Low Bone Mineral DensityPhase 3NCT00515463
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
A Phase 3 study testing denosumab in people with Low Bone Mineral Density and Osteopenia, run by Amgen.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Low Bone Mineral Density, Osteopenia, Osteoporosis
- What is being tested?
- denosumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Mar 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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
- Being tested
- denosumab
- Keywords
- Osteopenia, Osteoporosis, AMG 162, Postmenopausal, Pre-filled syringe
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denosumabBiological
60 mg denosumab in 1mL
denosumabBiological
60 mg denosumab in 1mL
| Study group | Role | What they receive |
|---|---|---|
| Denosumab - Vial | Experimental | Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6. Receives: 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. Receives: Biological: denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (72)
Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12
An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.
Measured: 12 months
Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12
Samples demonstrating reactivity for binding antibodies to denosumab were to be tested for neutralizing or inhibitory effects in a cell-based bioassay.
Measured: Month 12
Sodium Change From Baseline at Month 1
Laboratory chemistry sodium
Measured: Baseline, month 1
Sodium Change From Baseline at Month 6
Laboratory chemistry sodium
Measured: Baseline, month 6
Sodium Change From Baseline at Month 12
Sodium Change From Baseline at Month 12
Measured: Baseline, Month 12
Potassium Change From Baseline at Month 1
Laboratory chemistry potassium
Measured: Baseline, month 1
Potassium Change From Baseline at Month 6
Laboratory chemistry potassium
Measured: Baseline, month 6
Potassium Change From Baseline at Month 12
Laboratory chemistry potassium
Measured: Baseline, month 12
Chloride Change From Baseline at Month 1
Laboratory chemistry chloride
Measured: Baseline, month 1
Chloride Change From Baseline at Month 6
Laboratory chemistry chloride
Measured: Baseline, month 6
Chloride Change From Baseline at Month 12
Laboratory chemistry chloride
Measured: Baseline, month 12
Bicarbonate Change From Baseline at Month 1
Laboratory chemistry bicarbonate
Measured: Baseline, month 1
Bicarbonate Change From Baseline at Month 6
Laboratory chemistry bicarbonate
Measured: Baseline, month 6
Bicarbonate Change From Baseline at Month 12
Laboratory chemistry bicarbonate
Measured: Baseline, month 12
Magnesium Change From Baseline at Month 1
Laboratory chemistry magnesium
Measured: Baseline, month 1
Magnesium Change From Baseline at Month 6
Laboratory chemistry magnesium
Measured: Baseline, month 6
Magnesium Change From Baseline at Month 12
Laboratory chemistry magnesium
Measured: Baseline, month 12
Blood Urea Nitrogen Change From Baseline at Month 1
Laboratory chemistry blood urea nitrogen
Measured: Baseline, month 1
Blood Urea Nitrogen Change From Baseline at Month 6
Laboratory chemistry blood urea nitrogen
Measured: Baseline, month 6
Blood Urea Nitrogen Change From Baseline at Month 12
Laboratory chemistry blood urea nitrogen
Measured: Baseline, month 12
Creatinine Change From Baseline at Month 1
Laboratory chemistry creatinine
Measured: Baseline, month 1
Creatinine Change From Baseline at Month 6
Laboratory chemistry creatinine
Measured: Baseline, month 6
Creatinine Change From Baseline at Month 12
Laboratory chemistry creatinine
Measured: Baseline, month 12
Aspartate Amino Transferase Change From Baseline at Month 1
Laboratory chemistry aspartate amino transferase
Measured: Baseline, month 1
Aspartate Amino Transferase Change From Baseline at Month 6
Laboratory chemistry aspartate amino transferase
Measured: Baseline, month 6
Aspartate Amino Transferase Change From Baseline at Month 12
Laboratory chemistry aspartate amino transferase
Measured: Baseline, month 12
Alanine Amino Transferase Change From Baseline at Month 1
Laboratory chemistry alanine amino transferase
Measured: Baseline, month 1
Alanine Amino Transferase Change From Baseline at Month 6
Laboratory chemistry alanine amino transferase
Measured: Baseline, month 6
Alanine Amino Transferase Change From Baseline at Month 12
Laboratory chemistry alanine amino transferase
Measured: Baseline, month 12
Total Bilirubin Change From Baseline at Month 1
Laboratory chemistry total bilirubin
Measured: Baseline, month 1
Total Bilirubin Change From Baseline at Month 6
Laboratory chemistry total bilirubin
Measured: Baseline, month 6
Total Bilirubin Change From Baseline at Month 12
Laboratory chemistry total bilirubin
Measured: Baseline, month 12
Albumin Change From Baseline at Month 1
Laboratory chemistry albumin
Measured: Baseline, month 1
Albumin Change From Baseline at Month 6
Laboratory chemistry albumin
Measured: Baseline, month 6
Albumin Change From Baseline at Month 12
Laboratory chemistry albumin
Measured: Baseline, month 12
Total Protein Change From Baseline at Month 1
Laboratory chemistry total protein
Measured: Baseline, month 1
Total Protein Change From Baseline at Month 6
Laboratory chemistry total protein
Measured: Baseline, month 6
Total Protein Change From Baseline at Month 12
Laboratory chemistry total protein
