Clinical trial 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
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Bone Mineral Density
Osteopenia
Osteoporosis
Keywords: Osteopenia
Osteoporosis
AMG 162
Postmenopausal
Pre-filled syringe
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-08-13
Enrollment: 311
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12
timeFrame: 12 months
measure: Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12
timeFrame: Month 12
measure: Sodium Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Sodium Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Sodium Change From Baseline at Month 12
timeFrame: Baseline, Month 12
measure: Potassium Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Potassium Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Potassium Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Chloride Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Chloride Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Chloride Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Bicarbonate Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Bicarbonate Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Bicarbonate Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Magnesium Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Magnesium Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Magnesium Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Blood Urea Nitrogen Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Blood Urea Nitrogen Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Blood Urea Nitrogen Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Creatinine Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Creatinine Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Creatinine Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Aspartate Amino Transferase Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Aspartate Amino Transferase Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Aspartate Amino Transferase Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Alanine Amino Transferase Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Alanine Amino Transferase Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Alanine Amino Transferase Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Total Bilirubin Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Total Bilirubin Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Total Bilirubin Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Albumin Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Albumin Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Albumin Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Total Protein Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Total Protein Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Total Protein Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Glucose Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Glucose Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Glucose Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Red Blood Cells Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Red Blood Cells Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Red Blood Cells Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Hemoglobin Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Hemoglobin Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Hemoglobin Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Reticulocytes Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Reticulocytes Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Reticulocytes Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Platelets Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Platelets Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Platelets Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: White Blood Cells Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: White Blood Cells Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: White Blood Cells Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Total Neutrophils Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Total Neutrophils Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Total Neutrophils Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Eosinophils Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Eosinophils Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Eosinophils Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Basophils Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Basophils Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Basophils Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Lymphocytes Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Lymphocytes Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Lymphocytes Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Monocytes Change From Baseline at Month 1
timeFrame: Baseline, month 1
measure: Monocytes Change From Baseline at Month 6
timeFrame: Baseline, month 6
measure: Monocytes Change From Baseline at Month 12
timeFrame: Baseline, month 12
measure: Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3
timeFrame: Day 1 to Month 12
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: