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Completed

NCT Number: NCT00515463

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 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).

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Key information

Conditions

Low Bone Mineral Density Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia Osteoporosis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Denosumab

Biological

60 mg denosumab in 1mL

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Aug 13, 2007
Registry last updated
Oct 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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