Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
NCT ID: NCT00950911
Last Updated: 2014-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
35 participants
INTERVENTIONAL
2009-07-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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1
amg 162
120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.
Interventions
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amg 162
120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.
Eligibility Criteria
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Inclusion Criteria
* Subjects must sign the informed consent before any study specific procedures are performed
Exclusion Criteria
* Currently receiving any unapproved investigational product other than denosumab
* Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment
* Subject (male or female) is not willing to use 2 highly effective contraception during treatment and for 7 months (women) or 10 months (men) after the end of treatment
* Male subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment
* Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
18 Years
ALL
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
Locations
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Research Site
Jindřichův Hradec, , Czechia
Research Site
Kroměříž, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Zlín, , Czechia
Research Site
Chichester, , United Kingdom
Research Site
Leeds, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Northwood, , United Kingdom
Research Site
Peterborough, , United Kingdom
Research Site
York, , United Kingdom
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20080540
Identifier Type: -
Identifier Source: org_study_id
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