Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis
Study Details
Study Description
Brief Summary
This study will determine the efficacy, safety, and tolerability of denosumab (AMG 162) in the treatment of Rheumatoid Arthritis (RA).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Denosumab 180 mg Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. |
Drug: denosumab
For subcutaneous injection
Other Names:
|
Experimental: Denosumab 60 mg Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. |
Drug: denosumab
For subcutaneous injection
Other Names:
|
Placebo Comparator: Placebo Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Drug: placebo
placebo subcutaneous injection
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Rheumatoid Arthritis Erosion Score Measured From MRI Assessments (RA-MRI ES) at Month 6 [Baseline, Month 6]
Fifteen sites in each wrist and 10 sites in each hand were assessed by a blinded and independent reader. Each site was scored from 0 to 10 (in accordance with the European League Against Rheumatism [EULAR]-Outcome Measures in Rheumatology Clinical Trials convention), with each unit increment representing 10% incremental loss of the peripheral 1 cm of articular bone. The Erosion Score is a sum of erosion scores from 50 joint sites in both hands/wrists and ranges from 0 (normal, no erosion) to 500 (worst possible erosion).
Secondary Outcome Measures
- Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 12 [Baseline, Month 12]
TSS is the sum of erosion and joint space narrowing scores obtained from radiographs of the hands and feet, assessed by 2 independent readers. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The TSS ranged from 0 (normal) to 448 (worst).
- Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 6 [Baseline, Month 6]
TSS is the sum of erosion and joint space narrowing scores obtained from radiographs of the hands and feet, assessed by 2 independent readers. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The TSS ranged from 0 (normal) to 448 (worst).
- Change From Baseline in Radiographic Erosion Score at Month 12 [Baseline, Month 12]
The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet, obtained from radiographs of the hands and feet and assessed by 2 independent readers. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280.
- Change From Baseline in Radiographic Erosion Score at Month 6 [Baseline, Month 6]
The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet, obtained from radiographs of the hands and feet and assessed by 2 independent readers. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280.
- Change From Baseline in Radiographic Joint Space Narrowing Score at Month 12 [Baseline, Month 12]
Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet obtained from radiographs of the hands and feet and assessed by 2 independent readers. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score (indicating worst joint space narrowing) of 168.
- Change From Baseline in Radiographic Joint Space Narrowing Score at Month 6 [Baseline, Month 6]
Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet obtained from radiographs of the hands and feet and assessed by 2 independent readers. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score (indicating worst joint space narrowing) of 168.
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 1 [Baseline, Month 1]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((month 1 value - baseline value) / baseline value ) x 100. Least squares means are based on a repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 6 [Baseline, month 6]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to month 6 calculated using ((month 6 value - baseline value) / baseline value ) x 100. Least squares means are based on a repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 [Baseline, Month 12]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).
- Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 1 [Baseline, Month 1]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((Month 1 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).
- Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 6 [Baseline, Month 6]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 6 calculated using ((Month 6 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).
- Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 12 [Baseline, Month 12]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).
- Percent Change From Baseline in Total Hip Bone Mineral Density at Month 1 [Baseline, Month 1]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((Month 1 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).
- Percent Change From Baseline in Total Hip Bone Mineral Density at Month 6 [Baseline, Month 6]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 6 calculated using ((Month 6 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).
- Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12 [Baseline, Month 12]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).
- Percent Change From Baseline in Serum Collagen C-Telopeptide (CTX) at Month 3 [Baseline, Month 3]
Percent change from baseline to Month 3 in serum Collagen C-Telopeptide (CTX) Type I calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.
- Percent Change From Baseline in Serum CTX at Month 6 [Baseline, Month 6]
Percent change from baseline to Month 6 in serum Collagen C-Telopeptide (CTX) Type I calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.
- Percent Change From Baseline in Serum CTX at Month 12 [Baseline, Month 12]
Percent change from Baseline to Month 12 in serum C-Telopeptide (CTX) Type I calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
- Percent Change From Baseline in Procollagen 1 N-terminal Peptide (P1NP) at Month 3 [Baseline, Month 3]
Percent change from baseline to Month 3 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.
- Percent Change From Baseline in P1NP at Month 6 [Baseline, Month 6]
Percent change from baseline to Month 6 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.
- Percent Change From Baseline in P1NP at Month 12 [Baseline, Month 12]
Percent change from baseline to Month 12 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
- Percent Change From Baseline in Urine Type II Collagen C-telopeptide (C-Tx) /Creatinine at Month 3 [Baseline, Month 3]
Percent change from baseline to Month 3 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.
- Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 6 [Baseline, Month 6]
Percent change from baseline to Month 6 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.
- Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 12 [Baseline, Month 12]
Percent change from baseline to Month 12 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
- Number of Participants With Anti-Denosumab Binding Antibodies [Assessed at Baseline and at Months 1, 3, 6 and 12.]
Serum from participants was tested for antibodies to denosumab by immuoassay at months 1, 3, 6 and 12. The number of participants with anti-denosumab antibodies at any assessment is reported.
- Number of Participants With Anti-Denosumab Binding Antibody and Neutralizing Antibody [Baseline to Month 12]
Serum from participants testing positive for anti-denosumab binding antibodies was tested in a cell-based bioassay for neutralizing activity against denosumab.
- Change From Baseline in Albumin at Month 1 [Baseline, month 1]
Laboratory Chemistry Albumin
- Change From Baseline in Albumin at Month 3 [Baseline, month 3]
Laboratory chemistry albumin
- Change From Baseline in Albumin at Month 6 [Baseline, month 6]
Laboratory chemistry albumin
- Change From Baseline in Albumin at Month 12 [Baseline, month 12]
Laboratory chemistry albumin
- Change From Baseline in Alkaline Phosphatase at Month 1 [Baseline, month 1]
Laboratory chemistry alkaline phoshatatse
- Change From Baseline in Alkaline Phosphatase at Month 3 [baseline, month 3]
Laboratory chemisrty alkaline phosphatase
- Change From Baseline in Alkaline Phosphatase at Month 6 [baseline, month 6]
Laboratory chemistry alkaline phosphatase
- Change From Baseline in Alkaline Phosphatase at Month 12 [baseine, month 12]
Laboratory chemistry alkaline phosphatase
- Change From Baseline in Bicarbonate at Month 1 [baseline, month 1]
Laboratory chemistry bicarbonate
- Change From Baseline in Bicarbonate at Month 3 [baseline, month 3]
Laboratory chemistry bicarbonate
- Change From Baseline in Bicarbonate at Month 6 [Baseline, month 6]
Laboratory chemistry bicarbonate
- Change From Baseline in Bicarbonate at Month 12 [Baseline, Month 12]
Laboratory chemistry bicarbonate
- Change From Baseline in Total Bilirubin at Month 1 [baseline, month 1]
Laboratory chemistry total bilirubin
- Change From Baseline in Total Bilirubin at Month 3 [Baseline, month 3]
Laboratory chemistry total bilirubin
- Change From Baseline in Total Bilirubin at Month 6 [Baseline, month 6]
Laboratory chemistry total bilirubin
- Change From Baseline in Total Bilirubin at Month 12 [Baseline, month 12]
Laboratory chemistry total bilirubin
- Change From Baseline in Blood Urea Nitrogen at Month 1 [Baseline, month 1]
Laboratory chemistry blood urea nitrogen
- Change From Baseline in Blood Urea Nitrogen at Month 3 [Baseline, month 3]
Laboratory chemistry blood urea nitrogen
- Change From Baseline in Blood Urea Nitrogen at Month 6 [Baseline, month 6]
Laboratory chemistry blood urea nitrogen
- Change From Baseline in Blood Urea Nitrogen at Month 12 [baseline, month 12]
Laboratory chemistry blood urea nitrogen
- Change From Baseline in Calcium at Month 1 [baseline. month 1]
Laboratory chemistry calcium
- Change From Baseline in Calcium at Month 3 [Baseline, month 3]
Laboratory chemistry calcium
- Change From Baseline in Calcium at Month 6 [baseline, month 6]
Laboratory chemistry calcium
- Change From Baseline in Calcium at Month 12 [Baseline, month 12]
Laboratory chemistry calcium
- Change From Baseline in Calcium (Corrected) at Month 1 [Baseline, month 1]
Laboratory chemistry albumin-adjusted calcium
- Change From Baseline in Calcium (Corrected) at Month 3 [baseline, month 3]
Laboratory chemistry albumin-adjusted calcium
- Change From Baseline in Calcium (Corrected) at Month 6 [Baseline, Month 6]
Laboratory chemistry albumin-adjusted calcium
- Change From Baseline in Calcium (Corrected) at Month 12 [Baselien, Month 12]
Laboratory chemistry albumin-adjusted calcium
- Change From Baseline in Chloride at Month 1 [baseline, month 1]
Laboratory chemistry chloride
- Change From Baseline in Chloride at Month 3 [Baseline, month 3]
Laboratory chemistry chloride
- Change From Baseline in Chloride at Month 6 [Baseline, month 6]
Laboratory chemistry chloride
- Change From Baseline in Chloride at Month 12 [Baseline, month 12]
Laboratory chemistry chloride
- Change From Baseline in Creatinine at Month 1 [Baseline, month 1]
Laboratory chemistry creatinine
- Change From Baseline in Creatinine at Month 3 [Baseline, month 3]
Laboratory chemistry creatinine
- Change From Baseline in Creatinine at Month 6 [Baseline, month 6]
Laboratory chemistry creatinine
- Change From Baseline in Creatinine at Month 12 [Baseline, month 12]
Laboratory chemistry creatinine
- Change From Baseline in Gamma-Glutamyl Transferase at Month 1 [Baseline, month 1]
Laboratory chemistry gamma-glutamyl transferase
- Change From Baseline in Gamma-Glutamyl Transferase at Month 3 [Baseline, month 3]
Laboratory chemistry gamma-glutamyl transferase
- Change From Baseline in Gamma-Glutamyl Transferase at Month 6 [Baseline, month 6]
Laboratory chemistry gamma-glutamyl transferase
- Change From Baseline in Gamma-Glutamyl Transferase at Month 12 [Baseline, month 12]
Laboratory chemistry gamma-glutamyl transferase
- Change From Baseline in Glucose at Month 1 [Baseline, month 1]
Laboratory chemistry glucose
- Change From Baseline in Glucose at Month 3 [Baseline, month 3]
Laboratory chemistry glucose
- Change From Baseline in Glucose at Month 6 [Baseline, month 6]
Laboratory chemistry glucose
- Change From Baseline in Glucose at Month 12 [baseline, month 12]
Laboratory chemistry glucose
- Change From Baseline in Potassium at Month 1 [Baseline, month 1]
Laboratory chemistry potassium
- Change From Baseline in Potassium at Month 3 [Baseline, month 3]
Laboratory chemistry potassium
- Change From Baseline in Potassium at Month 6 [Baseline, month 6]
Laboratory chemistry potassium
- Change From Baseline in Potassium at Month 12 [Baseline, month 12]
Laboratory chemistry potassium
- Change From Baseline in Magnesium at Month 1 [Baseline, month 1]
Laboratory chemistry magnesium
- Change From Baseline in Magnesium at Month 3 [Baseline, month 3]
Laboratory chemistry magnesium
- Change From Baseline in Magnesium at Month 6 [Baseline, month 6]
Laboratory chemistry magnesium
- Change From Baseline in Magnesium at Month 12 [Baseline, month 12]
Laboratory chemistry magnesium
- Change From Baseline in Sodium at Month 1 [Baseline, month 1]
Laboratory chemistry sodium
- Change From Baseline in Sodium at Month 3 [Baseline, Month 3]
Change From Baseline in Sodium at Month 3
- Change From Baseline in Sodium at Month 6 [Baseline, month 6]
Laboratory chemistry sodium
- Change From Baseline in Sodium at Month 12 [Baseline, month 12]
Laboratory chemistry sodium
- Change From Baseline in Phosphorus at Month 1 [Baseline, month 1]
Laboratory chemistry phosphorus
- Change From Baseline in Phosphorus at Month 3 [Baseline, month 3]
Laboratory chemistry phosphorus
- Change From Baseline in Phosphorus at Month 6 [Baseline, month 6]
Laboratory chemistry phosphorus
- Change From Baseline in Phosphorus at Month 12 [Baseline, month 12]
Change From Baseline in Phosphorus at Month 12
- Change From Baseline in Total Protein at Month 1 [Baseline, month 1]
Laboratory chemistry total protein
- Change From Baseline in Total Protein at Month 3 [Baseline, month 3]
Laboratory chemistry total protein
- Change From Baseline in Total Protein at Month 6 [Baseline, month 6]
Laboratory chemistry total protein
- Change From Baseline in Total Protein at Month 12 [Baseline, month 12]
Laboratory chemistry total protein
- Change From Baseline in Aspartate Amino Transferase at Month 1 [Baseline, month 1]
Laboratory chemistry aspartate amino transferase
- Change From Baseline in Aspartate Amino Transferase at Month 3 [Baseline, month 3]
Laboratory chemistry aspartate amino transferase
- Change From Baseline in Aspartate Amino Transferase [Baseline, month 6]
Laboratory chemistry aspartate amino transferase
- Change From Baseline in Aspartate Amino Transferase at Month 12 [Baseline, month 12]
Laboratory chemistry aspartate amino transferase
- Change From Baseline in Alanine Amino Transferase at Month 1 [Baseline, month 1]
Laboratory chemistry alanine amino transferase
- Change From Baseline in Alanine Amino Transferase at Month 3 [Baseline, month 3]
Laboratory Chemistry alanine amino transferase
- Change From Baseline in Alanine Amino Transferase at Month 6 [Baseline, month 6]
Laboratory chemistry alanine amino transferase
- Change From Baseline in Alanine Amino Transferase at Month 12 [Baseline, month 12]
Laboratory chemistry alanine amino transferase
- Change From Baseline in Basophils at Month 1 [baseline, month 1]
Laboratory hematology basophils
- Change From Baseline in Basophils at Month 3 [Baseline, month 3]
Laboratory hematology basophils
- Change From Baseline in Basophils at Month 6 [Baseline, month 6]
Laboratory hematology basophils
- Change From Baseline in Basophils at Month 12 [Baseline, month 12]
Laboratory hematology basophils
- Change From Baseline in Eosinophils at Month 1 [Baseline, month 1]
Laboratory hematology eosinophils
- Change From Baseline in Eosinophils at Month 3 [Baseline, month 3]
Laboratory hematology eosinophils
- Change From Baseline in Eosinophils at Month 6 [Baseline, month 6]
Laboratory hematology eosinophils
- Change From Baseline in Eosinophils at Month 12 [Baseline, month 12]
Laboratory hematology eosinophils
- Change From Baseline in Hematocrit at Month 1 [Baseline, month 1]
Laboratory hematology hematocrit
- Change From Baseline in Hematocrit at Month 3 [Baseline, month 3]
Laboratory hematology hematocrit
- Change From Baseline in Hematocrit at Month 6 [Baseline, month 6]
Laboratory hematology hematocrit
- Change From Baseline in Hematocrit at Month 12 [Baseline, month 12]
Laboratory hematology hematocrit
- Change From Baseline in Hemoglobin at Month 1 [Baseline, month 1]
Laboratory hematology hemoglobin
- Change From Baseline in Hemoglobin at Month 3 [Baseline, month 3]
Laboratory hematology hemoglobin
- Change From Baseline in Hemoglobin at Month 6 [Baseline, month 6]
Laboratory hematology hemoglobin
- Change From Baseline in Hemoglobin at Month 12 [Baseline, month 12]
Laboratory hematology hemoglobin
- Change From Baseline in Lymphocytes at Month 1 [Baseline, month 1]
Laboratory hematology lymphocytes
- Change From Baseline in Lymphocytes at Month 3 [Baseline, month 3]
Laboratory hematology lymphocytes
- Change From Baseline in Lymphocytes at Month 6 [Baseline, month 6]
Laboratory hematology lymphocytes
- Change From Baseline in Lymphocytes at Month 12 [Baseline, month 12]
Laboratory hematology lymphocytes
- Change From Baseline in Monocytes at Month 1 [Baseline, month 1]
Laboratory hematology monocytes
- Change From Baseline in Monocytes at Month 3 [Baseline, month 3]
Laboratory hematology monocytes
- Change From Baseline in Monocytes at Month 6 [Baseline, month 6]
Laboratory hematology monocytes
- Change From Baseline in Monocytes at Month 12 [Baseline, month 12]
Laboratory hematology monocytes
- Change From Baseline in Total Neutrophils at Month 1 [Baseline, month 1]
Laboratory hematology total neutrophils
- Change From Baseline in Total Neutrophils at Month 3 [Baseline, month 3]
Laboratory hematology total neutrophils
- Change From Baseline in Total Neutrophils at Month 6 [Baseline, month 6]
Laboratory hematology total neutrophils
- Change From Baseline in Total Neutrophils at Month 12 [Baseline, month 12]
Laboratory hematology total neutrophils
- Change From Baseline in Platelets at Month 1 [Baseline, month 1]
Laboratory hematology platelets
- Change From Baseline in Platelets at Month 3 [Baseline, month 3]
Laboratory hematology platelets
- Change From Baseline in Platelets at Month 6 [Baseline, month 6]
Laboratory hematology platelets
- Change From Baseline in Platelets at Month 12 [Baseline, month 12]
Laboratory hematology platelets
- Change From Baseline in Red Blood Cells at Month 1 [Baseline, month 1]
Laboratory hematology red blood cells
- Change From Baseline in Red Blood Cells at Month 3 [Baseline, month 3]
Laboratory hematology red blood cells
- Change From Baseline in Red Blood Cells at Month 6 [Baseline, month 6]
Laboratory hematology red blood cells
- Change From Baseline in Red Blood Cells at Month 12 [Baseline, month 12]
Laboratory hematology red blood cells
- Change From Baseline in White Blood Cells at Month 1 [Baseline, month 1]
Laboratory hematology white blood cells
- Change From Baseline in White Blood Cells at Month 3 [Baseline, month 3]
Laboratpry hematology white blood cells
- Change From Baseline in White Blood Cells at Month 6 [Baseline, month 6]
Laboratory hematology white blood cells
- Change From Baseline in White Blood Cells at Month 12 [Baseline, month 12]
Laboratory hematology white blood cells
- Number of Participants With Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade Greater or Equal to 3 [Month 1, month 3, month 6, month 12]
Participants with laboratory toxicity of grade 3 or 4, graded according to the Common Terminology Criteria for Adverse Events, version 3.0, on the following general guideline: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death related to AE.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of RA.
-
All subjects will be required to have been taking a stable dose of methotrexate.
