Trial Outcomes & Findings for A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab (NCT NCT01457950)
NCT ID: NCT01457950
Last Updated: 2014-05-07
Results Overview
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 - measure at Baseline) divided by the measure at Baseline \* 100.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
135 participants
Primary outcome timeframe
Baseline and Month 6
Results posted on
2014-05-07
Participant Flow
This study consisted of a screening phase of up to 2.5 months, a six-month Double-Blind Treatment Phase and a six-month Open-Label Extension Phase. 371 participants (par.) were screened, 135 par. entered the Double-Blind Treatment Phase, and 123 par. continued into the Open-Label Extension Phase.
Participant milestones
| Measure |
Denosumab 60 mg
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
Denosumab 60 mg to Open-Label Denosumab 60mg
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
|
Placebo to Open-Label Denosumab 60 mg
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
|
|---|---|---|---|---|
|
Double-Blind Phase
STARTED
|
69
|
66
|
0
|
0
|
|
Double-Blind Phase
Completed the 6 Month Assessment
|
62
|
64
|
0
|
0
|
|
Double-Blind Phase
COMPLETED
|
60
|
63
|
0
|
0
|
|
Double-Blind Phase
NOT COMPLETED
|
9
|
3
|
0
|
0
|
|
Open-Label Phase
STARTED
|
0
|
0
|
60
|
63
|
|
Open-Label Phase
COMPLETED
|
0
|
0
|
58
|
61
|
|
Open-Label Phase
NOT COMPLETED
|
0
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Denosumab 60 mg
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
Denosumab 60 mg to Open-Label Denosumab 60mg
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
|
Placebo to Open-Label Denosumab 60 mg
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
|
|---|---|---|---|---|
|
Double-Blind Phase
Continuation Criteria Not Met
|
1
|
0
|
0
|
0
|
|
Double-Blind Phase
Protocol Violation
|
2
|
1
|
0
|
0
|
|
Double-Blind Phase
Withdrawal by Subject
|
6
|
2
|
0
|
0
|
|
Open-Label Phase
Adverse Event
|
0
|
0
|
0
|
1
|
|
Open-Label Phase
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Open-Label Phase
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
Baseline Characteristics
A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
Baseline characteristics by cohort
| Measure |
Denosumab 60 mg
n=69 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=66 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 Years
STANDARD_DEVIATION 4.86 • n=5 Participants
|
66.0 Years
STANDARD_DEVIATION 4.77 • n=7 Participants
|
66.5 Years
STANDARD_DEVIATION 4.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
69 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 6Population: Intent-to-Treat Efficacy (ITTE) Population: all participants who received one dose of study medication, and had a Baseline measure and at least one post-Baseline efficacy measure during the Double-Blind Treatment Phase.
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 - measure at Baseline) divided by the measure at Baseline \* 100.
Outcome measures
| Measure |
Denosumab 60 mg
n=68 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=66 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6
|
4.10 Percent change
Standard Error 0.407
|
0.89 Percent change
Standard Error 0.413
|
SECONDARY outcome
Timeframe: Baseline and Month 1Population: ITTE Population
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1 - measure at Baseline) divided by the measure at Baseline \* 100.
Outcome measures
| Measure |
Denosumab 60 mg
n=68 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=66 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1
|
1.35 Percent change
Standard Error 0.375
|
0.62 Percent change
Standard Error 0.380
|
SECONDARY outcome
Timeframe: Baseline, Month 1 and Month 6Population: ITTE Population
Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covarience (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1/6 - measure at Baseline) divided by the measure at Baseline \* 100.
