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
NCT ID: NCT00515463
Last Updated: 2013-10-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
311 participants
INTERVENTIONAL
2007-05-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Denosumab - Vial
Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
denosumab
60 mg denosumab in 1mL
Denosumab - Prefilled syringe
Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
denosumab
60 mg denosumab in 1mL
Interventions
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denosumab
60 mg denosumab in 1mL
denosumab
60 mg denosumab in 1mL
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Countries
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Related Links
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Notice regarding posted summaries of trial results
AmgenTrials clinical trials website
Other Identifiers
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20060237
Identifier Type: -
Identifier Source: org_study_id