Trial Outcomes & Findings for Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients (NCT NCT01377467)
NCT ID: NCT01377467
Last Updated: 2016-05-26
Results Overview
The total lumbar spine BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite
COMPLETED
PHASE3
90 participants
Baseline and month 12
2016-05-26
Participant Flow
Patients were recruited from June 20, 2011, to May 2, 2014. Patients were randomized after 15.7 ± 6.4 days after transplantation.
Participant milestones
| Measure |
Denosumab
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
No treatment
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
44
|
|
Overall Study
COMPLETED
|
46
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients
Baseline characteristics by cohort
| Measure |
Denosumab
n=46 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=44 Participants
No treatment
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 16.0 • n=113 Participants
|
52.9 years
STANDARD_DEVIATION 14.0 • n=163 Participants
|
50.9 years
STANDARD_DEVIATION 15.1 • n=160 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=113 Participants
|
25 Participants
n=163 Participants
|
52 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=113 Participants
|
19 Participants
n=163 Participants
|
38 Participants
n=160 Participants
|
|
Region of Enrollment
Switzerland
|
46 participants
n=113 Participants
|
44 participants
n=163 Participants
|
90 participants
n=160 Participants
|
|
Number of osteopenic patients
Yes
|
16 participants
n=113 Participants
|
25 participants
n=163 Participants
|
41 participants
n=160 Participants
|
|
Number of osteopenic patients
No
|
30 participants
n=113 Participants
|
19 participants
n=163 Participants
|
49 participants
n=160 Participants
|
|
Number of osteoporotic patients
Yes
|
3 participants
n=113 Participants
|
6 participants
n=163 Participants
|
9 participants
n=160 Participants
|
|
Number of osteoporotic patients
No
|
43 participants
n=113 Participants
|
38 participants
n=163 Participants
|
81 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Baseline and month 12Population: The intention-to-treat (ITT) population was used for the primary efficacy analysis, i.e. all subjects were included that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).
The total lumbar spine BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite
Outcome measures
| Measure |
Denosumab
n=46 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=44 Participants
No treatment
|
|---|---|---|
|
Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12
|
4.5 percent change
Standard Deviation 3.8
|
-0.3 percent change
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).
The total hip BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite
Outcome measures
| Measure |
Denosumab
n=46 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=44 Participants
No treatment
|
|---|---|---|
|
Percent Change in BMD at the Total Hip From Baseline to Month 12
|
2.3 percent change
Standard Deviation 3.7
|
0.5 percent change
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: The intention-to-treat (ITT) was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).
The total femoral neck BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite
Outcome measures
| Measure |
Denosumab
n=46 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=44 Participants
No treatment
|
|---|---|---|
|
Percent Change in BMD at the Femoral Neck From Baseline to Month 12
|
1.1 percent change
Standard Deviation 4.7
|
0.8 percent change
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Baseline and month 6Population: The intention-to-treat was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).
The total lumbar spine BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite.
Outcome measures
| Measure |
Denosumab
n=46 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=44 Participants
No treatment
|
|---|---|---|
|
Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 6
|
2.9 percent change
Standard Deviation 3.3
|
-1.5 percent change
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline and month 6Population: The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).
The total hip BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite
Outcome measures
| Measure |
Denosumab
n=46 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=44 Participants
No treatment
|
|---|---|---|
|
Percent Change in BMD at the Total Hip From Baseline to Month 6
|
1.4 percent change
Standard Deviation 2.4
|
-0.3 percent change
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline and month 6Population: The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).
The femoral neck BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite
Outcome measures
| Measure |
Denosumab
n=46 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=44 Participants
No treatment
|
|---|---|---|
|
Percent Change in BMD at the Femoral Neck From Baseline to Month 6
|
1.0 percent change
Standard Deviation 4.0
|
-0.8 percent change
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: baseline, month 3, month 6, and month 12Population: For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.
