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

This study is ongoing, but not recruiting participants.

First Received: August 9, 2007 Last Updated: August 27, 2009 History of Changes

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00515463

Purpose

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).

Condition	Intervention	Phase
Low Bone Mineral Density Osteopenia Osteoporosis	Biological: denosumab	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Minerals Osteoporosis

Drug Information available for: Denosumab

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

The primary outcome is to assess the incidence of anti-denosumab antibody formation at six months. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary outcome is to assess the incidence of anti-denosumab antibody formation at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	311
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
VIAL: Experimental ~150 post menopausal women	Biological: denosumab Subjects receive 60 mg, SC, every 6 months using a standard vial
PFS: Experimental ~150 postmenopausal women	Biological: denosumab Subjects receive 60 mg, SC, every 6 months using a pre-filled syringe

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who have successfully completed the 20050141 study:

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 subject 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515463

Show 32 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20060237
Study First Received:	August 9, 2007
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00515463 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Osteopenia
Osteoporosis
AMG 162
Postmenopausal
Pre-filled syringe

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on September 04, 2009