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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Low Bone Mineral Density Osteopenia Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Denosumab - Vial

Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.

Group Type EXPERIMENTAL

denosumab

Intervention Type BIOLOGICAL

60 mg denosumab in 1mL

Denosumab - Prefilled syringe

Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.

Group Type EXPERIMENTAL

denosumab

Intervention Type BIOLOGICAL

60 mg denosumab in 1mL

Interventions

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denosumab

60 mg denosumab in 1mL

Intervention Type BIOLOGICAL

denosumab

60 mg denosumab in 1mL

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No