Phase 3
Completed N=311
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
Low Bone Mineral Density · osteopenia · Osteoporosis
Source: ClinicalTrials.gov NCT00515463 ↗
Enrolled (actual)
311
Serious AEs
6.1%
Results posted
Oct 2013
Primary outcomePrimary: Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6 — 0; 0 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6 |
0; 0 | — |
| SECONDARY Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12 |
0; 0 | — |
| SECONDARY Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12 |
— | — |
| SECONDARY Sodium Change From Baseline at Month 1 |
-0.1; 0.1 | — |
| SECONDARY Sodium Change From Baseline at Month 6 |
-1.2; -0.9 | — |
| SECONDARY Sodium Change From Baseline at Month 12 |
-0.9; -0.6 | — |
| SECONDARY Potassium Change From Baseline at Month 1 |
0.02; 0 | — |
| SECONDARY Potassium Change From Baseline at Month 6 |
0.01; -0.07 | — |
| SECONDARY Potassium Change From Baseline at Month 12 |
0.07; 0.04 | — |
| SECONDARY Chloride Change From Baseline at Month 1 |
-0.1; 0.2 | — |
| SECONDARY Chloride Change From Baseline at Month 6 |
-0.9; -0.4 | — |
| SECONDARY Chloride Change From Baseline at Month 12 |
-0.2; 0 | — |
| SECONDARY Bicarbonate Change From Baseline at Month 1 |
-0.3; 0 | — |
| SECONDARY Bicarbonate Change From Baseline at Month 6 |
0.2; 0.1 | — |
| SECONDARY Bicarbonate Change From Baseline at Month 12 |
-0.6; -0.1 | — |
| SECONDARY Magnesium Change From Baseline at Month 1 |
0.001; -0.010 | — |
| SECONDARY Magnesium Change From Baseline at Month 6 |
-0.053; -0.064 | — |
| SECONDARY Magnesium Change From Baseline at Month 12 |
-0.053; -0.055 | — |
| SECONDARY Blood Urea Nitrogen Change From Baseline at Month 1 |
0.01; -0.04 | — |
| SECONDARY Blood Urea Nitrogen Change From Baseline at Month 6 |
0.09; 0.11 | — |
| SECONDARY Blood Urea Nitrogen Change From Baseline at Month 12 |
0.27; -0.02 | — |
| SECONDARY Creatinine Change From Baseline at Month 1 |
0.24; 0.12 | — |
| SECONDARY Creatinine Change From Baseline at Month 6 |
-0.19; -1.29 | — |
| SECONDARY Creatinine Change From Baseline at Month 12 |
1.40; 0.76 | — |
| SECONDARY Aspartate Amino Transferase Change From Baseline at Month 1 |
-1.6; 0.4 | — |
| SECONDARY Aspartate Amino Transferase Change From Baseline at Month 6 |
-1.6; 0.9 | — |
| SECONDARY Aspartate Amino Transferase Change From Baseline at Month 12 |
-1.9; 0.2 | — |
| SECONDARY Alanine Amino Transferase Change From Baseline at Month 1 |
-3.1; 0.5 | — |
| SECONDARY Alanine Amino Transferase Change From Baseline at Month 6 |
-1.4; 4.2 | — |
| SECONDARY Alanine Amino Transferase Change From Baseline at Month 12 |
-2.7; 1.5 | — |
| SECONDARY Total Bilirubin Change From Baseline at Month 1 |
-0.35; -0.02 | — |
| SECONDARY Total Bilirubin Change From Baseline at Month 6 |
-0.30; -0.20 | — |
| SECONDARY Total Bilirubin Change From Baseline at Month 12 |
0.16; 0.64 | — |
| SECONDARY Albumin Change From Baseline at Month 1 |
-0.46; -0.40 | — |
| SECONDARY Albumin Change From Baseline at Month 6 |
-0.34; -0.51 | — |
