Time Frame
    Baseline, month 1
    Title
    Albumin Change From Baseline at Month 6
    Description
    Laboratory chemistry albumin
    Time Frame
    Baseline, month 6
    Title
    Albumin Change From Baseline at Month 12
    Description
    Laboratory chemistry albumin
    Time Frame
    Baseline, month 12
    Title
    Total Protein Change From Baseline at Month 1
    Description
    Laboratory chemistry total protein
    Time Frame
    Baseline, month 1
    Title
    Total Protein Change From Baseline at Month 6
    Description
    Laboratory chemistry total protein
    Time Frame
    Baseline, month 6
    Title
    Total Protein Change From Baseline at Month 12
    Description
    Laboratory chemistry total protein
    Time Frame
    Baseline, month 12
    Title
    Glucose Change From Baseline at Month 1
    Description
    Laboratory chemistry glucose
    Time Frame
    Baseline, month 1
    Title
    Glucose Change From Baseline at Month 6
    Description
    Laboratory chemistry glucose
    Time Frame
    Baseline, month 6
    Title
    Glucose Change From Baseline at Month 12
    Description
    Laboratory chemistry glucose
    Time Frame
    Baseline, month 12
    Title
    Red Blood Cells Change From Baseline at Month 1
    Description
    Laboratory hematology red blood cells
    Time Frame
    Baseline, month 1
    Title
    Red Blood Cells Change From Baseline at Month 6
    Description
    Laboratory hematology red blood cells
    Time Frame
    Baseline, month 6
    Title
    Red Blood Cells Change From Baseline at Month 12
    Description
    Laboratory hematology red blood cells
    Time Frame
    Baseline, month 12
    Title
    Hemoglobin Change From Baseline at Month 1
    Description
    Laboratory hematology hemoglobin
    Time Frame
    Baseline, month 1
    Title
    Hemoglobin Change From Baseline at Month 6
    Description
    Laboratory hematology hemoglobin
    Time Frame
    Baseline, month 6
    Title
    Hemoglobin Change From Baseline at Month 12
    Description
    Laboratory hematology hemoglobin
    Time Frame
    Baseline, month 12
    Title
    Reticulocytes Change From Baseline at Month 1
    Description
    Laboratory hematology reticulocytes
    Time Frame
    Baseline, month 1
    Title
    Reticulocytes Change From Baseline at Month 6
    Description
    Laboratory hematology reticulocytes
    Time Frame
    Baseline, month 6
    Title
    Reticulocytes Change From Baseline at Month 12
    Description
    Laboratory hematology reticulocytes
    Time Frame
    Baseline, month 12
    Title
    Platelets Change From Baseline at Month 1
    Description
    Laboratory hematology platelets
    Time Frame
    Baseline, month 1
    Title
    Platelets Change From Baseline at Month 6
    Description
    Laboratory hematology platelets
    Time Frame
    Baseline, month 6
    Title
    Platelets Change From Baseline at Month 12
    Description
    Laboratory hematology platelets
    Time Frame
    Baseline, month 12
    Title
    White Blood Cells Change From Baseline at Month 1
    Description
    Laboratory hematology white blood cells
    Time Frame
    Baseline, month 1
    Title
    White Blood Cells Change From Baseline at Month 6
    Description
    Laboratory hematology white blood cells
    Time Frame
    Baseline, month 6
    Title
    White Blood Cells Change From Baseline at Month 12
    Description
    Laboratory hematology white blood cells
    Time Frame
    Baseline, month 12
    Title
    Total Neutrophils Change From Baseline at Month 1
    Description
    Laboratory hematology total neutrophils
    Time Frame
    Baseline, month 1
    Title
    Total Neutrophils Change From Baseline at Month 6
    Description
    Laboratory hematology total neutrophils
    Time Frame
    Baseline, month 6
    Title
    Total Neutrophils Change From Baseline at Month 12
    Description
    Laboratory hematology total neutrophils
    Time Frame
    Baseline, month 12
    Title
    Eosinophils Change From Baseline at Month 1
    Description
    Laboratory hematology eosinophils
    Time Frame
    Baseline, month 1
    Title
    Eosinophils Change From Baseline at Month 6
    Description
    Laboratory hematology eosinophils
    Time Frame
    Baseline, month 6
    Title
    Eosinophils Change From Baseline at Month 12
    Description
    Laboratory hematology eosinophils
    Time Frame
    Baseline, month 12
    Title
    Basophils Change From Baseline at Month 1
    Description
    Laboratory hematology basophils
    Time Frame
    Baseline, month 1
    Title
    Basophils Change From Baseline at Month 6
    Description
    Laboratory hematology basophils
    Time Frame
    Baseline, month 6
    Title
    Basophils Change From Baseline at Month 12
    Description
    Laboratory hematology basophils
    Time Frame
    Baseline, month 12
    Title
    Lymphocytes Change From Baseline at Month 1
    Description
    Laboratory hematology lymphocytes
    Time Frame
    Baseline, month 1
    Title
    Lymphocytes Change From Baseline at Month 6
    Description
    Laboratory hematology lymphocytes
    Time Frame
    Baseline, month 6
    Title
    Lymphocytes Change From Baseline at Month 12
    Description
    Laboratory hematology lymphocytes
    Time Frame
    Baseline, month 12
    Title
    Monocytes Change From Baseline at Month 1
    Description
    Laboratory hematology monocytes
    Time Frame
    Baseline, month 1
    Title
    Monocytes Change From Baseline at Month 6
    Description
    Laboratory hematology monocytes
    Time Frame
    Baseline, month 6
    Title
    Monocytes Change From Baseline at Month 12
    Description
    Laboratory hematology monocytes
    Time Frame
    Baseline, month 12
    Title
    Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3
    Description
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    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

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