Blood concentrations of beta-CTX (microgram/L)
Outcome measures
| Measure |
Denosumab
n=42 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=42 Participants
No treatment
|
|---|---|---|
|
Beta-CTX at Baseline and Months 3, 6 and 12
baseline
|
0.635 microgram/L
Interval 0.508 to 0.741
|
0.772 microgram/L
Interval 0.665 to 0.878
|
|
Beta-CTX at Baseline and Months 3, 6 and 12
month 3
|
0.129 microgram/L
Interval 0.037 to 0.221
|
0.590 microgram/L
Interval 0.498 to 0.682
|
|
Beta-CTX at Baseline and Months 3, 6 and 12
month 6
|
0.204 microgram/L
Interval 0.077 to 0.33
|
0.612 microgram/L
Interval 0.485 to 0.739
|
|
Beta-CTX at Baseline and Months 3, 6 and 12
month 12
|
0.389 microgram/L
Interval 0.154 to 0.623
|
0.794 microgram/L
Interval 0.559 to 1.028
|
SECONDARY outcome
Timeframe: baseline, month 3, month 6, and month 12Population: For this endpoints, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.
Blood concentrations of P1NP were measured in microgram/L
Outcome measures
| Measure |
Denosumab
n=42 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=41 Participants
No treatment
|
|---|---|---|
|
P1NP at Baseline and Months 3, 6 and 12
month 6
|
35.347 microgram/L
Interval 11.525 to 59.169
|
107.072 microgram/L
Interval 82.962 to 131.18
|
|
P1NP at Baseline and Months 3, 6 and 12
month 12
|
57.953 microgram/L
Interval 33.685 to 82.221
|
132.439 microgram/L
Interval 107.876 to 157.0
|
|
P1NP at Baseline and Months 3, 6 and 12
baseline
|
61.222 microgram/L
Interval 47.974 to 74.47
|
77.808 microgram/L
Interval 64.399 to 91.217
|
|
P1NP at Baseline and Months 3, 6 and 12
month 3
|
40.976 microgram/L
Interval 19.801 to 62.152
|
108.699 microgram/L
Interval 87.266 to 130.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, months 0.5, 1, 2, 3, 6, 12Population: For this endpoints, an available case analysis was performed, thus all randomised patients with valid data at all time points were included.
Blood levels of calcium (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, and 12
Outcome measures
| Measure |
Denosumab
n=30 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=35 Participants
No treatment
|
|---|---|---|
|
Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12
baseline
|
2.320 mmol/L
Interval 2.245 to 2.395
|
2.317 mmol/L
Interval 2.247 to 2.386
|
|
Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12
month 0.5
|
2.131 mmol/L
Interval 2.049 to 2.214
|
2.405 mmol/L
Interval 2.329 to 2.481
|
|
Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12
month 1
|
2.293 mmol/L
Interval 2.231 to 2.356
|
2.444 mmol/L
Interval 2.387 to 2.502
|
|
Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12
month 2
|
2.420 mmol/L
Interval 2.355 to 2.485
|
2.480 mmol/L
Interval 2.419 to 2.54
|
|
Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12
month 3
|
2.404 mmol/L
Interval 2.327 to 2.481
|
2.461 mmol/L
Interval 2.39 to 2.532
|
|
Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12
month 6
|
2.463 mmol/L
Interval 2.404 to 2.522
|
2.453 mmol/L
Interval 2.399 to 2.508
|
|
Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12
month 12
|
2.480 mmol/L
Interval 2.421 to 2.538
|
2.509 mmol/L
Interval 2.455 to 2.563
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, months 0.5, 1, 2, 3, 6, 12Population: For this endpoints, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.
Blood levels of phosphate (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, 12
Outcome measures
| Measure |
Denosumab
n=32 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=36 Participants
No treatment
|
|---|---|---|
|
Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12
baseline
|
0.582 mmol/L
Interval 0.506 to 0.657
|
0.586 mmol/L
Interval 0.514 to 0.657
|
|
Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12
month 0.5
|
0.525 mmol/L
Interval 0.436 to 0.613
|
0.714 mmol/L
Interval 0.631 to 0.798
|
|
Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12
month 1
|
0.605 mmol/L
Interval 0.519 to 0.691
|
0.726 mmol/L
Interval 0.645 to 0.807
|
|
Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12
month 2
|
0.726 mmol/L
Interval 0.659 to 0.793
|
0.812 mmol/L
Interval 0.749 to 0.875
|
|
Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12
month 3
|
0.742 mmol/L
Interval 0.673 to 0.812
|
0.776 mmol/L
Interval 0.711 to 0.842
|
|
Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12
month 6
|
0.804 mmol/L
Interval 0.727 to 0.88
|
0.849 mmol/L
Interval 0.777 to 0.921
|
|
Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12
month 12
|
0.842 mmol/L
Interval 0.737 to 0.948
|
0.902 mmol/L
Interval 0.802 to 1.002
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and months 3, 6, and 12Population: For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.