Measured: Baseline, month 12
Glucose Change From Baseline at Month 1
Laboratory chemistry glucose
Measured: Baseline, month 1
Glucose Change From Baseline at Month 6
Laboratory chemistry glucose
Measured: Baseline, month 6
Glucose Change From Baseline at Month 12
Laboratory chemistry glucose
Measured: Baseline, month 12
Red Blood Cells Change From Baseline at Month 1
Laboratory hematology red blood cells
Measured: Baseline, month 1
Red Blood Cells Change From Baseline at Month 6
Laboratory hematology red blood cells
Measured: Baseline, month 6
Red Blood Cells Change From Baseline at Month 12
Laboratory hematology red blood cells
Measured: Baseline, month 12
Hemoglobin Change From Baseline at Month 1
Laboratory hematology hemoglobin
Measured: Baseline, month 1
Hemoglobin Change From Baseline at Month 6
Laboratory hematology hemoglobin
Measured: Baseline, month 6
Hemoglobin Change From Baseline at Month 12
Laboratory hematology hemoglobin
Measured: Baseline, month 12
Reticulocytes Change From Baseline at Month 1
Laboratory hematology reticulocytes
Measured: Baseline, month 1
Reticulocytes Change From Baseline at Month 6
Laboratory hematology reticulocytes
Measured: Baseline, month 6
Reticulocytes Change From Baseline at Month 12
Laboratory hematology reticulocytes
Measured: Baseline, month 12
Platelets Change From Baseline at Month 1
Laboratory hematology platelets
Measured: Baseline, month 1
Platelets Change From Baseline at Month 6
Laboratory hematology platelets
Measured: Baseline, month 6
Platelets Change From Baseline at Month 12
Laboratory hematology platelets
Measured: Baseline, month 12
White Blood Cells Change From Baseline at Month 1
Laboratory hematology white blood cells
Measured: Baseline, month 1
White Blood Cells Change From Baseline at Month 6
Laboratory hematology white blood cells
Measured: Baseline, month 6
White Blood Cells Change From Baseline at Month 12
Laboratory hematology white blood cells
Measured: Baseline, month 12
Total Neutrophils Change From Baseline at Month 1
Laboratory hematology total neutrophils
Measured: Baseline, month 1
Total Neutrophils Change From Baseline at Month 6
Laboratory hematology total neutrophils
Measured: Baseline, month 6
Total Neutrophils Change From Baseline at Month 12
Laboratory hematology total neutrophils
Measured: Baseline, month 12
Eosinophils Change From Baseline at Month 1
Laboratory hematology eosinophils
Measured: Baseline, month 1
Eosinophils Change From Baseline at Month 6
Laboratory hematology eosinophils
Measured: Baseline, month 6
Eosinophils Change From Baseline at Month 12
Laboratory hematology eosinophils
Measured: Baseline, month 12
Basophils Change From Baseline at Month 1
Laboratory hematology basophils
Measured: Baseline, month 1
Basophils Change From Baseline at Month 6
Laboratory hematology basophils
Measured: Baseline, month 6
Basophils Change From Baseline at Month 12
Laboratory hematology basophils
Measured: Baseline, month 12
Lymphocytes Change From Baseline at Month 1
Laboratory hematology lymphocytes
Measured: Baseline, month 1
Lymphocytes Change From Baseline at Month 6
Laboratory hematology lymphocytes
Measured: Baseline, month 6
Lymphocytes Change From Baseline at Month 12
Laboratory hematology lymphocytes
Measured: Baseline, month 12
Monocytes Change From Baseline at Month 1
Laboratory hematology monocytes
Measured: Baseline, month 1
Monocytes Change From Baseline at Month 6
Laboratory hematology monocytes
Measured: Baseline, month 6
Monocytes Change From Baseline at Month 12
Laboratory hematology monocytes
Measured: Baseline, month 12
Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3
Participants with laboratory toxicity grade 3 (severe) or 4 (life-threatening), based on the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Measured: Day 1 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionMar 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Bone Mineral DensityStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515463
- Sponsor's protocol ID
- 20060237
- Status last verified
- Aug 2013
- First submitted
- 9 Aug 2007
- Last updated
- 31 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00515463
- Acronym / sponsor ID
- 20060237
- Conditions
- Low Bone Mineral Density, Osteopenia, Osteoporosis
- Keywords
- Osteopenia, Osteoporosis, AMG 162, Postmenopausal, Pre-filled syringe
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 13 Aug 2007 (estimated)
- Results
- Posted 31 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab - Vial | Experimental | Biological: denosumabParticipants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6. |
| Denosumab - Prefilled syringe | Experimental | Biological: denosumabParticipants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have successfully completed the 20050141 study (NCT00330460):
- Provide signed informed consent before any study-specific procedures are conducted
Key exclusion criteria (10 listed)
- 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 clinical evidence, in the medical judgement of the investigator, of the following medical conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| denosumab60 mg denosumab in 1mL | Biological | Denosumab - Vial |
| denosumab60 mg denosumab in 1mL | Biological | Denosumab - Prefilled syringe |
Primary outcome
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.
72 secondary outcomes
Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12
Time frame: 12 months
Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12
Time frame: Month 12
Sodium Change From Baseline at Month 1
Time frame: Baseline, month 1
Sodium Change From Baseline at Month 6
Time frame: Baseline, month 6
Sodium Change From Baseline at Month 12
Time frame: Baseline, Month 12
Potassium Change From Baseline at Month 1
Time frame: Baseline, month 1
Potassium Change From Baseline at Month 6
Time frame: Baseline, month 6
Potassium Change From Baseline at Month 12
Time frame: Baseline, month 12
Chloride Change From Baseline at Month 1
Time frame: Baseline, month 1
Chloride Change From Baseline at Month 6
Time frame: Baseline, month 6
Chloride Change From Baseline at Month 12
Time frame: Baseline, month 12
Bicarbonate Change From Baseline at Month 1
Time frame: Baseline, month 1
Bicarbonate Change From Baseline at Month 6
Time frame: Baseline, month 6
Bicarbonate Change From Baseline at Month 12
Time frame: Baseline, month 12
Magnesium Change From Baseline at Month 1
Time frame: Baseline, month 1
Magnesium Change From Baseline at Month 6
Time frame: Baseline, month 6
Magnesium Change From Baseline at Month 12
Time frame: Baseline, month 12
Blood Urea Nitrogen Change From Baseline at Month 1
Time frame: Baseline, month 1
Blood Urea Nitrogen Change From Baseline at Month 6
Time frame: Baseline, month 6
Blood Urea Nitrogen Change From Baseline at Month 12
Time frame: Baseline, month 12
Creatinine Change From Baseline at Month 1
Time frame: Baseline, month 1
Creatinine Change From Baseline at Month 6
Time frame: Baseline, month 6
Creatinine Change From Baseline at Month 12
Time frame: Baseline, month 12
Aspartate Amino Transferase Change From Baseline at Month 1
Time frame: Baseline, month 1
Aspartate Amino Transferase Change From Baseline at Month 6
Time frame: Baseline, month 6
Aspartate Amino Transferase Change From Baseline at Month 12
Time frame: Baseline, month 12
Alanine Amino Transferase Change From Baseline at Month 1
Time frame: Baseline, month 1
Alanine Amino Transferase Change From Baseline at Month 6
Time frame: Baseline, month 6
Alanine Amino Transferase Change From Baseline at Month 12
Time frame: Baseline, month 12
Total Bilirubin Change From Baseline at Month 1
Time frame: Baseline, month 1
Total Bilirubin Change From Baseline at Month 6
Time frame: Baseline, month 6
Total Bilirubin Change From Baseline at Month 12
Time frame: Baseline, month 12
Albumin Change From Baseline at Month 1
Time frame: Baseline, month 1
Albumin Change From Baseline at Month 6
Time frame: Baseline, month 6
Albumin Change From Baseline at Month 12
Time frame: Baseline, month 12
Total Protein Change From Baseline at Month 1
Time frame: Baseline, month 1
Total Protein Change From Baseline at Month 6
Time frame: Baseline, month 6
Total Protein Change From Baseline at Month 12
Time frame: Baseline, month 12
Glucose Change From Baseline at Month 1
Time frame: Baseline, month 1
Glucose Change From Baseline at Month 6
Time frame: Baseline, month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing denosumab in people with Low Bone Mineral Density and Osteopenia, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2013.