DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Low Bone Mineral Density; Osteopenia; Osteoporosis

Intervention: denosumab (Biological); denosumab (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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).

Clinical Details

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

Primary outcome: Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6

Secondary outcome:

Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12

Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12

Sodium Change From Baseline at Month 1

Sodium Change From Baseline at Month 6

Sodium Change From Baseline at Month 12

Potassium Change From Baseline at Month 1

Potassium Change From Baseline at Month 6

Potassium Change From Baseline at Month 12

Chloride Change From Baseline at Month 1

Chloride Change From Baseline at Month 6

Chloride Change From Baseline at Month 12

Bicarbonate Change From Baseline at Month 1

Bicarbonate Change From Baseline at Month 6

Bicarbonate Change From Baseline at Month 12

Magnesium Change From Baseline at Month 1

Magnesium Change From Baseline at Month 6

Magnesium Change From Baseline at Month 12

Blood Urea Nitrogen Change From Baseline at Month 1

Blood Urea Nitrogen Change From Baseline at Month 6

Blood Urea Nitrogen Change From Baseline at Month 12

Creatinine Change From Baseline at Month 1

Creatinine Change From Baseline at Month 6

Creatinine Change From Baseline at Month 12

Aspartate Amino Transferase Change From Baseline at Month 1

Aspartate Amino Transferase Change From Baseline at Month 6

Aspartate Amino Transferase Change From Baseline at Month 12

Alanine Amino Transferase Change From Baseline at Month 1

Alanine Amino Transferase Change From Baseline at Month 6

Alanine Amino Transferase Change From Baseline at Month 12

Total Bilirubin Change From Baseline at Month 1

Total Bilirubin Change From Baseline at Month 6

Total Bilirubin Change From Baseline at Month 12

Albumin Change From Baseline at Month 1

Albumin Change From Baseline at Month 6

Albumin Change From Baseline at Month 12

Total Protein Change From Baseline at Month 1

Total Protein Change From Baseline at Month 6

Total Protein Change From Baseline at Month 12

Glucose Change From Baseline at Month 1

Glucose Change From Baseline at Month 6

Glucose Change From Baseline at Month 12

Red Blood Cells Change From Baseline at Month 1

Red Blood Cells Change From Baseline at Month 6

Red Blood Cells Change From Baseline at Month 12

Hemoglobin Change From Baseline at Month 1

Hemoglobin Change From Baseline at Month 6

Hemoglobin Change From Baseline at Month 12

Reticulocytes Change From Baseline at Month 1

Reticulocytes Change From Baseline at Month 6

Reticulocytes Change From Baseline at Month 12

Platelets Change From Baseline at Month 1

Platelets Change From Baseline at Month 6

Platelets Change From Baseline at Month 12

White Blood Cells Change From Baseline at Month 1

White Blood Cells Change From Baseline at Month 6

White Blood Cells Change From Baseline at Month 12

Total Neutrophils Change From Baseline at Month 1

Total Neutrophils Change From Baseline at Month 6

Total Neutrophils Change From Baseline at Month 12

Eosinophils Change From Baseline at Month 1

Eosinophils Change From Baseline at Month 6

Eosinophils Change From Baseline at Month 12

Basophils Change From Baseline at Month 1

Basophils Change From Baseline at Month 6

Basophils Change From Baseline at Month 12

Lymphocytes Change From Baseline at Month 1

Lymphocytes Change From Baseline at Month 6

Lymphocytes Change From Baseline at Month 12

Monocytes Change From Baseline at Month 1

Monocytes Change From Baseline at Month 6

Monocytes Change From Baseline at Month 12

Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Additional Information

Notice regarding posted summaries of trial results

AmgenTrials clinical trials website

Starting date: May 2007
Last updated: August 27, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017