Trial Outcomes & Findings for Preventing Osteoporosis Using Denosumab (NCT NCT02753283)
NCT ID: NCT02753283
Last Updated: 2024-09-19
Results Overview
Bone Mineral Density (BMD) of the total hip percent change over 24 months as assessed by dual-energy x-ray absorptiometry (DXA)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
201 participants
Primary outcome timeframe
24 months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Women Denosumab
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Women Placebo Group
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Denosumab
Semi-annual dose for men: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Placebo Group
Semi-annual for men: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
62
|
61
|
40
|
38
|
|
Overall Study
COMPLETED
|
45
|
43
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
17
|
18
|
12
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preventing Osteoporosis Using Denosumab
Baseline characteristics by cohort
| Measure |
Women Denosumab
n=62 Participants
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Women Placebo Group
n=61 Participants
Semi-annual for women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Denosumab
n=40 Participants
Semi-annual dose for men: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Placebo Group
n=38 Participants
Semi-annual for men: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
81.5 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
80.0 Years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
82.6 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
82.7 Years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
81.5 Years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
123 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
58 participants
n=5 Participants
|
55 participants
n=7 Participants
|
37 participants
n=5 Participants
|
37 participants
n=4 Participants
|
187 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Bone Density of the Hip
|
.783 g/cm^2
STANDARD_DEVIATION .114 • n=5 Participants
|
.748 g/cm^2
STANDARD_DEVIATION .142 • n=7 Participants
|
.923 g/cm^2
STANDARD_DEVIATION .163 • n=5 Participants
|
.884 g/cm^2
STANDARD_DEVIATION .143 • n=4 Participants
|
.821 g/cm^2
STANDARD_DEVIATION .154 • n=21 Participants
|
|
Bone Density of Spine
|
1.038 g/cm^2
STANDARD_DEVIATION .178 • n=5 Participants
|
1.044 g/cm^2
STANDARD_DEVIATION .187 • n=7 Participants
|
1.221 g/cm^2
STANDARD_DEVIATION .217 • n=5 Participants
|
1.204 g/cm^2
STANDARD_DEVIATION .205 • n=4 Participants
|
1.108 g/cm^2
STANDARD_DEVIATION .210 • n=21 Participants
|
PRIMARY outcome
Timeframe: 24 monthsBone Mineral Density (BMD) of the total hip percent change over 24 months as assessed by dual-energy x-ray absorptiometry (DXA)
Outcome measures
| Measure |
Women Denosumab
n=40 Participants
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Women Placebo Group
n=38 Participants
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Denosumab
n=24 Participants
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Placebo Group
n=24 Participants
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
|---|---|---|---|---|
|
Bone Density of the Total Hip
|
4.62 Percent change
Standard Error 0.62
|
-0.19 Percent change
Standard Error 0.79
|
3.74 Percent change
Standard Error 0.55
|
0.48 Percent change
Standard Error 0.74
|
PRIMARY outcome
Timeframe: 24 monthsBone Mineral Density (BMD) of the spine percent change over 24 months as assessed by dual-energy x-ray absorptiometry (DXA)
Outcome measures
| Measure |
Women Denosumab
n=42 Participants
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Women Placebo Group
n=41 Participants
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Denosumab
n=26 Participants
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Placebo Group
n=25 Participants
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
|---|---|---|---|---|
|
Bone Density of the Spine
|
7.41 Percent change
Standard Error 0.93
|
2.15 Percent change
Standard Error 0.56
|
7.91 Percent change
Standard Error 0.96
|
1.12 Percent change
Standard Error 1.13
|
SECONDARY outcome
Timeframe: 24 MonthsPercent change over 24 months
Outcome measures
| Measure |
Women Denosumab
n=43 Participants
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Women Placebo Group
n=40 Participants
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Denosumab
n=26 Participants
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Placebo Group
n=25 Participants
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
|---|---|---|---|---|
|
Distal Radius BMD
|
2.030 Percent change from baseline
Standard Deviation 3.322
|
-.376 Percent change from baseline
Standard Deviation 3.894
|
2.386 Percent change from baseline
Standard Deviation 4.187
|
-1.115 Percent change from baseline
Standard Deviation 3.455
|
SECONDARY outcome
Timeframe: 24 MonthsPercent change over 24 months
Outcome measures
| Measure |
Women Denosumab
n=40 Participants
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Women Placebo Group
n=38 Participants
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Denosumab
n=24 Participants
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Placebo Group
n=24 Participants
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
|---|---|---|---|---|
|
Femoral Neck BMD
|
3.212 Percent change from baseline
Standard Deviation 5.207
|
.185 Percent change from baseline
Standard Deviation 4.195
|
2.932 Percent change from baseline
Standard Deviation 3.574
|
-.958 Percent change from baseline
Standard Deviation 5.926
|
SECONDARY outcome
Timeframe: 24 MonthsTrabecular Bone Score (TBS) Percent change over 24 months. This not a scale. Higher values are better.