-
Active RA at screening defined as greater than or equal to 6 swollen joints.
-
The presence of erosive disease
Exclusion Criteria:
-
Received any biologic agent (e.g., Enbrel®, Remicade®, Humira®, Kineret®) or Arava® within 8 weeks before randomization; past use of these agents is allowed.
-
Steroid use greater than 15 mg/day.
-
Scheduled for surgery or joint replacement in the hands, wrists or feet.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- AmgenTrials clinical trials website
- Notice regarding posted summaries of trial results
- To access clinical trial results information click on this link
Publications
- Cohen SB, Dore RK, Lane NE, Ory PA, Peterfy CG, Sharp JT, van der Heijde D, Zhou L, Tsuji W, Newmark R; Denosumab Rheumatoid Arthritis Study Group. Denosumab treatment effects on structural damage, bone mineral density, and bone turnover in rheumatoid arthritis: a twelve-month, multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. Arthritis Rheum. 2008 May;58(5):1299-309. doi: 10.1002/art.23417.
- Deodhar A, Dore RK, Mandel D, Schechtman J, Shergy W, Trapp R, Ory PA, Peterfy CG, Fuerst T, Wang H, Zhou L, Tsuji W, Newmark R. Denosumab-mediated increase in hand bone mineral density associated with decreased progression of bone erosion in rheumatoid arthritis patients. Arthritis Care Res (Hoboken). 2010 Apr;62(4):569-74. doi: 10.1002/acr.20004.
- Dore RK, Cohen SB, Lane NE, Palmer W, Shergy W, Zhou L, Wang H, Tsuji W, Newmark R; Denosumab RA Study Group. Effects of denosumab on bone mineral density and bone turnover in patients with rheumatoid arthritis receiving concurrent glucocorticoids or bisphosphonates. Ann Rheum Dis. 2010 May;69(5):872-5. doi: 10.1136/ard.2009.112920. Epub 2009 Sep 3.
- Sharp JT, Tsuji W, Ory P, Harper-Barek C, Wang H, Newmark R. Denosumab prevents metacarpal shaft cortical bone loss in patients with erosive rheumatoid arthritis. Arthritis Care Res (Hoboken). 2010 Apr;62(4):537-44. doi: 10.1002/acr.20172.
- 20040144
Study Results
Participant Flow
Recruitment Details | First Subject Enrolled: 11-Aug-2004 Last Subject Enrolled: 07-Apr-2005 |
---|---|
Pre-assignment Detail |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Period Title: Overall Study | |||
STARTED | 76 | 73 | 78 |
Received Investigational Product | 72 | 71 | 75 |
COMPLETED | 39 | 38 | 39 |
NOT COMPLETED | 37 | 35 | 39 |
Baseline Characteristics
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo | Total |
---|---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. | Total of all reporting groups |
Overall Participants | 76 | 73 | 78 | 227 |
Age (Years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [Years] |
58
(11)
|
57.3
(11.4)
|
57
(11.1)
|
57.4
(11.2)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
53
69.7%
|
51
69.9%
|
62
79.5%
|
166
73.1%
|
Male |
23
30.3%
|
22
30.1%
|
16
20.5%
|
61
26.9%
|
Race/Ethnicity, Customized (Number) [Number] | ||||
Asian |
1
1.3%
|
1
1.4%
|
2
2.6%
|
4
1.8%
|
Japanese |
1
1.3%
|
0
0%
|
1
1.3%
|
2
0.9%
|
American Indian or Alaska Native |
1
1.3%
|
2
2.7%
|
1
1.3%
|
4
1.8%
|
White or Caucasian |
66
86.8%
|
59
80.8%
|
62
79.5%
|
187
82.4%
|
Black or African American |
1
1.3%
|
3
4.1%
|
2
2.6%
|
6
2.6%
|
Hispanic or Latino |
6
7.9%
|
6
8.2%
|
9
11.5%
|
21
9.3%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
1
1.3%
|
1
0.4%
|
Other |
0
0%
|
2
2.7%
|
0
0%
|
2
0.9%
|
Outcome Measures
Title | Change From Baseline in Rheumatoid Arthritis Erosion Score Measured From MRI Assessments (RA-MRI ES) at Month 6 |
---|---|
Description | Fifteen sites in each wrist and 10 sites in each hand were assessed by a blinded and independent reader. Each site was scored from 0 to 10 (in accordance with the European League Against Rheumatism [EULAR]-Outcome Measures in Rheumatology Clinical Trials convention), with each unit increment representing 10% incremental loss of the peripheral 1 cm of articular bone. The Erosion Score is a sum of erosion scores from 50 joint sites in both hands/wrists and ranges from 0 (normal, no erosion) to 500 (worst possible erosion). |
Time Frame | Baseline, Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 67 | 66 |
Median (Full Range) [units on a scale] |
0.00
(3.49)
|
0.00
(3.43)
|
0.49
(5.08)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.264 |
Comments | ||
Method | van Elteren stratified rank test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.018 |
Comments | ||
Method | van Elteren stratified rank test | |
Comments |
Title | Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 12 |
---|---|
Description | TSS is the sum of erosion and joint space narrowing scores obtained from radiographs of the hands and feet, assessed by 2 independent readers. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The TSS ranged from 0 (normal) to 448 (worst). |
Time Frame | Baseline, Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 69 | 71 |
Median (Inter-Quartile Range) [units on a scale] |
0
|
0
|
0.5
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.032 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.180 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Title | Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 6 |
---|---|
Description | TSS is the sum of erosion and joint space narrowing scores obtained from radiographs of the hands and feet, assessed by 2 independent readers. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The TSS ranged from 0 (normal) to 448 (worst). |
Time Frame | Baseline, Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 69 | 69 | 71 |
Median (Inter-Quartile Range) [units on a scale] |
0
|
0
|
0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.602 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.181 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Title | Change From Baseline in Radiographic Erosion Score at Month 12 |
---|---|
Description | The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet, obtained from radiographs of the hands and feet and assessed by 2 independent readers. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. |
Time Frame | Baseline, Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 69 | 71 |
Median (Inter-Quartile Range) [units on a scale] |
0
|
0
|
0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.012 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.007 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Title | Change From Baseline in Radiographic Erosion Score at Month 6 |
---|---|
Description | The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet, obtained from radiographs of the hands and feet and assessed by 2 independent readers. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. |
Time Frame | Baseline, Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 69 | 69 | 71 |
Median (Inter-Quartile Range) [units on a scale] |
0
|
0
|
0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.277 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.019 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Title | Change From Baseline in Radiographic Joint Space Narrowing Score at Month 12 |
---|---|
Description | Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet obtained from radiographs of the hands and feet and assessed by 2 independent readers. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score (indicating worst joint space narrowing) of 168. |
Time Frame | Baseline, Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 69 | 71 |
Median (Inter-Quartile Range) [units on a scale] |
0
|
0
|
0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.382 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.488 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Title | Change From Baseline in Radiographic Joint Space Narrowing Score at Month 6 |
---|---|
Description | Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet obtained from radiographs of the hands and feet and assessed by 2 independent readers. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score (indicating worst joint space narrowing) of 168. |
Time Frame | Baseline, Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 69 | 69 | 71 |
Median (Inter-Quartile Range) [units on a scale] |
0
|
0
|
0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.236 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.712 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Title | Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 1 |
---|---|
Description | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((month 1 value - baseline value) / baseline value ) x 100. Least squares means are based on a repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic). |
Time Frame | Baseline, Month 1 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 1 month. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 66 | 66 | 66 |
Least Squares Mean (Standard Error) [Percent change from baseline] |
0.25
(0.29)
|
0.59
(0.29)
|
-0.34
(0.29)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.026 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.93 | |
Confidence Interval |
() 95% 0.11 to 1.74 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.155 |
Comments | ||
Method | Repeated measures model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.59 | |
Confidence Interval |
() 95% -0.23 to 1.41 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 6 |
---|---|
