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

August 27, 2013 updated by: Amgen
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
311

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Denosumab - Vial
Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
Biological: denosumab
60 mg denosumab in 1mL
Experimental: Denosumab - Prefilled syringe
Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
Biological: denosumab
60 mg denosumab in 1mL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6
Time Frame: 6 months
An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12
Time Frame: 12 months
An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.
12 months
Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12
Time Frame: Month 12
Samples demonstrating reactivity for binding antibodies to denosumab were to be tested for neutralizing or inhibitory effects in a cell-based bioassay.
Month 12
Sodium Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory chemistry sodium
Baseline, month 1
Sodium Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory chemistry sodium
Baseline, month 6
Sodium Change From Baseline at Month 12
Time Frame: Baseline, Month 12
Sodium Change From Baseline at Month 12
Baseline, Month 12
Potassium Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory chemistry potassium
Baseline, month 1
Potassium Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory chemistry potassium
Baseline, month 6
Potassium Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory chemistry potassium
Baseline, month 12
Chloride Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory chemistry chloride
Baseline, month 1
Chloride Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory chemistry chloride
Baseline, month 6
Chloride Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory chemistry chloride
Baseline, month 12
Bicarbonate Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory chemistry bicarbonate
Baseline, month 1
Bicarbonate Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory chemistry bicarbonate
Baseline, month 6
Bicarbonate Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory chemistry bicarbonate
Baseline, month 12
Magnesium Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory chemistry magnesium
Baseline, month 1
Magnesium Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory chemistry magnesium
Baseline, month 6
Magnesium Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory chemistry magnesium
Baseline, month 12
Blood Urea Nitrogen Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory chemistry blood urea nitrogen
Baseline, month 1
Blood Urea Nitrogen Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory chemistry blood urea nitrogen
Baseline, month 6
Blood Urea Nitrogen Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory chemistry blood urea nitrogen
Baseline, month 12
Creatinine Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory chemistry creatinine
Baseline, month 1
Creatinine Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory chemistry creatinine
Baseline, month 6
Creatinine Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory chemistry creatinine
Baseline, month 12
Aspartate Amino Transferase Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory chemistry aspartate amino transferase
Baseline, month 1
Aspartate Amino Transferase Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory chemistry aspartate amino transferase
Baseline, month 6
Aspartate Amino Transferase Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory chemistry aspartate amino transferase
Baseline, month 12
Alanine Amino Transferase Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory chemistry alanine amino transferase
Baseline, month 1
Alanine Amino Transferase Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory chemistry alanine amino transferase
Baseline, month 6
Alanine Amino Transferase Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory chemistry alanine amino transferase
Baseline, month 12
Total Bilirubin Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory chemistry total bilirubin
Baseline, month 1
Total Bilirubin Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory chemistry total bilirubin
Baseline, month 6
Total Bilirubin Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory chemistry total bilirubin
Baseline, month 12
Albumin Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory chemistry albumin
Baseline, month 1
Albumin Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory chemistry albumin
Baseline, month 6
Albumin Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory chemistry albumin
Baseline, month 12
Total Protein Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory chemistry total protein
Baseline, month 1
Total Protein Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory chemistry total protein
Baseline, month 6
Total Protein Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory chemistry total protein
Baseline, month 12
Glucose Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory chemistry glucose
Baseline, month 1
Glucose Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory chemistry glucose
Baseline, month 6
Glucose Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory chemistry glucose
Baseline, month 12
Red Blood Cells Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory hematology red blood cells
Baseline, month 1
Red Blood Cells Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory hematology red blood cells
Baseline, month 6
Red Blood Cells Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory hematology red blood cells
Baseline, month 12
Hemoglobin Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory hematology hemoglobin
Baseline, month 1
Hemoglobin Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory hematology hemoglobin
Baseline, month 6
Hemoglobin Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory hematology hemoglobin
Baseline, month 12
Reticulocytes Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory hematology reticulocytes
Baseline, month 1
Reticulocytes Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory hematology reticulocytes
Baseline, month 6
Reticulocytes Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory hematology reticulocytes
Baseline, month 12
Platelets Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory hematology platelets
Baseline, month 1
Platelets Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory hematology platelets
Baseline, month 6
Platelets Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory hematology platelets
Baseline, month 12
White Blood Cells Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory hematology white blood cells
Baseline, month 1
White Blood Cells Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory hematology white blood cells
Baseline, month 6
White Blood Cells Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory hematology white blood cells
Baseline, month 12
Total Neutrophils Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory hematology total neutrophils
Baseline, month 1
Total Neutrophils Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory hematology total neutrophils
Baseline, month 6
Total Neutrophils Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory hematology total neutrophils
Baseline, month 12
Eosinophils Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory hematology eosinophils
Baseline, month 1
Eosinophils Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory hematology eosinophils
Baseline, month 6
Eosinophils Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory hematology eosinophils
Baseline, month 12
Basophils Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory hematology basophils
Baseline, month 1
Basophils Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory hematology basophils
Baseline, month 6
Basophils Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory hematology basophils
Baseline, month 12
Lymphocytes Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory hematology lymphocytes
Baseline, month 1
Lymphocytes Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory hematology lymphocytes
Baseline, month 6
Lymphocytes Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory hematology lymphocytes
Baseline, month 12
Monocytes Change From Baseline at Month 1
Time Frame: Baseline, month 1
Laboratory hematology monocytes
Baseline, month 1
Monocytes Change From Baseline at Month 6
Time Frame: Baseline, month 6
Laboratory hematology monocytes
Baseline, month 6
Monocytes Change From Baseline at Month 12
Time Frame: Baseline, month 12
Laboratory hematology monocytes
Baseline, month 12
Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3
Time Frame: Day 1 to Month 12
Participants with laboratory toxicity grade 3 (severe) or 4 (life-threatening), based on the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Day 1 to Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20060237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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