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

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

The purpose of this study is to compare the immunogenicity profiles of denosumab pre-filled syringe (PFS) and vial at 6 months in postmenopausal women with low bone mineral density (BMD).

Inclusion Criteria:

• Patients who have successfully completed the 20050141 study (NCT00330460):

  • Must have received all SC investigational product administrations in 20050141
  • Must not have taken any proscribed therapies in 20050141
  • Subjects who were in the alendronate or denosumab treatment group are allowed

• Provide signed informed consent before any study-specific procedures are conducted

Exclusion Criteria:

• Any disorder that, in the opinion of the investigator, may compromise the ability of the patient to give written informed consent and/or comply with study procedures including:

  • Any physical or psychiatric disorder
  • Or evidence of alcohol or substance abuse in the last 12 months

• Any clinical evidence, in the medical judgement of the investigator, of the following medical conditions:

  • Impaired thyroid function (subsequent to treatment)
  • Impaired hepatic function
  • Impaired renal function
  • Rheumatoid Arthritis, Paget's disease, Cushing's disease, hyperprolactinemia, or cirrhosis of the liver
  • Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen
  • Any metabolic bone disease, eg, osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings