- Subject was previously enrolled in a denosumab phase 3 study and participated in the
Open-label Extension portion of that study.
- Subject or subject's legally acceptable representative has provided informed consent.
- Subject is of child bearing potential and planning to become pregnant within 7 months
after the end of treatment.
- Subject is of child bearing potential and is not willing to use, in combination with
her partner, two highly effective methods of contraception during treatment and for 7
months after the end of treatment.
- Subject has known sensitivity to any of the products to be administered during
- Subject will not be available for protocol required study visits or procedures, to
the best of the subject and investigator's knowledge.
- Subject has any kind of disorder that, in the opinion of the investigator, may
compromise the ability of the subject to give written informed consent and/or to
comply with all required study procedures.