An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Low Bone Mineral Density
Intervention: AMG 162 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
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
Clinical Details
Official title: An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
Secondary outcome: Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Additional Information
AmgenTrials clinical trials website
Starting date: May 2006
Last updated: December 4, 2013
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