Description | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to month 6 calculated using ((month 6 value - baseline value) / baseline value ) x 100. Least squares means are based on a repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic). |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 68 | 69 | 68 |
Least Squares Mean (Standard Error) [Percent change from baseline] |
2.61
(0.38)
|
2.40
(0.37)
|
0.73
(0.38)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.002 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 1.67 | |
Confidence Interval |
() 95% 0.62 to 2.72 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 1.89 | |
Confidence Interval |
() 95% 0.84 to 2.94 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 |
---|---|
Description | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic). |
Time Frame | Baseline, Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 62 | 66 | 62 |
Least Squares Mean (Standard Error) [Percent change from baseline] |
4.09
(0.40)
|
3.00
(0.39)
|
0.80
(0.40)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 2.2 | |
Confidence Interval |
() 95% 1.1 to 3.29 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 3.29 | |
Confidence Interval |
() 95% 2.18 to 4.39 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 1 |
---|---|
Description | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((Month 1 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic). |
Time Frame | Baseline, Month 1 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 1 month. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 65 | 65 |
Least Squares Mean (Standard Error) [Percent change from baseline] |
0.64
(0.38)
|
-0.15
(0.38)
|
-0.16
(0.38)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.986 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.01 | |
Confidence Interval |
() 95% -1.06 to 1.08 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.141 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.8 | |
Confidence Interval |
() 95% -0.27 to 1.86 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 6 |
---|---|
Description | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 6 calculated using ((Month 6 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic). |
Time Frame | Baseline, Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 68 | 68 | 69 |
Least Squares Mean (Standard Error) [Percent change from baseline] |
0.84
(0.37)
|
0.89
(0.37)
|
-0.06
(0.37)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.073 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.95 | |
Confidence Interval |
() 95% -0.09 to 1.99 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.09 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.89 | |
Confidence Interval |
() 95% -0.14 to 1.93 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 12 |
---|---|
Description | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic). |
Time Frame | Baseline, Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 63 | 64 | 63 |
Least Squares Mean (Standard Error) [Percent change from baseline] |
1.51
(0.47)
|
1.34
(0.47)
|
-0.47
(0.47)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.007 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 1.81 | |
Confidence Interval |
() 95% 0.51 to 3.12 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.003 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 1.98 | |
Confidence Interval |
() 95% 0.67 to 3.29 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percent Change From Baseline in Total Hip Bone Mineral Density at Month 1 |
---|---|
Description | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((Month 1 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic). |
Time Frame | Baseline, Month 1 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 1 month. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 65 | 65 |
Least Squares Mean (Standard Error) [Percent change from baseline] |
0.06
(0.22)
|
0.00
(0.22)
|
-0.02
(0.22)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.938 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.02 | |
Confidence Interval |
() 95% -0.58 to 0.63 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.787 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.08 | |
Confidence Interval |
() 95% -0.53 to 0.69 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percent Change From Baseline in Total Hip Bone Mineral Density at Month 6 |
---|---|
Description | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 6 calculated using ((Month 6 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic). |
Time Frame | Baseline, Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 68 | 68 | 69 |
Least Squares Mean (Standard Error) [Percent change from baseline] |
1.12
(0.24)
|
0.95
(0.24)
|
-0.06
(0.24)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.004 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 1 | |
Confidence Interval |
() 95% 0.33 to 1.67 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 1.18 | |
Confidence Interval |
() 95% 0.51 to 1.85 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12 |
---|---|
Description | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic). |
Time Frame | Baseline, Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 63 | 64 | 63 |
Least Squares Mean (Standard Error) [Percent change from baseline] |
1.67
(0.33)
|
1.56
(0.33)
|
-0.38
(0.33)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 1.94 | |
Confidence Interval |
() 95% 1.02 to 2.85 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Repeated Measures Model | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 2.04 | |
Confidence Interval |
() 95% 1.13 to 2.96 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percent Change From Baseline in Serum Collagen C-Telopeptide (CTX) at Month 3 |
---|---|
Description | Percent change from baseline to Month 3 in serum Collagen C-Telopeptide (CTX) Type I calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100. |
Time Frame | Baseline, Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 3 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 70 | 69 | 69 |
Median (Inter-Quartile Range) [Percent change from baseline] |
-78.67
|
-80.46
|
-11.48
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Title | Percent Change From Baseline in Serum CTX at Month 6 |
---|---|
Description | Percent change from baseline to Month 6 in serum Collagen C-Telopeptide (CTX) Type I calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100. |
Time Frame | Baseline, Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 68 | 67 |
Median (Inter-Quartile Range) [Percent change from baseline] |
-62.69
|
-50.64
|
-12.94
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Title | Percent Change From Baseline in Serum CTX at Month 12 |
---|---|
Description | Percent change from Baseline to Month 12 in serum C-Telopeptide (CTX) Type I calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100. |
Time Frame | Baseline, Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 62 | 66 | 62 |
Median (Inter-Quartile Range) [Percent change from baseline] |
-65.65
|
-47.24
|
-23.36
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Title | Percent Change From Baseline in Procollagen 1 N-terminal Peptide (P1NP) at Month 3 |
---|---|
Description | Percent change from baseline to Month 3 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100. |
Time Frame | Baseline, Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 3 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 70 | 69 | 69 |
Median (Inter-Quartile Range) [Percent change from baseline] |
-55.08
|
-57.57
|
-12.23
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Title | Percent Change From Baseline in P1NP at Month 6 |
---|---|
Description | Percent change from baseline to Month 6 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100. |
Time Frame | Baseline, Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 68 | 67 |
Median (Inter-Quartile Range) [Percent change from baseline] |
-57.06
|
-51.57
|
-22.17
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Title | Percent Change From Baseline in P1NP at Month 12 |
---|---|
Description | Percent change from baseline to Month 12 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100. |
Time Frame | Baseline, Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 33 | 39 | 30 |
Median (Inter-Quartile Range) [Percent change from baseline] |
-45.84
|
-41.8
|
-17.53
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.016 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Title | Percent Change From Baseline in Urine Type II Collagen C-telopeptide (C-Tx) /Creatinine at Month 3 |
---|---|
Description | Percent change from baseline to Month 3 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100. |
Time Frame | Baseline, Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 3 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 63 | 63 | 65 |
Median (Inter-Quartile Range) [Percent change from baseline] |
-46.59
|
-35.8
|
2.71
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Title | Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 6 |
---|---|
Description | Percent change from baseline to Month 6 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100. |
Time Frame | Baseline, Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 56 | 63 | 63 |
Median (Inter-Quartile Range) [Percent change from baseline] |
7.17
|
9.65
|
4.54
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.673 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.589 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Title | Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 12 |
---|---|
Description | Percent change from baseline to Month 12 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100. |
Time Frame | Baseline, Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 29 | 35 | 22 |
Median (Inter-Quartile Range) [Percent change from baseline] |
36.92
|
61.92
|
-3.93
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Denosumab 60 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.175 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Denosumab 180 mg, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.133 |
Comments | ||
Method | van Elteren Stratified Rank Test | |
Comments |
Title | Number of Participants With Anti-Denosumab Binding Antibodies |
---|---|
Description | Serum from participants was tested for antibodies to denosumab by immuoassay at months 1, 3, 6 and 12. The number of participants with anti-denosumab antibodies at any assessment is reported. |
Time Frame | Assessed at Baseline and at Months 1, 3, 6 and 12. |
Outcome Measure Data
Analysis Population Description |
---|
Patients who received at least 1 dose of investigational product and with at least one postbaseline sample taken. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 72 | 70 | 75 |
Number [Participants] |
4
5.3%
|
0
0%
|
2
2.6%
|
Title | Number of Participants With Anti-Denosumab Binding Antibody and Neutralizing Antibody |
---|---|
Description | Serum from participants testing positive for anti-denosumab binding antibodies was tested in a cell-based bioassay for neutralizing activity against denosumab. |
Time Frame | Baseline to Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Patients who were positive for anti-denosumab antibodies |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 4 | 0 | 2 |
Number [Participants] |
0
0%
|
0
0%
|
Title | Change From Baseline in Albumin at Month 1 |
---|---|
Description | Laboratory Chemistry Albumin |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 69 | 68 | 71 |
Mean (Standard Deviation) [g/L] |
-0.36
(2.29)
|
-0.24
(2.25)
|
-0.30
(2.21)
|
Title | Change From Baseline in Albumin at Month 3 |
---|---|
Description | Laboratory chemistry albumin |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 70 | 68 | 71 |
Mean (Standard Deviation) [g/L] |
-0.30
(2.18)
|
-0.12
(2.28)
|
-0.18
(2.07)
|
Title | Change From Baseline in Albumin at Month 6 |
---|---|
Description | Laboratory chemistry albumin |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 66 | 68 | 69 |
Mean (Standard Deviation) [g/L] |
-0.30
(2.49)
|
-0.90
(2.56)
|
-0.77
(2.40)
|
Title | Change From Baseline in Albumin at Month 12 |
---|---|
Description | Laboratory chemistry albumin |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 65 | 63 |
Mean (Standard Deviation) [g/L] |
-0.13
(2.41)
|
-0.06
(2.26)
|
-0.59
(2.49)
|
Title | Change From Baseline in Alkaline Phosphatase at Month 1 |
---|---|
Description | Laboratory chemistry alkaline phoshatatse |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 70 | 68 | 72 |
Mean (Standard Deviation) [U/L] |
-5.87
(10.52)
|
-3.66
(11.97)
|
1.18
(15.62)
|
Title | Change From Baseline in Alkaline Phosphatase at Month 3 |
---|---|
Description | Laboratory chemisrty alkaline phosphatase |
Time Frame | baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 71 | 68 | 72 |
Mean (Standard Deviation) [U/L] |
-13.27
(15.91)
|
-12.38
(13.09)
|
-2.03
(8.37)
|
Title | Change From Baseline in Alkaline Phosphatase at Month 6 |
---|---|
Description | Laboratory chemistry alkaline phosphatase |
Time Frame | baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 68 | 70 |
Mean (Standard Deviation) [U/L] |
-7.84
(31.94)
|
-12.49
(12.61)
|
-0.54
(18.46)
|
Title | Change From Baseline in Alkaline Phosphatase at Month 12 |
---|---|
Description | Laboratory chemistry alkaline phosphatase |
Time Frame | baseine, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 65 | 64 |
Mean (Standard Deviation) [U/L] |
-11.92
(16.74)
|
-11.34
(18.18)
|
-4.63
(16.70)
|
Title | Change From Baseline in Bicarbonate at Month 1 |
---|---|
Description | Laboratory chemistry bicarbonate |
Time Frame | baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 67 | 70 |
Mean (Standard Deviation) [mmol/L] |
0.78
(2.31)
|
0.06
(3.06)
|
0.54
(2.94)
|
Title | Change From Baseline in Bicarbonate at Month 3 |
---|---|
Description | Laboratory chemistry bicarbonate |
Time Frame | baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 69 | 67 | 70 |
Mean (Standard Deviation) [mmol/L] |
0.12
(2.40)
|
0.39
(2.84)
|
-0.67
(3.17)
|
Title | Change From Baseline in Bicarbonate at Month 6 |
---|---|
Description | Laboratory chemistry bicarbonate |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 67 | 66 |
Mean (Standard Deviation) [mmol/L] |
0.45
(2.29)
|
-0.12
(2.61)
|
-0.18
(2.67)
|
Title | Change From Baseline in Bicarbonate at Month 12 |
---|---|
Description | Laboratory chemistry bicarbonate |
Time Frame | Baseline, Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 63 | 64 | 62 |
Mean (Standard Deviation) [mmol/L] |
0.81
(2.12)
|
0.58
(2.68)
|
0.23
(2.50)
|
Title | Change From Baseline in Total Bilirubin at Month 1 |
---|---|
Description | Laboratory chemistry total bilirubin |
Time Frame | baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 67 | 70 |
Mean (Standard Deviation) [umol/L] |
0.26
(2.39)
|
-0.23
(2.45)
|
0.42
(2.83)
|
Title | Change From Baseline in Total Bilirubin at Month 3 |
---|---|
Description | Laboratory chemistry total bilirubin |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 69 | 67 | 70 |
Mean (Standard Deviation) [umol/L] |
0.92
(2.17)
|
-0.23
(2.36)
|
0.44
(2.74)
|
Title | Change From Baseline in Total Bilirubin at Month 6 |
---|---|
Description | Laboratory chemistry total bilirubin |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 67 | 66 |
Mean (Standard Deviation) [umol/L] |
1.08
(2.58)
|
-0.61
(2.49)
|
0.34
(3.30)
|
Title | Change From Baseline in Total Bilirubin at Month 12 |
---|---|
Description | Laboratory chemistry total bilirubin |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 63 | 64 | 62 |
Mean (Standard Deviation) [umol/L] |
0.41
(2.58)
|
-0.35
(2.28)
|
0.03
(2.80)
|
Title | Change From Baseline in Blood Urea Nitrogen at Month 1 |
---|---|
Description | Laboratory chemistry blood urea nitrogen |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 70 | 68 | 72 |
Mean (Standard Deviation) [mmol/L] |
0
(1.35)
|
0.15
(1.40)
|
-0.01
(1.55)
|
Title | Change From Baseline in Blood Urea Nitrogen at Month 3 |
---|---|
Description | Laboratory chemistry blood urea nitrogen |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 71 | 68 | 72 |
Mean (Standard Deviation) [mmol/L] |
0.04
(1.35)
|
0.41
(1.59)
|
0.06
(1.43)
|
Title | Change From Baseline in Blood Urea Nitrogen at Month 6 |
---|---|
Description | Laboratory chemistry blood urea nitrogen |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 68 | 70 |
Mean (Standard Deviation) [mmol/L] |
-0.21
(1.44)
|
-0.08
(1.41)
|
-0.04
(2.29)
|
Title | Change From Baseline in Blood Urea Nitrogen at Month 12 |
---|---|
Description | Laboratory chemistry blood urea nitrogen |
Time Frame | baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 65 | 64 |
Mean (Standard Deviation) [mmol/L] |
0.32
(1.37)
|
0.24
(1.46)
|
-0.09
(1.56)
|
Title | Change From Baseline in Calcium at Month 1 |
---|---|
Description | Laboratory chemistry calcium |
Time Frame | baseline. month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 70 | 68 | 72 |
Mean (Standard Deviation) [mmol/L] |
-0.05
(0.11)
|
-0.05
(0.09)
|
0.01
(0.09)
|
Title | Change From Baseline in Calcium at Month 3 |
---|---|
Description | Laboratory chemistry calcium |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 71 | 68 | 72 |
Mean (Standard Deviation) [mmol/L] |
-0.01
(0.11)
|
-0.02
(0.10)
|
0
(0.10)
|
Title | Change From Baseline in Calcium at Month 6 |
---|---|
Description | Laboratory chemistry calcium |
Time Frame | baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 68 | 70 |
Mean (Standard Deviation) [mmol/L] |
-0.01
(0.10)
|
-0.03
(0.11)
|
-0.01
(0.10)
|
Title | Change From Baseline in Calcium at Month 12 |
---|---|
Description | Laboratory chemistry calcium |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 65 | 64 |
Mean (Standard Deviation) [mmol/L] |
-0.01
(0.11)
|
0.01
(0.09)
|
0.01
(0.08)
|
Title | Change From Baseline in Calcium (Corrected) at Month 1 |
---|---|
Description | Laboratory chemistry albumin-adjusted calcium |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 70 | 68 | 72 |
Mean (Standard Deviation) [mmol/L] |
-0.05
(0.11)
|
-0.05
(0.09)
|
0.01
(0.09)
|
Title | Change From Baseline in Calcium (Corrected) at Month 3 |
---|---|
Description | Laboratory chemistry albumin-adjusted calcium |
Time Frame | baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 71 | 68 | 72 |
Mean (Standard Deviation) [mmol/L] |
-0.01
(0.11)
|
-0.02
(0.09)
|
0
(0.10)
|
Title | Change From Baseline in Calcium (Corrected) at Month 6 |
---|---|
Description | Laboratory chemistry albumin-adjusted calcium |
Time Frame | Baseline, Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 68 | 70 |
Mean (Standard Deviation) [mmol/L] |
-0.01
(0.10)
|
-0.02
(0.10)
|
-0.01
(0.09)
|
Title | Change From Baseline in Calcium (Corrected) at Month 12 |
---|---|
Description | Laboratory chemistry albumin-adjusted calcium |
Time Frame | Baselien, Month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 65 | 64 |
Mean (Standard Deviation) [mmol/L] |
-0.01
(0.11)
|
0.01
(0.09)
|
0
(0.08)
|
Title | Change From Baseline in Chloride at Month 1 |
---|---|
Description | Laboratory chemistry chloride |
Time Frame | baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 70 | 69 | 72 |
Mean (Standard Deviation) [mmol/L] |
0.24
(2.36)
|
0.58
(2.66)
|
0.01
(2.09)
|
Title | Change From Baseline in Chloride at Month 3 |
---|---|
Description | Laboratory chemistry chloride |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 71 | 69 | 72 |
Mean (Standard Deviation) [mmol/L] |
-0.01
(2.67)
|
0.38
(2.35)
|
0.78
(2.20)
|
Title | Change From Baseline in Chloride at Month 6 |
---|---|
Description | Laboratory chemistry chloride |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 69 | 70 |
Mean (Standard Deviation) [mmol/L] |
-0.57
(2.85)
|
0.48
(2.19)
|
0
(2.79)
|
Title | Change From Baseline in Chloride at Month 12 |
---|---|
Description | Laboratory chemistry chloride |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 66 | 64 |
Mean (Standard Deviation) [mmol/L] |
-0.62
(2.45)
|
-0.21
(2.58)
|
-0.08
(2.39)
|
Title | Change From Baseline in Creatinine at Month 1 |
---|---|
Description | Laboratory chemistry creatinine |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 70 | 69 | 72 |
Mean (Standard Deviation) [µmol/L] |
-0.88
(9.89)
|
0.38
(8.63)
|
1.47
(8.78)
|
Title | Change From Baseline in Creatinine at Month 3 |
---|---|
Description | Laboratory chemistry creatinine |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 71 | 69 | 72 |
Mean (Standard Deviation) [µmol/L] |
0.62
(11.11)
|
3.20
(8.30)
|
3.81
(9.24)
|
Title | Change From Baseline in Creatinine at Month 6 |
---|---|
Description | Laboratory chemistry creatinine |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 69 | 70 |
Mean (Standard Deviation) [µmol/L] |
3.30
(10.97)
|
3.84
(9.88)
|
3.54
(11.60)
|
Title | Change From Baseline in Creatinine at Month 12 |
---|---|
Description | Laboratory chemistry creatinine |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 66 | 64 |
Mean (Standard Deviation) [µmol/L] |
5.44
(10.09)
|
4.42
(9.59)
|
3.73
(7.84)
|
Title | Change From Baseline in Gamma-Glutamyl Transferase at Month 1 |
---|---|
Description | Laboratory chemistry gamma-glutamyl transferase |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 70 | 68 | 72 |
Mean (Standard Deviation) [U/L] |
1.04
(8.13)
|
-1.25
(9.67)
|
0.26
(10.63)
|
Title | Change From Baseline in Gamma-Glutamyl Transferase at Month 3 |
---|---|
Description | Laboratory chemistry gamma-glutamyl transferase |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 71 | 68 | 72 |
Mean (Standard Deviation) [U/L] |
2.32
(10.94)
|
0.04
(9.90)
|
1.51
(15.87)
|
Title | Change From Baseline in Gamma-Glutamyl Transferase at Month 6 |
---|---|
Description | Laboratory chemistry gamma-glutamyl transferase |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 68 | 70 |
Mean (Standard Deviation) [U/L] |
7.37
(36.42)
|
0.28
(12.70)
|
5.67
(37.98)
|
Title | Change From Baseline in Gamma-Glutamyl Transferase at Month 12 |
---|---|
Description | Laboratory chemistry gamma-glutamyl transferase |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 65 | 64 |
Mean (Standard Deviation) [U/L] |
2.98
(10.94)
|
1.08
(16.09)
|
-1.38
(14.70)
|
Title | Change From Baseline in Glucose at Month 1 |
---|---|
Description | Laboratory chemistry glucose |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 69 | 68 | 71 |
Mean (Standard Deviation) [mmol/L] |
0.06
(0.76)
|
0.20
(0.65)
|
0.05
(1.28)
|
Title | Change From Baseline in Glucose at Month 3 |
---|---|
Description | Laboratory chemistry glucose |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 70 | 68 | 71 |
Mean (Standard Deviation) [mmol/L] |
0.08
(0.87)
|
0.20
(0.63)
|
0.04
(1.26)
|
Title | Change From Baseline in Glucose at Month 6 |
---|---|
Description | Laboratory chemistry glucose |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 66 | 68 | 69 |
Mean (Standard Deviation) [mmol/L] |
0.12
(0.85)
|
0.20
(0.65)
|
-0.05
(1.26)
|
Title | Change From Baseline in Glucose at Month 12 |
---|---|
Description | Laboratory chemistry glucose |
Time Frame | baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 65 | 63 |
Mean (Standard Deviation) [mmol/L] |
-0.04
(0.66)
|
0.22
(0.96)
|
0.19
(1.27)
|
Title | Change From Baseline in Potassium at Month 1 |
---|---|
Description | Laboratory chemistry potassium |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 70 | 69 | 72 |
Mean (Standard Deviation) [mmol/L] |
0.06
(0.38)
|
0.06
(0.36)
|
0.04
(0.36)
|
Title | Change From Baseline in Potassium at Month 3 |
---|---|
Description | Laboratory chemistry potassium |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 71 | 69 | 72 |
Mean (Standard Deviation) [mmol/L] |
-0.01
(0.39)
|
0.06
(0.40)
|
0.04
(0.38)
|
Title | Change From Baseline in Potassium at Month 6 |
---|---|
Description | Laboratory chemistry potassium |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 69 | 70 |
Mean (Standard Deviation) [mmol/L] |
0.01
(0.44)
|
-0.01
(0.36)
|
0
(0.42)
|
Title | Change From Baseline in Potassium at Month 12 |
---|---|
Description | Laboratory chemistry potassium |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 66 | 64 |
Mean (Standard Deviation) [mmol/L] |
-0.07
(0.44)
|
-0.08
(0.35)
|
-0.04
(0.43)
|
Title | Change From Baseline in Magnesium at Month 1 |
---|---|
Description | Laboratory chemistry magnesium |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 70 | 68 | 72 |
Mean (Standard Deviation) [mmol/L] |
0.01
(0.06)
|
0.02
(0.06)
|
0.01
(0.05)
|
Title | Change From Baseline in Magnesium at Month 3 |
---|---|
Description | Laboratory chemistry magnesium |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 71 | 68 | 72 |
Mean (Standard Deviation) [mmol/L] |
-0.01
(0.06)
|
0.02
(0.06)
|
0
(0.06)
|
Title | Change From Baseline in Magnesium at Month 6 |
---|---|
Description | Laboratory chemistry magnesium |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 68 | 70 |
Mean (Standard Deviation) [mmol/L] |
0
(0.06)
|
0.01
(0.06)
|
0.01
(0.07)
|
Title | Change From Baseline in Magnesium at Month 12 |
---|---|
Description | Laboratory chemistry magnesium |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 65 | 64 |
Mean (Standard Deviation) [mmol/L] |
-0.01
(0.06)
|
-0.01
(0.07)
|
-0.01
(0.08)
|
Title | Change From Baseline in Sodium at Month 1 |
---|---|
Description | Laboratory chemistry sodium |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 70 | 69 | 72 |
Mean (Standard Deviation) [mmol/L] |
-0.03
(1.93)
|
-0.06
(2.62)
|
0.33
(2.03)
|
Title | Change From Baseline in Sodium at Month 3 |
---|---|
Description | Change From Baseline in Sodium at Month 3 |
Time Frame | Baseline, Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 71 | 69 | 72 |
Mean (Standard Deviation) [mmol/L] |
-0.14
(2.13)
|
-0.16
(2.29)
|
0.39
(2.38)
|
Title | Change From Baseline in Sodium at Month 6 |
---|---|
Description | Laboratory chemistry sodium |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 69 | 70 |
Mean (Standard Deviation) [mmol/L] |
-0.12
(1.98)
|
-0.06
(1.75)
|
0.03
(2.27)
|
Title | Change From Baseline in Sodium at Month 12 |
---|---|
Description | Laboratory chemistry sodium |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 66 | 64 |
Mean (Standard Deviation) [mmol/L] |
-0.25
(2.02)
|
-0.27
(2.75)
|
0.33
(2.38)
|
Title | Change From Baseline in Phosphorus at Month 1 |
---|---|
Description | Laboratory chemistry phosphorus |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 68 | 68 | 71 |
Mean (Standard Deviation) [mmol/L] |
-0.09
(0.16)
|
-0.06
(0.19)
|
0.02
(0.14)
|
Title | Change From Baseline in Phosphorus at Month 3 |
---|---|
Description | Laboratory chemistry phosphorus |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 69 | 68 | 71 |
Mean (Standard Deviation) [mmol/L] |
-0.03
(0.16)
|
-0.03
(0.18)
|
0.01
(0.20)
|
Title | Change From Baseline in Phosphorus at Month 6 |
---|---|
Description | Laboratory chemistry phosphorus |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 68 | 68 |
Mean (Standard Deviation) [mmol/L] |
-0.05
(0.17)
|
-0.01
(0.18)
|
0.03
(0.19)
|
Title | Change From Baseline in Phosphorus at Month 12 |
---|---|
Description | Change From Baseline in Phosphorus at Month 12 |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 63 | 65 | 63 |
Mean (Standard Deviation) [mmol/L] |
-0.05
(0.17)
|
0
(0.17)
|
0
(0.16)
|
Title | Change From Baseline in Total Protein at Month 1 |
---|---|
Description | Laboratory chemistry total protein |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 69 | 68 | 71 |
Mean (Standard Deviation) [g/L] |
-0.46
(3.56)
|
-0.40
(3.22)
|
0.21
(3.00)
|
Title | Change From Baseline in Total Protein at Month 3 |
---|---|
Description | Laboratory chemistry total protein |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 70 | 68 | 71 |
Mean (Standard Deviation) [g/L] |
-0.29
(3.35)
|
0.07
(3.42)
|
-0.20
(3.54)
|
Title | Change From Baseline in Total Protein at Month 6 |
---|---|
Description | Laboratory chemistry total protein |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 66 | 68 | 69 |