| SECONDARY Albumin Change From Baseline at Month 12 |
-0.26; 0 | — |
| SECONDARY Total Protein Change From Baseline at Month 1 |
-0.59; -0.54 | — |
| SECONDARY Total Protein Change From Baseline at Month 6 |
-0.58; -0.80 | — |
| SECONDARY Total Protein Change From Baseline at Month 12 |
-1.35; -0.91 | — |
| SECONDARY Glucose Change From Baseline at Month 1 |
-0.08; 0.03 | — |
| SECONDARY Glucose Change From Baseline at Month 6 |
-0.08; 0.05 | — |
| SECONDARY Glucose Change From Baseline at Month 12 |
-0.06; 0.08 | — |
| SECONDARY Red Blood Cells Change From Baseline at Month 1 |
0; 0.02 | — |
| SECONDARY Red Blood Cells Change From Baseline at Month 6 |
0.04; 0.04 | — |
| SECONDARY Red Blood Cells Change From Baseline at Month 12 |
-0.01; 0.02 | — |
| SECONDARY Hemoglobin Change From Baseline at Month 1 |
-0.97; -0.42 | — |
| SECONDARY Hemoglobin Change From Baseline at Month 6 |
0.84; 0.96 | — |
| SECONDARY Hemoglobin Change From Baseline at Month 12 |
-1.74; -0.22 | — |
| SECONDARY Reticulocytes Change From Baseline at Month 1 |
3.70; 1.69 | — |
| SECONDARY Reticulocytes Change From Baseline at Month 6 |
19.54; 15.21 | — |
| SECONDARY Reticulocytes Change From Baseline at Month 12 |
19.09; 15.08 | — |
| SECONDARY Platelets Change From Baseline at Month 1 |
5.24; 2.48 | — |
| SECONDARY Platelets Change From Baseline at Month 6 |
28.26; 21.49 | — |
| SECONDARY Platelets Change From Baseline at Month 12 |
25.19; 15.60 | — |
| SECONDARY White Blood Cells Change From Baseline at Month 1 |
0.23; 0.01 | — |
| SECONDARY White Blood Cells Change From Baseline at Month 6 |
0.22; -0.08 | — |
| SECONDARY White Blood Cells Change From Baseline at Month 12 |
0.47; 0.24 | — |
| SECONDARY Total Neutrophils Change From Baseline at Month 1 |
0.11; -0.03 | — |
| SECONDARY Total Neutrophils Change From Baseline at Month 6 |
0.21; -0.02 | — |
| SECONDARY Total Neutrophils Change From Baseline at Month 12 |
0.38; 0.12 | — |
| SECONDARY Eosinophils Change From Baseline at Month 1 |
-0.002; -0.010 | — |
| SECONDARY Eosinophils Change From Baseline at Month 6 |
0.020; 0.013 | — |
| SECONDARY Eosinophils Change From Baseline at Month 12 |
-0.008; 0.025 | — |
| SECONDARY Basophils Change From Baseline at Month 1 |
0.001; 0 | — |
| SECONDARY Basophils Change From Baseline at Month 6 |
0.012; 0.012 | — |
| SECONDARY Basophils Change From Baseline at Month 12 |
0.003; 0.006 | — |
| SECONDARY Lymphocytes Change From Baseline at Month 1 |
0.12; 0.04 | — |
| SECONDARY Lymphocytes Change From Baseline at Month 6 |
0.01; -0.06 | — |
| SECONDARY Lymphocytes Change From Baseline at Month 12 |
0.08; 0.06 | — |
| SECONDARY Monocytes Change From Baseline at Month 1 |
0; 0.01 | — |
| SECONDARY Monocytes Change From Baseline at Month 6 |
-0.03; -0.03 | — |
| SECONDARY Monocytes Change From Baseline at Month 12 |
0.01; 0.03 | — |
| SECONDARY Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3 |
2; 2; 0; 1; 0; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00515463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.