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
Ambulatory, postmenopausal women
Randomized to either denosumab or placebo in the 20050179 (NCT00293813) study and completed that study (ie, attended an end of study visit)
At least 12 months have elapsed since their end of 20050179 study visit
Provide signed informed consent
You may not be if
Subjects who failed to receive both doses of denosumab (or SQ \[subcutaneous\] placebo) during the 20050179 study
Subjects who were randomized to the alendronate arm during the 20050179 study
Subjects diagnosed with any of the following conditions following completion of the 20050179 study:
Hyperthyroidism
Hyperparathyroidism
Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy
Other diseases which affect bone metabolism
Self-reported alcohol or drug abuse within the previous 12 months
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
Received any investigational product other than denosumab in two years before the screening visit.
Received \> 3 months (or equivalent) of osteoporosis treatment since having completed the 20050179 study.
Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone analogue, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone.
Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s) (other than Amgen trial 20080287), or subject is receiving other investigational agent(s).