Outcome measures
| Measure |
Denosumab 60 mg
n=69 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=64 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6
Fermoral neck, Month 6, n=69, 64
|
2.23 Percent change
Standard Error 0.330
|
0.84 Percent change
Standard Error 0.343
|
|
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6
Trochanter, Month n =69, 64
|
2.66 Percent change
Standard Error 0.418
|
0.67 Percent change
Standard Error 0.434
|
|
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6
Total hip, Month 1, n=67, 63
|
0.74 Percent change
Standard Error 0.238
|
0.05 Percent change
Standard Error 0.245
|
|
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6
Total hip, Month 6, n=69, 64
|
2.23 Percent change
Standard Error 0.245
|
0.57 Percent change
Standard Error 0.254
|
|
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6
Femoral neck, Month 1, n=67, 63
|
1.30 Percent change
Standard Error 0.344
|
-0.04 Percent change
Standard Error 0.354
|
|
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6
Trochanter, Month 1, n=67, 63
|
0.82 Percent change
Standard Error 0.380
|
0.39 Percent change
Standard Error 0.392
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3 and 6Population: ITTE Population. Only participants at the specified time points were analyzed.
Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline \* 100.
Outcome measures
| Measure |
Denosumab 60 mg
n=69 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=66 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6
s-PINP, Month 1, n=69, 66
|
-18.75 Percent change
Interval -35.71 to -6.0
|
-4.65 Percent change
Interval -17.86 to 9.68
|
|
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6
s-CTx, Month 1, n=69, 66
|
-80.72 Percent change
Interval -88.62 to -73.5
|
-14.48 Percent change
Interval -33.58 to -1.08
|
|
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6
s-CTx, Month 3, n=68, 65
|
-82.23 Percent change
Interval -89.0 to -73.67
|
-27.49 Percent change
Interval -44.85 to -5.13
|
|
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6
s-CTx, Month 6, n=60, 63
|
-74.32 Percent change
Interval -84.09 to -65.33
|
-21.21 Percent change
Interval -37.41 to 3.44
|
|
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6
s-PINP, Month 3, n=68, 65
|
-77.1 Percent change
Interval -83.54 to -68.57
|
-21.57 Percent change
Interval -38.89 to -6.35
|
|
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6
s-PINP, Month 6, n=60, 63
|
-76.18 Percent change
Interval -81.27 to -61.89
|
-21.05 Percent change
Interval -42.42 to -6.67
|
SECONDARY outcome
Timeframe: From Baseline up to Month 6Population: Intent-to-Treat (ITT) Population: all participants who received one dose of study medication.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Outcome measures
| Measure |
Denosumab 60 mg
n=69 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=66 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)
Any AE
|
38 Participants
|
32 Participants
|
|
Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)
Any SAE
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Only participants at the specified time points were analyzed.
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6
Albumin/globulin ratio, n=60, 63
|
0.020 Ratio
Standard Deviation 0.1424
|
0.052 Ratio
Standard Deviation 0.1390
|
|
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6
BUN/creatinine ratio, n=60, 63
|
-7.917 Ratio
Standard Deviation 25.2917
|
-4.063 Ratio
Standard Deviation 27.3436
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Only participants at the specified time points were analyzed.
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6
Total protein, n=60, 63
|
-0.050 Grams (G)/Liter (L)
Standard Deviation 2.9939
|
-0.127 Grams (G)/Liter (L)
Standard Deviation 3.3864
|
|
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6
Albumin, n=60,63
|
0.217 Grams (G)/Liter (L)
Standard Deviation 1.8964
|
0.365 Grams (G)/Liter (L)
Standard Deviation 2.2598
|
|
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6
Hemoglobin, n=59, 63
|
1.153 Grams (G)/Liter (L)
Standard Deviation 5.8274
|
1.778 Grams (G)/Liter (L)
Standard Deviation 5.6894
|
|
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6
Mean corpuscle hemoglobin concentration, n=59, 63
|
-5.186 Grams (G)/Liter (L)
Standard Deviation 9.9264
|
-6.857 Grams (G)/Liter (L)
Standard Deviation 9.4593
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Only participants at the specified time points were analyzed. .
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6
Creatine kinase, n=60, 63
|
7.617 Internationational Units(IU)/Liter (L)
Standard Deviation 51.6658
|
3.905 Internationational Units(IU)/Liter (L)
Standard Deviation 31.2052
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6
Gamma glutamyl transferase, n=60, 63
|
-0.133 Internationational Units(IU)/Liter (L)
Standard Deviation 8.4381
|
-2.143 Internationational Units(IU)/Liter (L)
Standard Deviation 7.9532
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6
Alkaline phosphatase, n=60, 63
|
-24.283 Internationational Units(IU)/Liter (L)
Standard Deviation 15.9513
|
-8.222 Internationational Units(IU)/Liter (L)
Standard Deviation 11.2127
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6
Alanine amino transferase, n=60, 63
|
2.117 Internationational Units(IU)/Liter (L)
Standard Deviation 6.4047
|
-0.397 Internationational Units(IU)/Liter (L)
Standard Deviation 8.8035
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6
Aspartate amino transferase, n=59, 63
|
1.034 Internationational Units(IU)/Liter (L)
Standard Deviation 4.4527
|
-0.032 Internationational Units(IU)/Liter (L)
Standard Deviation 7.4962
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6
Lactate dehydraogenase, n=59, 63
|
6.119 Internationational Units(IU)/Liter (L)
Standard Deviation 18.1156
|
3.889 Internationational Units(IU)/Liter (L)
Standard Deviation 20.4979
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Only participants at the specified time points were analyzed.
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=58 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6
Eosinophils, n=58, 63
|
-0.019 10^9 cells per liter (GI/L)
Standard Deviation 0.1254
|
-0.033 10^9 cells per liter (GI/L)
Standard Deviation 0.1309
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6
Basophils, n=58, 63
|
-0.003 10^9 cells per liter (GI/L)
Standard Deviation 0.0131
|
-0.006 10^9 cells per liter (GI/L)
Standard Deviation 0.0165
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6
Lymphocytes, n=58, 63
|
-0.047 10^9 cells per liter (GI/L)
Standard Deviation 0.4096
|
-0.206 10^9 cells per liter (GI/L)
Standard Deviation 0.5930
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6
Monocytes, n=58, 63
|
-0.033 10^9 cells per liter (GI/L)
Standard Deviation 0.1094
|
-0.059 10^9 cells per liter (GI/L)
Standard Deviation 0.1324
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6
Segmented neutrophils, n=58, 63
|
0.114 10^9 cells per liter (GI/L)
Standard Deviation 1.3382
|
-0.213 10^9 cells per liter (GI/L)
Standard Deviation 1.0934
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6
Total neutrophils, n=58, 63
|
0.114 10^9 cells per liter (GI/L)
Standard Deviation 1.3382
|
-0.213 10^9 cells per liter (GI/L)
Standard Deviation 1.0934
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6
Platelet count, n=58, 63
|
1.621 10^9 cells per liter (GI/L)
Standard Deviation 31.7881
|
-6.190 10^9 cells per liter (GI/L)
Standard Deviation 35.7874
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6
White blood cell count, n=58, 63
|
0.014 10^9 cells per liter (GI/L)
Standard Deviation 1.4026
|
-0.517 10^9 cells per liter (GI/L)
Standard Deviation 1.2003
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Only participants at the specified time points were analyzed.
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6
Direct bilirubin, n=60, 63
|
0.300 Micromole/liter (UMOL/L)
Standard Deviation 1.0301
|
0.222 Micromole/liter (UMOL/L)
Standard Deviation 1.1974
|
|
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6
Indirect bilirubin, n=60, 63
|
1.567 Micromole/liter (UMOL/L)
Standard Deviation 3.4757
|
0.508 Micromole/liter (UMOL/L)
Standard Deviation 3.5372
|
|
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6
Total bilirubin, n=60, 63
|
1.867 Micromole/liter (UMOL/L)
Standard Deviation 3.8947
|
0.730 Micromole/liter (UMOL/L)
Standard Deviation 3.8404
|
|
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6
Creatinine, n=60, 63
|
2.037 Micromole/liter (UMOL/L)
Standard Deviation 6.4916
|
0.940 Micromole/liter (UMOL/L)
Standard Deviation 5.1644
|
|
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6
Uric acid, n=60, 63
|
11.500 Micromole/liter (UMOL/L)
Standard Deviation 38.9622
|
0.159 Micromole/liter (UMOL/L)
Standard Deviation 40.9757
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Only participants at the specified time points were analyzed.
