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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2013-10-31

Study results available
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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

Interventions

BIOLOGICAL

denosumab

60 mg denosumab in 1mL

BIOLOGICAL

denosumab

60 mg denosumab in 1mL

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-03-31
Completion
2009-03-31

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00515463 on ClinicalTrials.gov