A Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects With Low Bone Mineral Density

PHASE3CompletedINTERVENTIONAL
Enrollment

311

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2009

Conditions
Low Bone Mineral DensityOsteopeniaOsteoporosis
Interventions
BIOLOGICAL

denosumab

60 mg denosumab in 1mL

BIOLOGICAL

denosumab

60 mg denosumab in 1mL

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT00515463 - A Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects With Low Bone Mineral Density | Biotech Hunter | Biotech Hunter