Mean (Standard Deviation) [g/L] |
-0.09
(4.13)
|
-0.62
(3.40)
|
-0.57
(3.19)
|
Title | Change From Baseline in Total Protein at Month 12 |
---|---|
Description | Laboratory chemistry total protein |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 65 | 63 |
Mean (Standard Deviation) [g/L] |
-0.97
(3.76)
|
-0.91
(3.55)
|
-0.98
(3.10)
|
Title | Change From Baseline in Aspartate Amino Transferase at Month 1 |
---|---|
Description | Laboratory chemistry aspartate amino transferase |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 68 | 68 | 71 |
Mean (Standard Deviation) [U/L] |
-0.79
(5.84)
|
-0.26
(8.14)
|
0.90
(8.35)
|
Title | Change From Baseline in Aspartate Amino Transferase at Month 3 |
---|---|
Description | Laboratory chemistry aspartate amino transferase |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 69 | 68 | 71 |
Mean (Standard Deviation) [U/L] |
1.99
(5.77)
|
0.40
(8.78)
|
2.69
(9.37)
|
Title | Change From Baseline in Aspartate Amino Transferase |
---|---|
Description | Laboratory chemistry aspartate amino transferase |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 68 | 68 |
Mean (Standard Deviation) [U/L] |
3.85
(15.66)
|
0.87
(7.58)
|
3.24
(15.90)
|
Title | Change From Baseline in Aspartate Amino Transferase at Month 12 |
---|---|
Description | Laboratory chemistry aspartate amino transferase |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 63 | 65 | 63 |
Mean (Standard Deviation) [U/L] |
3.86
(18.62)
|
3.75
(18.11)
|
2.24
(7.32)
|
Title | Change From Baseline in Alanine Amino Transferase at Month 1 |
---|---|
Description | Laboratory chemistry alanine amino transferase |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 67 | 70 |
Mean (Standard Deviation) [U/L] |
-1.84
(8.61)
|
-1.03
(12.37)
|
1.20
(15.44)
|
Title | Change From Baseline in Alanine Amino Transferase at Month 3 |
---|---|
Description | Laboratory Chemistry alanine amino transferase |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 69 | 67 | 70 |
Mean (Standard Deviation) [U/L] |
0.04
(8.85)
|
-2.10
(14.34)
|
1.54
(13.00)
|
Title | Change From Baseline in Alanine Amino Transferase at Month 6 |
---|---|
Description | Laboratory chemistry alanine amino transferase |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 65 | 67 | 66 |
Mean (Standard Deviation) [U/L] |
1.20
(15.83)
|
-1.76
(14.12)
|
5.44
(51.19)
|
Title | Change From Baseline in Alanine Amino Transferase at Month 12 |
---|---|
Description | Laboratory chemistry alanine amino transferase |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 63 | 64 | 62 |
Mean (Standard Deviation) [U/L] |
4.86
(24.46)
|
1.66
(14.30)
|
1.82
(14.41)
|
Title | Change From Baseline in Basophils at Month 1 |
---|---|
Description | Laboratory hematology basophils |
Time Frame | baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 66 | 64 | 69 |
Mean (Standard Deviation) [*10^9/L] |
0
(0.07)
|
0
(0.07)
|
-0.01
(0.07)
|
Title | Change From Baseline in Basophils at Month 3 |
---|---|
Description | Laboratory hematology basophils |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 64 | 67 |
Mean (Standard Deviation) [* 10^9/L] |
-0.01
(0.06)
|
-0.01
(0.07)
|
-0.01
(0.07)
|
Title | Change From Baseline in Basophils at Month 6 |
---|---|
Description | Laboratory hematology basophils |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 65 | 66 |
Mean (Standard Deviation) [* 10^9/L] |
0
(0.06)
|
0
(0.07)
|
0
(0.06)
|
Title | Change From Baseline in Basophils at Month 12 |
---|---|
Description | Laboratory hematology basophils |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 61 | 62 | 60 |
Mean (Standard Deviation) [* 10^9/L] |
0.02
(0.09)
|
0
(0.09)
|
0.03
(0.07)
|
Title | Change From Baseline in Eosinophils at Month 1 |
---|---|
Description | Laboratory hematology eosinophils |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 66 | 64 | 69 |
Mean (Standard Deviation) [* 10^9/L] |
-0.02
(0.09)
|
-0.01
(0.09)
|
0.01
(0.08)
|
Title | Change From Baseline in Eosinophils at Month 3 |
---|---|
Description | Laboratory hematology eosinophils |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 64 | 67 |
Mean (Standard Deviation) [* 10^9/L] |
0
(0.10)
|
0
(0.10)
|
-0.01
(0.09)
|
Title | Change From Baseline in Eosinophils at Month 6 |
---|---|
Description | Laboratory hematology eosinophils |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 65 | 66 |
Mean (Standard Deviation) [* 10^9/L] |
-0.03
(0.09)
|
0
(0.13)
|
0
(0.13)
|
Title | Change From Baseline in Eosinophils at Month 12 |
---|---|
Description | Laboratory hematology eosinophils |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 61 | 62 | 60 |
Mean (Standard Deviation) [* 10^9/L] |
0.03
(0.16)
|
0.02
(0.12)
|
0.01
(0.12)
|
Title | Change From Baseline in Hematocrit at Month 1 |
---|---|
Description | Laboratory hematology hematocrit |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 66 | 64 | 70 |
Mean (Standard Deviation) [Proportion of red blood cells in blood] |
0
(0.02)
|
0
(0.02)
|
0
(0.02)
|
Title | Change From Baseline in Hematocrit at Month 3 |
---|---|
Description | Laboratory hematology hematocrit |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 68 | 64 | 70 |
Mean (Standard Deviation) [Proportion of red blood cells in blood] |
0.01
(0.02)
|
0
(0.03)
|
0
(0.03)
|
Title | Change From Baseline in Hematocrit at Month 6 |
---|---|
Description | Laboratory hematology hematocrit |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 65 | 67 |
Mean (Standard Deviation) [Proportion of red blood cells in blood] |
0.01
(0.02)
|
0
(0.03)
|
0
(0.03)
|
Title | Change From Baseline in Hematocrit at Month 12 |
---|---|
Description | Laboratory hematology hematocrit |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 61 | 62 | 61 |
Mean (Standard Deviation) [Proportion of red blood cells in blood] |
0
(0.02)
|
0
(0.03)
|
-0.01
(0.03)
|
Title | Change From Baseline in Hemoglobin at Month 1 |
---|---|
Description | Laboratory hematology hemoglobin |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 66 | 64 | 70 |
Mean (Standard Deviation) [g/L] |
-0.33
(6.73)
|
-1.48
(6.39)
|
-0.69
(6.34)
|
Title | Change From Baseline in Hemoglobin at Month 3 |
---|---|
Description | Laboratory hematology hemoglobin |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 68 | 64 | 70 |
Mean (Standard Deviation) [g/L] |
0.69
(7.02)
|
-1.02
(8.36)
|
-1.10
(6.30)
|
Title | Change From Baseline in Hemoglobin at Month 6 |
---|---|
Description | Laboratory hematology hemoglobin |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 65 | 67 |
Mean (Standard Deviation) [g/L] |
-0.36
(7.80)
|
-1.69
(8.82)
|
-0.69
(8.21)
|
Title | Change From Baseline in Hemoglobin at Month 12 |
---|---|
Description | Laboratory hematology hemoglobin |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 61 | 62 | 61 |
Mean (Standard Deviation) [g/L] |
1.21
(9.26)
|
0.02
(11.66)
|
-0.46
(10.08)
|
Title | Change From Baseline in Lymphocytes at Month 1 |
---|---|
Description | Laboratory hematology lymphocytes |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 66 | 64 | 69 |
Mean (Standard Deviation) [* 10^9/L] |
-0.02
(0.41)
|
0.10
(0.40)
|
0
(0.45)
|
Title | Change From Baseline in Lymphocytes at Month 3 |
---|---|
Description | Laboratory hematology lymphocytes |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 64 | 67 |
Mean (Standard Deviation) [* 10^9/L] |
0.07
(0.38)
|
0.14
(0.48)
|
0.08
(0.46)
|
Title | Change From Baseline in Lymphocytes at Month 6 |
---|---|
Description | Laboratory hematology lymphocytes |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 65 | 66 |
Mean (Standard Deviation) [* 10^9/L] |
0.12
(0.41)
|
0.05
(0.35)
|
0.03
(0.68)
|
Title | Change From Baseline in Lymphocytes at Month 12 |
---|---|
Description | Laboratory hematology lymphocytes |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 61 | 62 | 60 |
Mean (Standard Deviation) [* 10^9/L] |
-0.02
(0.49)
|
0.04
(0.50)
|
-0.02
(0.49)
|
Title | Change From Baseline in Monocytes at Month 1 |
---|---|
Description | Laboratory hematology monocytes |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 66 | 64 | 69 |
Mean (Standard Deviation) [* 10^9/L] |
0.01
(0.13)
|
-0.01
(0.10)
|
0.01
(0.12)
|
Title | Change From Baseline in Monocytes at Month 3 |
---|---|
Description | Laboratory hematology monocytes |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 64 | 67 |
Mean (Standard Deviation) [* 10^9/L] |
0.02
(0.11)
|
0.01
(0.11)
|
0.02
(0.11)
|
Title | Change From Baseline in Monocytes at Month 6 |
---|---|
Description | Laboratory hematology monocytes |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 65 | 66 |
Mean (Standard Deviation) [* 10^9/L] |
0.05
(0.17)
|
0.04
(0.12)
|
0.04
(0.13)
|
Title | Change From Baseline in Monocytes at Month 12 |
---|---|
Description | Laboratory hematology monocytes |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 61 | 62 | 60 |
Mean (Standard Deviation) [* 10^9/L] |
0.03
(0.15)
|
0
(0.11)
|
0.02
(0.13)
|
Title | Change From Baseline in Total Neutrophils at Month 1 |
---|---|
Description | Laboratory hematology total neutrophils |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 66 | 64 | 69 |
Mean (Standard Deviation) [* 10^9/L] |
0
(1.97)
|
0.18
(1.99)
|
-0.13
(1.68)
|
Title | Change From Baseline in Total Neutrophils at Month 3 |
---|---|
Description | Laboratory hematology total neutrophils |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 64 | 67 |