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
Potassium, n=59, 63
|
0.000 Millimole/Liter (MMOL/L)
Standard Deviation 0.3900
|
0.060 Millimole/Liter (MMOL/L)
Standard Deviation 0.3476
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
Magnesium, n=60, 63
|
0.004 Millimole/Liter (MMOL/L)
Standard Deviation 0.0585
|
0.009 Millimole/Liter (MMOL/L)
Standard Deviation 0.0462
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
Calcium (corrected), n=1, 1
|
0.110 Millimole/Liter (MMOL/L)
Standard Deviation NA
Only one participant was analyzed; therefore, the standard deviation was undefined.
|
0.000 Millimole/Liter (MMOL/L)
Standard Deviation NA
Only one participant was analyzed; therefore, the standard deviation was undefined.
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
Calcium, n=59, 63
|
-0.020 Millimole/Liter (MMOL/L)
Standard Deviation 0.0890
|
0.002 Millimole/Liter (MMOL/L)
Standard Deviation 0.0768
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
Chloride, n=60, 63
|
-0.200 Millimole/Liter (MMOL/L)
Standard Deviation 2.2981
|
0.444 Millimole/Liter (MMOL/L)
Standard Deviation 2.3264
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
Glucose, n=60, 63
|
-0.873 Millimole/Liter (MMOL/L)
Standard Deviation 2.5458
|
-0.567 Millimole/Liter (MMOL/L)
Standard Deviation 1.2118
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
Sodium, n=60, 63
|
-0.400 Millimole/Liter (MMOL/L)
Standard Deviation 2.1249
|
0.095 Millimole/Liter (MMOL/L)
Standard Deviation 1.9486
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
Phosphorus inorganic, n=60, 63
|
-0.072 Millimole/Liter (MMOL/L)
Standard Deviation 0.1505
|
-0.063 Millimole/Liter (MMOL/L)
Standard Deviation 0.1695
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
Triglycerides, n=60, 63
|
-0.166 Millimole/Liter (MMOL/L)
Standard Deviation 0.7155
|
-0.156 Millimole/Liter (MMOL/L)
Standard Deviation 0.6119
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
Urea/BUN, n=60, 63
|
-0.258 Millimole/Liter (MMOL/L)
Standard Deviation 1.1878
|
-0.119 Millimole/Liter (MMOL/L)
Standard Deviation 1.4134
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
VLDL cholesterol calculation, n=59, 63
|
-0.098 Millimole/Liter (MMOL/L)
Standard Deviation 0.2844
|
-0.072 Millimole/Liter (MMOL/L)
Standard Deviation 0.2810
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Only participants at the specified time points were analyzed.
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=59 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Hematocrit at Month 6
|
0.009 Proportion of RBCs in blood
Standard Deviation 0.0196
|
0.013 Proportion of RBCs in blood
Standard Deviation 0.0196
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Only participants at the specified time points were analyzed.
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=59 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Mean Corpuscle Hemoglobin at Month 6
|
0.068 Picograms (PG)/cell
Standard Deviation 0.7111
|
0.146 Picograms (PG)/cell
Standard Deviation 0.6696
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Only participants at the specified time points were analyzed.
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=59 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Mean Corpuscular Volume at Month 6
|
1.695 Femtoliters (FL)
Standard Deviation 2.5000
|
2.397 Femtoliters (FL)
Standard Deviation 2.6368
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Only participants at the specified time points were analyzed.
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=59 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Red Blood Cell Count at Month 6
|
0.025 10^12 cells per liter (TI/L)
Standard Deviation 0.1844
|
0.037 10^12 cells per liter (TI/L)
Standard Deviation 0.1920
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Only participants at the specified time points were analyzed.
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=59 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Red Cell Distribution Width at Month 6
|
0.475 percentage (%) of mean RBC volume
Standard Deviation 1.0256
|
0.556 percentage (%) of mean RBC volume
Standard Deviation 0.9242
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Only participants at the specified time points were analyzed.
Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (\<50 or \>120 Bits Per Minutes \[bpm\]), Systolic Blood Pressure (\>170 Millimeters of Mercury \[mmHg\] or \<100 mmHg) and Heart rate (\>110 mmHg or \<50 mmHg) are summarized. Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6
Systolic blood pressure, High, n=60, 63
|
1 Participants
|
2 Participants
|
|
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6
Diastolic blood pressure, Low, n=60, 63
|
0 Participants
|
2 Participants
|
|
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6
Systolic blood pressure, Low, n=60, 63
|
1 Participants
|
1 Participants
|
|
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6
Heart rate, High, n=60, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6
Heart rate, Low, n=60, 63
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 6Population: ITT Population. Only participants at the specified time points were analyzed.
Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 6 was summarized.
Outcome measures
| Measure |
Denosumab 60 mg
n=69 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=66 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab
Neutralizing antibodies, Positive, n=0, 0
|
NA Participants
There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.
|
NA Participants
There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.
|
|
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab
Neutralizing antibodies, Negative, n=0, 0
|
NA Participants
There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.
|
NA Participants
There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.
|
|
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab
Binding antibodies, Positive, n=60, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab
Binding antibodies, Negative, n=60, 63
|
60 Participants
|
63 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 12Population: Intent-to-Treat Open-Label (ITT-OL) Population: all participants from the ITT population in the Double-Blind Phase who continued into the Open-Label Extension Phase of the study and received denosumab at Month 6. Ony those participants with a value at Baseline and Month 12 were analyzed.
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline \* 100.
Outcome measures
| Measure |
Denosumab 60 mg
n=59 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab
|
5.62 Percent change
Standard Error 3.776
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6 and Month 12Population: ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.
Mean percent change from Month 6 in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 \* 100.
Outcome measures
| Measure |
Denosumab 60 mg
n=59 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Mean Percent Change From Month 6 in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Placebo
|
2.67 Percent change
Standard Error 3.440
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 12Population: ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.
Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline \* 100.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab
Total hip
|
3.07 Percent change
Standard Error 2.476
|
—
|
|
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab
Femoral neck
|
3.39 Percent change
Standard Error 3.158
|
—
|
|
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab
Trochanter
|
3.39 Percent change
Standard Error 4.653
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6 and Month 12Population: ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.
Mean percent change from Month 6 in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 \* 100.
Outcome measures
| Measure |
Denosumab 60 mg
n=56 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo
Total hip
|
1.46 Percent change
Standard Error 1.701
|
—
|
|
Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo
Femoral neck
|
1.12 Percent change
Standard Error 2.668
|
—
|
|
Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo
Trochanter
|
2.13 Percent change
Standard Error 2.762
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 12Population: ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.
Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline \* 100.
Outcome measures
| Measure |
Denosumab 60 mg
n=57 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab
s-CTx
|
-63.36 Percent change
Interval -77.14 to -48.62
|
—
|
|
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab
s-PINP
|
-78.00 Percent change
Interval -84.31 to -66.67
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6 and Month 12Population: ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.
Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by measure at Month 6 \* 100.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo
s-CTx
|
-50.90 Percent change
Interval -71.95 to -24.05
|
—
|
|
Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo
s-PINP
|
-66.67 Percent change
Interval -76.82 to -55.65
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Month 6 to Month 12Population: ITT-OL Population
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase
Any AE
|
22 Participants
|
29 Participants
|
|
Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase
Any SAE
|
1 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 12Population: ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12
Albumin/globulin ratio, n=58, 60
|
0.016 Ratio
Standard Deviation 0.1473
|
0.032 Ratio
Standard Deviation 0.1621
|
|
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12
BUN/creatinine ratio, n=58, 60
|
-5.776 Ratio
Standard Deviation 24.4297
|
2.500 Ratio
Standard Deviation 27.7962
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 12Population: ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12
Total protein, n=58, 60
|
0.224 Grams (G)/Liter (L)
Standard Deviation 3.4946
|
0.267 Grams (G)/Liter (L)
Standard Deviation 2.8216
|
|
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12
Albumin, n=58, 60
|
0.293 Grams (G)/Liter (L)
Standard Deviation 2.1110
|
0.450 Grams (G)/Liter (L)
Standard Deviation 1.9866
|
|
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12
Hemoglobin, n=56, 60
|
1.411 Grams (G)/Liter (L)
Standard Deviation 5.7833
|
2.033 Grams (G)/Liter (L)
Standard Deviation 6.0084
|
|
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12
Mean corpuscle hemoglobin concentration, n=56, 60
|
-5.679 Grams (G)/Liter (L)
Standard Deviation 6.6143
|
-6.650 Grams (G)/Liter (L)
Standard Deviation 7.7587
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 12Population: ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12
Alkaline phosphatase, n=58, 60
|
-25.603 Internationational Units(IU)/Liter (L)
Standard Deviation 14.4780
|
-23.767 Internationational Units(IU)/Liter (L)
Standard Deviation 15.7570
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12
Alanine amino transferase, n=58, 60
|
1.810 Internationational Units(IU)/Liter (L)
Standard Deviation 7.9922
|
-0.150 Internationational Units(IU)/Liter (L)
Standard Deviation 8.9288
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12
Aspartate amino transferase, n=58, 60
|
0.879 Internationational Units(IU)/Liter (L)
Standard Deviation 6.4293
|
-0.467 Internationational Units(IU)/Liter (L)
Standard Deviation 6.2666
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12
Creatine kinase, n=58, 60
|
-4.534 Internationational Units(IU)/Liter (L)
Standard Deviation 44.0690
|
4.500 Internationational Units(IU)/Liter (L)
Standard Deviation 52.0731
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12
Gamma glutamyl transferase, n=58, 60
|
0.4823 Internationational Units(IU)/Liter (L)
Standard Deviation 6.9541
|
-0.600 Internationational Units(IU)/Liter (L)
Standard Deviation 9.4961
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12
Lactate dehydraogenase, n=58, 60
|
-0.552 Internationational Units(IU)/Liter (L)
Standard Deviation 19.2237
|
-1.217 Internationational Units(IU)/Liter (L)
Standard Deviation 24.7243
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 12Population: ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12
Basophils, n=54, 59
|
-0.004 10^9 cells per liter (GI/L)
Standard Deviation 0.0164
|
-0.002 10^9 cells per liter (GI/L)
Standard Deviation 0.0148
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12
Eosinophils, n=54, 59
|
0.024 10^9 cells per liter (GI/L)
Standard Deviation 0.1489
|
0.019 10^9 cells per liter (GI/L)
Standard Deviation 0.1860
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12
Lymphocytes, n=54, 59
|
0.098 10^9 cells per liter (GI/L)
Standard Deviation 0.4436
|
-0.089 10^9 cells per liter (GI/L)
Standard Deviation 0.5599
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12
Monocytes, n=54, 59
|
-0.009 10^9 cells per liter (GI/L)
Standard Deviation 0.1053
|
-0.039 10^9 cells per liter (GI/L)
Standard Deviation 0.1443
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12
Segmented neutrophils, n=54, 59
|
0.014 10^9 cells per liter (GI/L)
Standard Deviation 1.1748
|
-0.259 10^9 cells per liter (GI/L)
Standard Deviation 1.2035
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12
Total neutrophils, n=54, 59
|
0.014 10^9 cells per liter (GI/L)
Standard Deviation 1.1748
|
-0.259 10^9 cells per liter (GI/L)
Standard Deviation 1.2035
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12
Platelet count, n=55, 60
|
-4.018 10^9 cells per liter (GI/L)
Standard Deviation 34.8215
|
-4.233 10^9 cells per liter (GI/L)
Standard Deviation 37.7913
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12
White blood cell count, n=54, 59
|
0.122 10^9 cells per liter (GI/L)
Standard Deviation 1.1618
|
-0.369 10^9 cells per liter (GI/L)
Standard Deviation 1.3903
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 12Population: ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12
Uric acid, n=58, 60
|
4.483 Micromole/liter (UMOL/L)
Standard Deviation 41.3870
|
2.000 Micromole/liter (UMOL/L)
Standard Deviation 44.0647
|
|
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12
Direct bilirubin, n=58, 60
|
0.241 Micromole/liter (UMOL/L)
Standard Deviation 1.3548
|
0.100 Micromole/liter (UMOL/L)
Standard Deviation 1.2980
|
|
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12
Indirect bilirubin, n=58, 60
|
1.034 Micromole/liter (UMOL/L)
Standard Deviation 4.0391
|
0.800 Micromole/liter (UMOL/L)
Standard Deviation 3.3385
|
|
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12
Total bilirubin, n=58, 60
|
1.276 Micromole/liter (UMOL/L)
Standard Deviation 4.6596
|
0.900 Micromole/liter (UMOL/L)
Standard Deviation 3.5401
|
|
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12
Creatinine, n=58, 60
|
0.948 Micromole/liter (UMOL/L)
Standard Deviation 5.1157
|
-0.015 Micromole/liter (UMOL/L)
Standard Deviation 4.6216
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 12Population: ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12
Potassium, n=58, 60
|
0.047 Millimole/Liter (MMOL/L)
Standard Deviation 0.4398
|
0.045 Millimole/Liter (MMOL/L)
Standard Deviation 0.3078
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12
Triglycerides, n=58, 60
|
-0.144 Millimole/Liter (MMOL/L)
Standard Deviation 0.7716
|
-0.033 Millimole/Liter (MMOL/L)
Standard Deviation 0.8449
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12
Calcium (corrected), n=0, 0
|
NA Millimole/Liter (MMOL/L)
Standard Deviation NA
Zero participants was analyzed; therefore, the mean and the standard deviation were undefined.
|
NA Millimole/Liter (MMOL/L)
Standard Deviation NA
Zero participants was analyzed; therefore, the mean and the standard deviation were undefined.
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12
Calcium, n=58, 60
|
-0.031 Millimole/Liter (MMOL/L)
Standard Deviation 0.0944
|
-0.004 Millimole/Liter (MMOL/L)
Standard Deviation 0.0904
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12
Chloride, n=58, 60
|
0.328 Millimole/Liter (MMOL/L)
Standard Deviation 2.5573
|
0.300 Millimole/Liter (MMOL/L)
Standard Deviation 2.4446
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12
Glucose, n=58, 60
|
-0.760 Millimole/Liter (MMOL/L)
Standard Deviation 2.9331
|
-0.500 Millimole/Liter (MMOL/L)
Standard Deviation 1.2985
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12
Magnesium, n=58, 60
|
0.009 Millimole/Liter (MMOL/L)
Standard Deviation 0.0679
|
0.004 Millimole/Liter (MMOL/L)
Standard Deviation 0.0514
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12
Sodium, n=58, 60
|
-0.172 Millimole/Liter (MMOL/L)
Standard Deviation 2.1532
|
0.067 Millimole/Liter (MMOL/L)
Standard Deviation 2.2986
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12
Phosphorus inorganic, n=58, 60
|
-0.153 Millimole/Liter (MMOL/L)
Standard Deviation 0.1530
|
-0.094 Millimole/Liter (MMOL/L)
Standard Deviation 0.1981
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12
Urea/BUN, n=58, 60
|
-0.233 Millimole/Liter (MMOL/L)
Standard Deviation 1.2183
|
0.158 Millimole/Liter (MMOL/L)
Standard Deviation 1.5771
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12
VLDL cholesterol calculation, n=58, 59
|
-0.066 Millimole/Liter (MMOL/L)
Standard Deviation 0.3539
|
-0.044 Millimole/Liter (MMOL/L)
Standard Deviation 0.3234
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 12Population: ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=56 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=60 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Hematocrit at Month 12
|
0.010 Proportion of RBCs in blood
Standard Deviation 0.0182
|
0.014 Proportion of RBCs in blood
Standard Deviation 0.0185
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 12Population: ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=56 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=60 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Mean Corpuscle Hemoglobin at Month 12
|
-0.304 Picograms (PG)/cell)
Standard Deviation 0.7632
|
-0.310 Picograms (PG)/cell)
Standard Deviation 0.5058
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 12Population: ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=56 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=60 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Red Blood Cell Count at Month 12
|
0.086 10^12 cells per liter (TI/L)
Standard Deviation 0.1634
|
0.103 10^12 cells per liter (TI/L)
Standard Deviation 0.1904
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 12Population: ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=56 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=60 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Change From Baseline in Red Cell Distribution Width at Month 12
|
0.007 percentage (%) of mean RBC volume
Standard Deviation 0.7897
|
0.203 percentage (%) of mean RBC volume
Standard Deviation 0.8718
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 12Population: ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.
Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (\<50 or \>120 Bits Per Minutes \[bpm\]), Systolic Blood Pressure (\>170 Millimeters of Mercury \[mmHg\] or \<100 mmHg) and Heart rate (\>110 mmHg or \<50 mmHg) are summarized. Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Outcome measures
| Measure |
Denosumab 60 mg
n=58 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=61 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12
Diastolic blood pressure, High
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12
Diastolic blood pressure, Low
|
2 Participants
|
0 Participants
|
|
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12
Systolic blood pressure, High
|
0 Participants
|
2 Participants
|
|
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12
Systolic blood pressure, Low
|
0 Participants
|
2 Participants
|
|
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12
Heart rate, High
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12
Heart rate, Low
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Population: ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.
Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 12 was summarized.
Outcome measures
| Measure |
Denosumab 60 mg
n=60 Participants
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Placebo
n=63 Participants
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
|---|---|---|
|
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12
Neutralizing antibodies, Positive, n=0, 0
|
NA Participants
There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.
|
NA Participants
There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.
|
|
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12
Binding antibodies, Negative, n=58, 61
|
58 Participants
|
61 Participants
|
|
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12
Neutralizing antibodies, Negative, n=0, 0
|
NA Participants
There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.
|
NA Participants
There were no binding antibody confirmed positive tests; therefore, neutralizing antibody testing was not performed.
|
|
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12
Binding antibodies, Positive, n=58, 61
|
0 Participants
|
0 Participants
|
Adverse Events
Randomized Phase: Denosumab 60 mg
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Randomized Phase: Placebo
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Open Label Denosumab 60 mg (Previously Randomized Denosumab)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Open Label Denosumab 60 mg (Previously Randomized Placebo)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Randomized Phase: Denosumab 60 mg
n=69 participants at risk
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Randomized Phase: Placebo
n=66 participants at risk
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
Open Label Denosumab 60 mg (Previously Randomized Denosumab)
n=60 participants at risk
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
|
Open Label Denosumab 60 mg (Previously Randomized Placebo)
n=63 participants at risk
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.9%
2/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
1.5%
1/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
1.5%
1/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Infections and infestations
Bronchitis
|
1.4%
1/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.4%
1/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
1.4%
1/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.4%
1/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
1.4%
1/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
1.4%
1/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
1.4%
1/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
1.4%
1/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.4%
1/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
1.6%
1/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Eye disorders
Macular hole
|
0.00%
0/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
1.7%
1/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
1.6%
1/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
1.6%
1/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
Other adverse events
| Measure |
Randomized Phase: Denosumab 60 mg
n=69 participants at risk
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]).
|
Randomized Phase: Placebo
n=66 participants at risk
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
|
Open Label Denosumab 60 mg (Previously Randomized Denosumab)
n=60 participants at risk
Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
|
Open Label Denosumab 60 mg (Previously Randomized Placebo)
n=63 participants at risk
Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.2%
5/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
3.0%
2/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.8%
4/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
1.5%
1/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
4/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
12.1%
8/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
10.0%
6/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
9.5%
6/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
5.0%
3/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
1.6%
1/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
5.0%
3/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/69 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
0.00%
0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
5.0%
3/60 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
1.6%
1/63 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of the Open-Label Phase (up to Month 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received one dose of study medication during the Double-Blind Treatment Phase, and for members of ITT-OL Population in the Open-Label Phase.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER