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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00515463
• Other study ID #: 20060237
• Status: Completed
• Phase: Phase 3
• First received: August 9, 2007
• Last updated: August 27, 2013
• Start date: May 2007
• Est. completion date: March 2009

Study information

• Verified date: August 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug AdministrationUnited States: Schulman Associates IRB
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: March 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Bone Mineral Density
• Osteopenia
• Osteoporosis

Intervention

Biological:
• denosumab
60 mg denosumab in 1mL
• denosumab
60 mg denosumab in 1mL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

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

External Links

•   AmgenTrials clinical trials website