Outcome measures
| Measure |
Women Denosumab
n=36 Participants
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Women Placebo Group
n=37 Participants
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Denosumab
n=22 Participants
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Placebo Group
n=20 Participants
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
|---|---|---|---|---|
|
TBS
|
3.007 Percent change from baseline
Standard Deviation 5.990
|
1.099 Percent change from baseline
Standard Deviation 5.498
|
2.370 Percent change from baseline
Standard Deviation 6.645
|
3.318 Percent change from baseline
Standard Deviation 6.688
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 MonthsBone Turnover Marker change from Baseline
Outcome measures
| Measure |
Women Denosumab
n=47 Participants
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Women Placebo Group
n=42 Participants
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Denosumab
n=35 Participants
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Placebo Group
n=29 Participants
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
|---|---|---|---|---|
|
CTX
|
-.190 nmol/L
Standard Deviation .206
|
-.078 nmol/L
Standard Deviation .181
|
-.178 nmol/L
Standard Deviation .211
|
-.071 nmol/L
Standard Deviation .177
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 MonthsBone Turnover Marker Change from Baseline
Outcome measures
| Measure |
Women Denosumab
n=47 Participants
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Women Placebo Group
n=42 Participants
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Denosumab
n=35 Participants
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Placebo Group
n=29 Participants
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
|---|---|---|---|---|
|
P1NP
|
-25.345 ug/L
Standard Deviation 21.367
|
-3.158 ug/L
Standard Deviation 22.633
|
-19.539 ug/L
Standard Deviation 28.219
|
-10.731 ug/L
Standard Deviation 21.548
|
Adverse Events
Women Denosumab
Serious events: 21 serious events
Other events: 46 other events
Deaths: 1 deaths
Women Placebo Group
Serious events: 26 serious events
Other events: 50 other events
Deaths: 4 deaths
Men Denosumab
Serious events: 21 serious events
Other events: 32 other events
Deaths: 4 deaths
Men Placebo Group
Serious events: 15 serious events
Other events: 33 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Women Denosumab
n=62 participants at risk
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Women Placebo Group
n=61 participants at risk
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Denosumab
n=40 participants at risk
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Placebo Group
n=38 participants at risk
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adenoviral upper respiratory infection
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Cardiac disorders
Atrial Fibrillation
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Cardiac disorders
Bradycardia
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Cardiac disorders
Cardiac failure congestive
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
4.9%
3/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
10.0%
4/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.3%
2/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Cardiac disorders
Chest Pain
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
6.6%
4/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Cardiac disorders
Sinus bradycardia
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Eye disorders
Diplopia
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Eye disorders
Dry Eye
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Gastrointestinal disorders
Faecaloma
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
3.3%
2/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
2/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
General disorders
Asthenia
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
General disorders
Complication associated with device
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
General disorders
Death
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
6.6%
4/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
10.0%
4/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.3%
2/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
General disorders
Incarcerated hernia
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
General disorders
Pain
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Infections and infestations
Bacteremia
|
3.2%
2/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Infections and infestations
Bronchitis
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Infections and infestations
Pneumonia
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
7.5%
3/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
2/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Metabolism and nutrition disorders
Anorexia
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Metabolism and nutrition disorders
Diabetes
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
3.2%
2/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Musculoskeletal and connective tissue disorders
Femur Fracture
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
3.2%
2/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Musculoskeletal and connective tissue disorders
Inflammatory polyarthritis
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Musculoskeletal and connective tissue disorders
Lumbar vertebral fracture
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenosquamous cell carcinoma
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenosquamous cell lung cancer
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell small lymphocytic lymphoma
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
3.3%
2/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.3%
2/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Ataxia
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Cerebrovascular accident
|
4.8%
3/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Confusional state
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Dizziness
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Hemiparesis
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Internal capsule infarction
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Ischemic cerebral infarction
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Lacunar stroke
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Normal Pressure Hydrocephalus
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Seizure
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Syncope
