Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
60–94
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Subjects must sign the informed consent before any study specific procedures are performed and agree to receive denosumab 60 mg subcutaneous injection every 6 months
Subjects must not have discontinued investigational product during the 20030216 study and must have attended the 20030216 study month 36 visit
Subjects must be re-consented prior to (or at) the 24 month visit for participation beyond month 24.
You may not be if
Permanently non-ambulatory subjects (use of an assistive device eg, cane, walker, etc. is permitted)
Missed 2 or more investigational product doses during the 20030216 study
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
Developed sensitivity to mammalian cell derived drug products during the 20030216 study
Unable to tolerate calcium supplementation during the last 6 months of participation in the 20030216 study (between the month 30 and month 36 20030216 study visits)
Currently receiving any investigational product other than denosumab or having received any investigational product during the 20030216 study
Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium, or tibolone
For bone biopsy sub-study subjects only: known or suspected sensitivity or contraindication to tetracycline derivatives
Clareo Health | Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis
