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

NCT00515463 | Completed Phase 3 Results

• 1 other identifier: 20060237
• Study Type: interventional
• Target: 311
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Low Bone Mineral Density; Osteopenia; Osteoporosis

Keywords

Osteopenia; Osteoporosis; AMG 162; Postmenopausal; Pre-filled syringe

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6

  An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.

  6 months

Secondary Outcomes (72)

• Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12

  12 months

• Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12

  Month 12

• Sodium Change From Baseline at Month 1

  Baseline, month 1

• Sodium Change From Baseline at Month 6

  Baseline, month 6

• Sodium Change From Baseline at Month 12

  Baseline, Month 12

Study Arms (2)

Denosumab - Vial

EXPERIMENTAL

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

Biological: denosumab

Denosumab - Prefilled syringe

EXPERIMENTAL

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

Biological: denosumab

Interventions

denosumab BIOLOGICAL

60 mg denosumab in 1mL

Denosumab - Vial

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Amgen: lead

Related Links

• Notice regarding posted summaries of trial results
• AmgenTrials clinical trials website

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2007
• First Posted: August 13, 2007
• Study Start: May 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2009
• Last Updated: October 31, 2013
• Results First Posted: October 31, 2013

Record last verified: 2013-08