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
3.3%
2/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Transient ischemic attack
|
4.8%
3/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Product Issues
Device malfunction
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Psychiatric disorders
Delirium
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Psychiatric disorders
Depression
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Renal and urinary disorders
Genitourinary tract infection
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Renal and urinary disorders
Urinary tract infection
|
3.2%
2/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
4.9%
3/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Renal and urinary disorders
Urosepsis
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.3%
2/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
3.3%
2/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.3%
2/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Respiratory, thoracic and mediastinal disorders
Lobar Pneumonia
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
3.3%
2/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Surgical and medical procedures
Brachytherapy to prostate
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
4.9%
3/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Surgical and medical procedures
Hysterosalpingo-oophorectomy
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
3.3%
2/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Vascular disorders
Embolic stroke
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Vascular disorders
Hypertension
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Vascular disorders
Pulmonary embolism
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
Other adverse events
| Measure |
Women Denosumab
n=62 participants at risk
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Women Placebo Group
n=61 participants at risk
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Denosumab
n=40 participants at risk
Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
denosumab: Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
Men Placebo Group
n=38 participants at risk
Semi-annual for Women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Placebo: Semi-annual saline injection
Calcium and Vitamin D: Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
4/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
3.3%
2/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
General disorders
Fatigue
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
7.5%
3/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
General disorders
Pain
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.0%
2/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Infections and infestations
Bronchitis
|
4.8%
3/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
3.3%
2/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.0%
2/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Infections and infestations
Pneumonia
|
3.2%
2/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.3%
2/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Infections and infestations
Sinusitis
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
3.3%
2/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.0%
2/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.1%
5/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
6.6%
4/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.3%
2/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
3.3%
2/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.3%
2/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Injury, poisoning and procedural complications
Fall
|
38.7%
24/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
39.3%
24/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
40.0%
16/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
44.7%
17/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.9%
8/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
14.8%
9/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.0%
2/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.1%
5/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
3.3%
2/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
8.1%
5/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
4.9%
3/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.0%
2/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.3%
2/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.0%
2/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Confusional State
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
7.5%
3/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Dizziness
|
4.8%
3/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
7.5%
3/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Headache
|
4.8%
3/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
7.9%
3/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Nervous system disorders
Syncope
|
0.00%
0/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.0%
2/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Renal and urinary disorders
Hematuria
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
7.9%
3/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Renal and urinary disorders
Urinary Tract Infection
|
11.3%
7/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
13.1%
8/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.0%
2/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.3%
2/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Respiratory, thoracic and mediastinal disorders
Adenoviral Upper Respiratory Infection
|
6.5%
4/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
7.9%
3/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
7.9%
3/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
6.6%
4/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.5%
1/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.3%
2/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.0%
2/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
4/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
3.3%
2/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
2.6%
1/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
1.6%
1/62 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
1.6%
1/61 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
5.0%
2/40 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
0.00%
0/38 • 24 Months
Subjects were asked every six months about adverse events, supplemented by automated reporting system
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place