Clareo Health | An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