Blood levels of PTH (ng/L) were measured at baseline and at months 3, 6, and 12
Outcome measures
| Measure |
Denosumab
n=40 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=40 Participants
No treatment
|
|---|---|---|
|
Blood Levels of PTH (ng/L) at Baseline and Months 3, 6, and 12
baseline
|
163.110 ng/L
Interval 115.906 to 210.314
|
147.300 ng/L
Interval 100.096 to 194.504
|
|
Blood Levels of PTH (ng/L) at Baseline and Months 3, 6, and 12
month 3
|
173.573 ng/L
Interval 130.141 to 217.004
|
111.563 ng/L
Interval 68.131 to 154.994
|
|
Blood Levels of PTH (ng/L) at Baseline and Months 3, 6, and 12
month 6
|
157.043 ng/L
Interval 117.092 to 196.993
|
99.420 ng/L
Interval 59.469 to 139.371
|
|
Blood Levels of PTH (ng/L) at Baseline and Months 3, 6, and 12
month 12
|
106.650 ng/L
Interval 85.078 to 128.222
|
100.705 ng/L
Interval 79.133 to 122.277
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, months 3, 6, and 12Population: For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.
Blood levels of 25-OH-vitamin D3 were measured as microgramm/L
Outcome measures
| Measure |
Denosumab
n=41 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=40 Participants
No treatment
|
|---|---|---|
|
25-OH-vitamin D3
baseline
|
17.378 microgramm/L
Interval 14.69 to 20.067
|
18.058 microgramm/L
Interval 15.336 to 20.779
|
|
25-OH-vitamin D3
month 3
|
21.632 microgramm/L
Interval 19.604 to 23.659
|
22.903 microgramm/L
Interval 20.85 to 24.955
|
|
25-OH-vitamin D3
month 6
|
24.395 microgramm/L
Interval 21.418 to 27.373
|
26.728 microgramm/L
Interval 23.713 to 29.742
|
|
25-OH-vitamin D3
month 12
|
28.546 microgramm/L
Interval 25.89 to 31.202
|
28.358 microgramm/L
Interval 25.669 to 31.046
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, months 3, 6, and 12Population: For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.
Blood levels of 1,25-(OH)2 vitamin D3 were measured as ng/L
Outcome measures
| Measure |
Denosumab
n=36 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=34 Participants
No treatment
|
|---|---|---|
|
1,25-(OH)2 Vitamin D3
month 6
|
54.175 ng/L
Interval 46.883 to 61.467
|
58.074 ng/L
Interval 50.57 to 65.577
|
|
1,25-(OH)2 Vitamin D3
month 12
|
47.208 ng/L
Interval 39.902 to 54.515
|
51.494 ng/L
Interval 43.976 to 59.013
|
|
1,25-(OH)2 Vitamin D3
baseline
|
29.556 ng/L
Interval 21.977 to 37.134
|
34.171 ng/L
Interval 26.373 to 41.969
|
|
1,25-(OH)2 Vitamin D3
month 3
|
60.533 ng/L
Interval 52.678 to 68.389
|
55.276 ng/L
Interval 47.193 to 63.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and month 12Population: Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.
Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.
Outcome measures
| Measure |
Denosumab
n=10 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=14 Participants
No treatment
|
|---|---|---|
|
Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Tibia
|
2.2 Percent change
Interval 0.7 to 3.2
|
-0.3 Percent change
Interval -3.3 to 2.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and month 12Population: Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.
Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.
Outcome measures
| Measure |
Denosumab
n=10 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=14 Participants
No treatment
|
|---|---|---|
|
Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Tibia
|
0.1 Percent change
Interval -0.5 to 1.4
|
-0.5 Percent change
Interval -2.0 to 0.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and month 12Population: Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.
Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.