Mean (Standard Deviation) [* 10^9/L] |
0.11
(1.92)
|
0.26
(1.64)
|
-0.11
(1.55)
|
Title | Change From Baseline in Total Neutrophils at Month 6 |
---|---|
Description | Laboratory hematology total neutrophils |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 65 | 66 |
Mean (Standard Deviation) [* 10^9/L] |
0.18
(1.67)
|
-0.05
(1.66)
|
0.27
(2.36)
|
Title | Change From Baseline in Total Neutrophils at Month 12 |
---|---|
Description | Laboratory hematology total neutrophils |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 61 | 62 | 60 |
Mean (Standard Deviation) [* 10^9/L] |
0.65
(2.37)
|
0.04
(1.79)
|
0.10
(2.31)
|
Title | Change From Baseline in Platelets at Month 1 |
---|---|
Description | Laboratory hematology platelets |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 64 | 68 |
Mean (Standard Deviation) [* 10^9/L] |
1.78
(44.53)
|
10.36
(49.34)
|
2.96
(44.15)
|
Title | Change From Baseline in Platelets at Month 3 |
---|---|
Description | Laboratory hematology platelets |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 67 | 63 | 69 |
Mean (Standard Deviation) [* 10^9/L] |
-2.82
(48.86)
|
6.86
(50.18)
|
-1.97
(45.94)
|
Title | Change From Baseline in Platelets at Month 6 |
---|---|
Description | Laboratory hematology platelets |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 62 | 65 | 65 |
Mean (Standard Deviation) [* 10^9/L] |
1.95
(54.95)
|
1.00
(45.64)
|
1.57
(53.39)
|
Title | Change From Baseline in Platelets at Month 12 |
---|---|
Description | Laboratory hematology platelets |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 60 | 62 | 59 |
Mean (Standard Deviation) [* 10^9/L] |
3.32
(51.66)
|
-4.26
(51.12)
|
1.07
(58.16)
|
Title | Change From Baseline in Red Blood Cells at Month 1 |
---|---|
Description | Laboratory hematology red blood cells |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 66 | 64 | 70 |
Mean (Standard Deviation) [* 10^9/L] |
-0.01
(0.21)
|
-0.01
(0.20)
|
-0.01
(0.19)
|
Title | Change From Baseline in Red Blood Cells at Month 3 |
---|---|
Description | Laboratory hematology red blood cells |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 68 | 64 | 70 |
Mean (Standard Deviation) [* 10^9/L] |
0.05
(0.23)
|
0.02
(0.28)
|
0
(0.23)
|
Title | Change From Baseline in Red Blood Cells at Month 6 |
---|---|
Description | Laboratory hematology red blood cells |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 65 | 67 |
Mean (Standard Deviation) [* 10^9/L] |
0.01
(0.24)
|
-0.04
(0.26)
|
0.01
(0.26)
|
Title | Change From Baseline in Red Blood Cells at Month 12 |
---|---|
Description | Laboratory hematology red blood cells |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 61 | 62 | 61 |
Mean (Standard Deviation) [* 10^9/L] |
0.01
(0.27)
|
-0.06
(0.30)
|
-0.03
(0.29)
|
Title | Change From Baseline in White Blood Cells at Month 1 |
---|---|
Description | Laboratory hematology white blood cells |
Time Frame | Baseline, month 1 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 66 | 64 | 70 |
Mean (Standard Deviation) [* 10^9/L] |
-0.03
(2.07)
|
0.26
(2.04)
|
-0.10
(1.88)
|
Title | Change From Baseline in White Blood Cells at Month 3 |
---|---|
Description | Laboratpry hematology white blood cells |
Time Frame | Baseline, month 3 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 68 | 64 | 70 |
Mean (Standard Deviation) [* 10^9/L] |
0.18
(1.93)
|
0.40
(1.71)
|
-0.05
(1.64)
|
Title | Change From Baseline in White Blood Cells at Month 6 |
---|---|
Description | Laboratory hematology white blood cells |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 64 | 65 | 67 |
Mean (Standard Deviation) [* 10^9/L] |
0.30
(1.78)
|
0.04
(1.85)
|
0.35
(2.34)
|
Title | Change From Baseline in White Blood Cells at Month 12 |
---|---|
Description | Laboratory hematology white blood cells |
Time Frame | Baseline, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 61 | 62 | 61 |
Mean (Standard Deviation) [* 10^9/L] |
0.70
(2.40)
|
0.11
(1.86)
|
0.13
(2.22)
|
Title | Number of Participants With Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade Greater or Equal to 3 |
---|---|
Description | Participants with laboratory toxicity of grade 3 or 4, graded according to the Common Terminology Criteria for Adverse Events, version 3.0, on the following general guideline: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death related to AE. |
Time Frame | Month 1, month 3, month 6, month 12 |
Outcome Measure Data
Analysis Population Description |
---|
Patients who received at least 1 dose of investigational product. |
Arm/Group Title | Denosumab 180 mg | Denosumab 60 mg | Placebo |
---|---|---|---|
Arm/Group Description | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received placebo subcutaneous injections on Day 1 and at Month 6. |
Measure Participants | 72 | 71 | 75 |
Alanine Amino Transferase-above normal (grade 3) |
0
0%
|
0
0%
|
1
1.3%
|
Aspartate Amino Transferase-above normal (grade 3) |
0
0%
|
1
1.4%
|
0
0%
|
Glucose-above normal (grade 3) |
1
1.3%
|
0
0%
|
0
0%
|
Lymphocytes-below normal (grade 3) |
1
1.3%
|
3
4.1%
|
2
2.6%
|
Sodium-below normal (grade 3) |
1
1.3%
|
2
2.7%
|
0
0%
|
White Blood Cells-below normal (grade 3) |
0
0%
|
1
1.4%
|
1
1.3%
|
Adverse Events
Time Frame | 12 months | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. | |||||
Arm/Group Title | Placebo | Denosumab 60 mg | Denosumab 180 mg | |||
Arm/Group Description | Participants received placebo subcutaneous injections on Day 1 and at Month 6. | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. | |||
All Cause Mortality |
||||||
Placebo | Denosumab 60 mg | Denosumab 180 mg | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
Placebo | Denosumab 60 mg | Denosumab 180 mg | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 5/75 (6.7%) | 3/71 (4.2%) | 6/72 (8.3%) | |||
Blood and lymphatic system disorders | ||||||
Anaemia | 0/75 (0%) | 0/71 (0%) | 1/72 (1.4%) | |||
Cardiac disorders | ||||||
Coronary artery disease | 0/75 (0%) | 0/71 (0%) | 1/72 (1.4%) | |||
Myocardial infarction | 0/75 (0%) | 1/71 (1.4%) | 0/72 (0%) | |||
Gastrointestinal disorders | ||||||
Diabetic gastroparesis | 1/75 (1.3%) | 0/71 (0%) | 0/72 (0%) | |||
Nausea | 1/75 (1.3%) | 0/71 (0%) | 0/72 (0%) | |||
Vomiting | 1/75 (1.3%) | 0/71 (0%) | 0/72 (0%) | |||
Infections and infestations | ||||||
Cellulitis | 0/75 (0%) | 1/71 (1.4%) | 0/72 (0%) | |||
Pyelonephritis | 0/75 (0%) | 0/71 (0%) | 1/72 (1.4%) | |||
Urosepsis | 0/75 (0%) | 0/71 (0%) | 1/72 (1.4%) | |||
Injury, poisoning and procedural complications | ||||||
Humerus fracture | 0/75 (0%) | 1/71 (1.4%) | 0/72 (0%) | |||
Thermal burn | 0/75 (0%) | 1/71 (1.4%) | 0/72 (0%) | |||
Metabolism and nutrition disorders | ||||||
Diabetic foot | 0/75 (0%) | 0/71 (0%) | 1/72 (1.4%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Arthralgia | 0/75 (0%) | 1/71 (1.4%) | 0/72 (0%) | |||
Intervertebral disc degeneration | 0/75 (0%) | 0/71 (0%) | 1/72 (1.4%) | |||
Rheumatoid arthritis | 1/75 (1.3%) | 0/71 (0%) | 0/72 (0%) | |||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
Bladder cancer | 0/75 (0%) | 1/71 (1.4%) | 0/72 (0%) | |||
Breast cancer | 1/75 (1.3%) | 0/71 (0%) | 0/72 (0%) | |||
Breast cancer metastatic | 0/75 (0%) | 0/71 (0%) | 1/72 (1.4%) | |||
Lung neoplasm malignant | 1/75 (1.3%) | 0/71 (0%) | 0/72 (0%) | |||
Nervous system disorders | ||||||
Coordination abnormal | 0/75 (0%) | 0/71 (0%) | 1/72 (1.4%) | |||
Diabetic neuropathy | 0/75 (0%) | 0/71 (0%) | 1/72 (1.4%) | |||
Transient ischaemic attack | 0/75 (0%) | 1/71 (1.4%) | 0/72 (0%) | |||
Renal and urinary disorders | ||||||
Renal artery stenosis | 0/75 (0%) | 0/71 (0%) | 1/72 (1.4%) | |||
Reproductive system and breast disorders | ||||||
Uterine prolapse | 1/75 (1.3%) | 0/71 (0%) | 0/72 (0%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Pulmonary embolism | 0/75 (0%) | 0/71 (0%) | 1/72 (1.4%) | |||
Vascular disorders | ||||||
Deep vein thrombosis | 0/75 (0%) | 0/71 (0%) | 1/72 (1.4%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Placebo | Denosumab 60 mg | Denosumab 180 mg | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 47/75 (62.7%) | 44/71 (62%) | 44/72 (61.1%) | |||
General disorders | ||||||
Fatigue | 3/75 (4%) | 6/71 (8.5%) | 0/72 (0%) | |||
Infections and infestations | ||||||
Bronchitis | 3/75 (4%) | 3/71 (4.2%) | 4/72 (5.6%) | |||
Influenza | 0/75 (0%) | 2/71 (2.8%) | 6/72 (8.3%) | |||
Nasopharyngitis | 9/75 (12%) | 5/71 (7%) | 5/72 (6.9%) | |||
Sinusitis | 8/75 (10.7%) | 4/71 (5.6%) | 8/72 (11.1%) | |||
Upper respiratory tract infection | 6/75 (8%) | 11/71 (15.5%) | 8/72 (11.1%) | |||
Urinary tract infection | 1/75 (1.3%) | 4/71 (5.6%) | 3/72 (4.2%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Arthralgia | 3/75 (4%) | 4/71 (5.6%) | 2/72 (2.8%) | |||
Back pain | 4/75 (5.3%) | 2/71 (2.8%) | 2/72 (2.8%) | |||
Rheumatoid arthritis | 24/75 (32%) | 22/71 (31%) | 21/72 (29.2%) | |||
Nervous system disorders | ||||||
Dizziness | 4/75 (5.3%) | 2/71 (2.8%) | 0/72 (0%) | |||
Headache | 1/75 (1.3%) | 1/71 (1.4%) | 4/72 (5.6%) | |||
Psychiatric disorders | ||||||
Insomnia | 4/75 (5.3%) | 1/71 (1.4%) | 3/72 (4.2%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Cough | 5/75 (6.7%) | 5/71 (7%) | 1/72 (1.4%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Name/Title | Study Director |
---|---|
Organization | Amgen Inc. |
Phone | 866-572-6436 |
- 20040144