Clareo Health | 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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
