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Study Complete
Sponsor ID
20080540

Open Label Extension to SRE Studies in United Kingdom and Czech Republic only

Sponsor ID
20080540
Clinicaltrials.gov ID
NCT00950911
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
35
Additional Study Details

Protocol Summary

Primary Outcome Measures

To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.

Timeframe: Two years

Secondary Outcome Measures
Not Available

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Praha 5, Czech Republic, 150 06
Status
Completed
Location
Research Site
Praha 4, Czech Republic, 140 44
Status
Completed
Location
Research Site
Praha 1, Czech Republic, 110 00
Status
Completed
Location
Research Site
Zlin, Czech Republic, 762 75
Status
Completed
Location
Research Site
Olomouc, Czech Republic, 775 20
Status
Completed
Location
Research Site
Jindrichuv Hradec, Czech Republic, 377 01
Status
Completed
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Study Info
Age
18+ years
Condition
  • Prostate Cancer
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  • Breast Cancer
  • Multiple Myeloma
    • Sex
    All
    Trial Dates
    Jul 2009 - Feb 2012
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Subjects currently enrolled in study 20050103, 20050136, or 20050244 - Subjects must sign the informed consent before any study specific procedures are performed
    Exclusion Criteria:
    - Developed sensitivity to mammalian cell derived drug products during the 20050103, 20050136, or 20050244 study - 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