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

Amgen

Status and phase

Completed

Phase 3

Conditions

Osteoporosis

Osteopenia

Low Bone Mineral Density

Treatments

Biological: denosumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00515463

20060237

Details and patient eligibility

About

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).

Enrollment

311 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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