Outcome measures
| Measure |
Denosumab
n=10 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=14 Participants
No treatment
|
|---|---|---|
|
Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Tibia
|
1.8 Percent change
Interval 1.3 to 4.2
|
1.1 Percent change
Interval -2.5 to 4.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and month 12Population: Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.
Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mm.
Outcome measures
| Measure |
Denosumab
n=10 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=14 Participants
No treatment
|
|---|---|---|
|
Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Tibia
|
2.8 Percent change
Interval 1.4 to 8.0
|
-0.9 Percent change
Interval -5.9 to 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and month 12Population: Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.
Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.
Outcome measures
| Measure |
Denosumab
n=10 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=14 Participants
No treatment
|
|---|---|---|
|
Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Radius
|
1.3 Percent change
Interval -1.9 to 2.2
|
-1.6 Percent change
Interval -5.2 to 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and month 12Population: Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.
Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.
Outcome measures
| Measure |
Denosumab
n=10 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=14 Participants
No treatment
|
|---|---|---|
|
Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Radius
|
-0.1 Percent change
Interval -1.8 to 1.3
|
-0.9 Percent change
Interval -2.7 to 0.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and month 12Population: Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.
Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.
Outcome measures
| Measure |
Denosumab
n=10 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=14 Participants
No treatment
|
|---|---|---|
|
Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Radius
|
2.4 Percent change
Interval 1.1 to 4.1
|
0.2 Percent change
Interval -9.4 to 3.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and month 12Population: Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.
Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mm.
Outcome measures
| Measure |
Denosumab
n=10 Participants
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=14 Participants
No treatment
|
|---|---|---|
|
Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Radius
|
0.9 Percent change
Interval -6.0 to 2.0
|
-3.6 Percent change
Interval -7.7 to -1.3
|
Adverse Events
Denosumab
Control
Serious adverse events
| Measure |
Denosumab
n=46 participants at risk
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=44 participants at risk
No treatment
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
23.9%
11/46 • Number of events 12 • 1 year
|
4.5%
2/44 • Number of events 6 • 1 year
|
|
Infections and infestations
Transplant pyelonephritis
|
6.5%
3/46 • Number of events 3 • 1 year
|
11.4%
5/44 • Number of events 5 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
3/46 • Number of events 3 • 1 year
|
4.5%
2/44 • Number of events 2 • 1 year
|
|
Infections and infestations
CMV viremia
|
2.2%
1/46 • Number of events 1 • 1 year
|
11.4%
5/44 • Number of events 5 • 1 year
|
|
Infections and infestations
Flu-like disease
|
2.2%
1/46 • Number of events 1 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
2/46 • Number of events 2 • 1 year
|
0.00%
0/44 • 1 year
|
|
Blood and lymphatic system disorders
Lymphocele
|
13.0%
6/46 • Number of events 6 • 1 year
|
13.6%
6/44 • Number of events 7 • 1 year
|
|
Immune system disorders
Acute rejection
|
4.3%
2/46 • Number of events 2 • 1 year
|
0.00%
0/44 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/46 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Vascular disorders
Thrombosis
|
2.2%
1/46 • Number of events 1 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/46 • 1 year
|
15.9%
7/44 • Number of events 7 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/46 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/46 • 1 year
|
4.5%
2/44 • Number of events 2 • 1 year
|
|
Endocrine disorders
Diabetes (post-transplant)
|
0.00%
0/46 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Surgical intervention
|
0.00%
0/46 • 1 year
|
4.5%
2/44 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Functional decline of transplant function
|
8.7%
4/46 • Number of events 5 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Transplant ureter stenosis
|
0.00%
0/46 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/46 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral arterial vascular disease
|
0.00%
0/46 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection
|
2.2%
1/46 • Number of events 1 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/46 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Transplant artery stenosis
|
0.00%
