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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00515463
Recruitment Status : Completed
First Posted : August 13, 2007
Results First Posted : October 31, 2013
Last Update Posted : October 31, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

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).

Condition or disease Intervention/treatment Phase
Low Bone Mineral Density Osteopenia Osteoporosis Biological: denosumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2007
Primary Completion Date : March 2008
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Denosumab - Vial
Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
Biological: denosumab
60 mg denosumab in 1mL
Experimental: Denosumab - Prefilled syringe
Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
Biological: denosumab
60 mg denosumab in 1mL



Primary Outcome Measures :
  1. Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6 [ Time Frame: 6 months ]
    An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.


Secondary Outcome Measures :
  1. Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12 [ Time Frame: 12 months ]
    An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.

  2. Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12 [ Time Frame: Month 12 ]
    Samples demonstrating reactivity for binding antibodies to denosumab were to be tested for neutralizing or inhibitory effects in a cell-based bioassay.

  3. Sodium Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry sodium

  4. Sodium Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry sodium

  5. Sodium Change From Baseline at Month 12 [ Time Frame: Baseline, Month 12 ]
    Sodium Change From Baseline at Month 12

  6. Potassium Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry potassium

  7. Potassium Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry potassium

  8. Potassium Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry potassium

  9. Chloride Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry chloride

  10. Chloride Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry chloride

  11. Chloride Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry chloride

  12. Bicarbonate Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry bicarbonate

  13. Bicarbonate Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry bicarbonate

  14. Bicarbonate Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry bicarbonate

  15. Magnesium Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry magnesium

  16. Magnesium Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry magnesium

  17. Magnesium Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry magnesium

  18. Blood Urea Nitrogen Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry blood urea nitrogen

  19. Blood Urea Nitrogen Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry blood urea nitrogen

  20. Blood Urea Nitrogen Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry blood urea nitrogen

  21. Creatinine Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry creatinine

  22. Creatinine Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry creatinine

  23. Creatinine Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry creatinine

  24. Aspartate Amino Transferase Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry aspartate amino transferase

  25. Aspartate Amino Transferase Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry aspartate amino transferase

  26. Aspartate Amino Transferase Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry aspartate amino transferase

  27. Alanine Amino Transferase Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry alanine amino transferase

  28. Alanine Amino Transferase Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry alanine amino transferase

  29. Alanine Amino Transferase Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry alanine amino transferase

  30. Total Bilirubin Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry total bilirubin

  31. Total Bilirubin Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry total bilirubin

  32. Total Bilirubin Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry total bilirubin

  33. Albumin Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry albumin

  34. Albumin Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry albumin

  35. Albumin Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry albumin

  36. Total Protein Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry total protein

  37. Total Protein Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry total protein

  38. Total Protein Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry total protein

  39. Glucose Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry glucose

  40. Glucose Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry glucose

  41. Glucose Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry glucose

  42. Red Blood Cells Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology red blood cells

  43. Red Blood Cells Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology red blood cells

  44. Red Blood Cells Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology red blood cells

  45. Hemoglobin Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology hemoglobin

  46. Hemoglobin Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology hemoglobin

  47. Hemoglobin Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology hemoglobin

  48. Reticulocytes Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology reticulocytes

  49. Reticulocytes Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology reticulocytes

  50. Reticulocytes Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology reticulocytes

  51. Platelets Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology platelets

  52. Platelets Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology platelets

  53. Platelets Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology platelets

  54. White Blood Cells Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology white blood cells

  55. White Blood Cells Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology white blood cells

  56. White Blood Cells Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology white blood cells

  57. Total Neutrophils Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology total neutrophils

  58. Total Neutrophils Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology total neutrophils

  59. Total Neutrophils Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology total neutrophils

  60. Eosinophils Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology eosinophils

  61. Eosinophils Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology eosinophils

  62. Eosinophils Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology eosinophils

  63. Basophils Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology basophils

  64. Basophils Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology basophils

  65. Basophils Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology basophils

  66. Lymphocytes Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology lymphocytes

  67. Lymphocytes Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology lymphocytes

  68. Lymphocytes Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology lymphocytes

  69. Monocytes Change From Baseline at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology monocytes

  70. Monocytes Change From Baseline at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology monocytes

  71. Monocytes Change From Baseline at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology monocytes

  72. Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515463


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00515463     History of Changes
Other Study ID Numbers: 20060237
First Posted: August 13, 2007    Key Record Dates
Results First Posted: October 31, 2013
Last Update Posted: October 31, 2013
Last Verified: August 2013

Keywords provided by Amgen:
Osteopenia
Osteoporosis
AMG 162
Postmenopausal
Pre-filled syringe

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs