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Study Complete
Sponsor ID
20050233

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density

Sponsor ID
20050233
Clinicaltrials.gov ID
NCT00325468
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
200
Additional Study Details

Protocol Summary

Primary Outcome Measures

To evaluate the long-term safety outcomes of denosumab administration in postmenopausal women with low BMD who have completed 10010223 study

Timeframe: 48 months

Secondary Outcome Measures

To describe the treatment effect on BMD and BTM on long-term denosumab administration in postmenopausal women with low BMD who have completed the 20010223 study

Timeframe: 48 months

Study Documents

Study Synopsis
Available Language(s): English
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Locations

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Study Info
Age
N/A
Condition
  • Bone Loss
    • Sex
    Assigned Female at Birth
    Trial Dates
    May 2006 - Mar 2011
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    -Subject must be ambulatory -Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit -signed informed consent must be obtained before any study-specific procedures
    Exclusion Criteria:
    -Experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study. -Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment. -Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease. -Using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.