Status:
COMPLETED
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
Lead Sponsor:
Amgen
Conditions:
Low Bone Mineral Density
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00325468
Start Date
May 1 2006
End Date
August 2 2012
Last Update
August 1 2017
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