4
Participants
Start Date
November 1, 2012
Primary Completion Date
June 9, 2015
Study Completion Date
June 9, 2016
Denosumab
"Formulation of Dosage forms~The vial presentations of denosumab contain 60 mg/mL denosumab, 17 mM sodium acetate, and 4.7% (w/v) sorbitol, at a pH of 5.2, filled to a target deliverable volume of 1.0 mL; or 70 mg/mL denosumab, 18 mM sodium acetate and 4.6% (w/v) sorbitol, at a pH of 5.2, filled to a target deliverable volume of 1.7 mL. The prefilled syringe (PFS) drug product contains denosumab at 60 mg/mL, 17 mM sodium acetate, 4.7% (w/v) sorbitol, and 0.01% (w/v) polysorbate 20, at a pH of 5.2, filled to a target deliverable volume of 1.0 mL.~Dosage: 120 mg, monthly for total of 6 months, then every 12 weeks for 2 doses, for a total treatment course of one year~Route of administration: subcutaneous injection"
University of California San Francisco, San Francisco
Collaborators (1)
University of California, San Francisco
OTHER
Amgen
INDUSTRY
Hope Rugo, MD
OTHER