0/46 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Uterus myomatosus
|
0.00%
0/46 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Infections and infestations
Retinitis
|
0.00%
0/46 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Wound dehiscence
|
0.00%
0/46 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Bilateral nephrectomy of polycystic kidneys
|
0.00%
0/46 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Infections and infestations
Fever
|
6.5%
3/46 • Number of events 3 • 1 year
|
0.00%
0/44 • 1 year
|
|
Blood and lymphatic system disorders
Hematoma
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Vascular disorders
Pulmonary embolism
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck/back pain
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
General disorders
Generalized weakness
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Cardiac disorders
Chest pain
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Renal and urinary disorders
Ureteral leakage
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Infections and infestations
Abscess
|
6.5%
3/46 • Number of events 3 • 1 year
|
0.00%
0/44 • 1 year
|
|
Vascular disorders
Aneurysm
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Gastrointestinal disorders
Choledocholithiasis
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Endocrine disorders
Hyponatremia
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Infections and infestations
Infection without focus
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Gastrointestinal disorders
Ileus
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Surgical and medical procedures
Transplant reflux testing
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Surgical and medical procedures
Selective ureteral sampling
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Infections and infestations
Tonsillitis
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Renal and urinary disorders
Urethral stricture
|
2.2%
1/46 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
Other adverse events
| Measure |
Denosumab
n=46 participants at risk
60 mg denosumab s.c. at baseline and after 6 months
Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months
|
Control
n=44 participants at risk
No treatment
|
|---|---|---|
|
Infections and infestations
Folliculitis
|
6.5%
3/46 • Number of events 3 • 1 year
|
0.00%
0/44 • 1 year
|
|
Infections and infestations
Herpes zoster
|
6.5%
3/46 • Number of events 3 • 1 year
|
0.00%
0/44 • 1 year
|
|
Infections and infestations
Urinary tract infections
|
26.1%
12/46 • Number of events 39 • 1 year
|
11.4%
5/44 • Number of events 19 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
8.7%
4/46 • Number of events 4 • 1 year
|
9.1%
4/44 • Number of events 4 • 1 year
|
|
Endocrine disorders
Hypocalcemia
|
26.1%
12/46 • Number of events 12 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Vascular disorders
Thrombosis
|
2.2%
1/46 • Number of events 1 • 1 year
|
9.1%
4/44 • Number of events 4 • 1 year
|
|
Infections and infestations
Aphtous stomatitis
|
4.3%
2/46 • Number of events 3 • 1 year
|
6.8%
3/44 • Number of events 3 • 1 year
|
|
General disorders
Fever
|
2.2%
1/46 • Number of events 1 • 1 year
|
6.8%
3/44 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.3%
2/46 • Number of events 3 • 1 year
|
9.1%
4/44 • Number of events 4 • 1 year
|
|
Infections and infestations
Sore throat
|
8.7%
4/46 • Number of events 4 • 1 year
|
11.4%
5/44 • Number of events 5 • 1 year
|
|
Nervous system disorders
Tremor
|
4.3%
2/46 • Number of events 2 • 1 year
|
15.9%
7/44 • Number of events 7 • 1 year
|
|
Skin and subcutaneous tissue disorders
Exanthema
|
13.0%
6/46 • Number of events 6 • 1 year
|
9.1%
4/44 • Number of events 4 • 1 year
|
|
General disorders
Headache
|
8.7%
4/46 • Number of events 4 • 1 year
|
6.8%
3/44 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
8.7%
4/46 • Number of events 4 • 1 year
|
6.8%
3/44 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck/back pain
|
10.9%
5/46 • Number of events 8 • 1 year
|
6.8%
3/44 • Number of events 3 • 1 year
|
|
General disorders
Rhinorrhea
|
0.00%
0/46 • 1 year
|
6.8%
3/44 • Number of events 3 • 1 year
|
|
Infections and infestations
Oral candidiasis
|
6.5%
3/46 • Number of events 6 • 1 year
|
6.8%
3/44 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.5%
3/46 • Number of events 3 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
General disorders
Alopecia
|
6.5%
3/46 • Number of events 3 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
10.9%
5/46 • Number of events 7 • 1 year
|
4.5%
2/44 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Fecal blood
|
6.5%
3/46 • Number of events 3 • 1 year
|
0.00%
0/44 • 1 year
|
|
General disorders
Edema
|
10.9%
5/46 • Number of events 6 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Dysuria
|
8.7%
4/46 • Number of events 5 • 1 year
|
0.00%
0/44 • 1 year
|
Additional Information
Prof. Rudolf P. Wüthrich
University Hospital Zürich
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place