Trial Outcomes & Findings for Long-Term Retention of Gadolinium in Bone (NCT NCT01853163)
NCT ID: NCT01853163
Last Updated: 2022-09-28
Results Overview
Concentration of total Gd in trabecular bone determined by ICP-MS
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
Day 0 (visit 2, surgery); optional visit 6 (second surgery)
Results posted on
2022-09-28
Participant Flow
Study sample size was decreased on the basis of protocol amendment #2 date 26 FEB 2016.
Participant milestones
| Measure |
GBCA Exposure Group - Normal Renal Function.
Patients with normal renal function (eGFR \> 60 ml/min /1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function.
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function.
GBCA naive patients with normal renal function (eGFR \> 60 ml/min /1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function.
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
29
|
7
|
11
|
|
Overall Study
COMPLETED
|
45
|
29
|
7
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
GBCA Exposure Group - Normal Renal Function.
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min /1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function.
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function.
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function.
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 10.5 • n=45 Participants
|
74.6 years
STANDARD_DEVIATION 7.37 • n=29 Participants
|
70 years
STANDARD_DEVIATION 10.88 • n=7 Participants
|
78.4 years
STANDARD_DEVIATION 5.28 • n=11 Participants
|
69.5 years
STANDARD_DEVIATION 10.65 • n=92 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=45 Participants
|
20 Participants
n=29 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=11 Participants
|
52 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=45 Participants
|
9 Participants
n=29 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=11 Participants
|
40 Participants
n=92 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Height
|
164.1 cm
STANDARD_DEVIATION 11.08 • n=45 Participants
|
158.9 cm
STANDARD_DEVIATION 9.83 • n=29 Participants
|
174 cm
STANDARD_DEVIATION 5.86 • n=7 Participants
|
162.6 cm
STANDARD_DEVIATION 7.58 • n=11 Participants
|
163 cm
STANDARD_DEVIATION 10.63 • n=92 Participants
|
|
Weight
|
76 kg
STANDARD_DEVIATION 21.09 • n=45 Participants
|
66.7 kg
STANDARD_DEVIATION 19.01 • n=29 Participants
|
90 kg
STANDARD_DEVIATION 13.08 • n=7 Participants
|
76.6 kg
STANDARD_DEVIATION 14.86 • n=11 Participants
|
74.2 kg
STANDARD_DEVIATION 20.03 • n=92 Participants
|
PRIMARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Population: Note: Below values for both control groups (0 (0%)) are "NA = Descriptive statistics not performed since it does not satisfy 2/3 of GBCA concentration values are available and above BLQ", 2 patients of the control group with impaired renal function have values \> BLQ, max 1.921 ug/g.
Concentration of total Gd in trabecular bone determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentration of Total Gadolinium in Trabecular Bone
|
0.335 micrograms/gram
Geometric Coefficient of Variation 476.7
|
0.783 micrograms/gram
Geometric Coefficient of Variation 413.8
|
0 micrograms/gram
Geometric Coefficient of Variation 0
|
0 micrograms/gram
Geometric Coefficient of Variation 0
|
PRIMARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Population: Note: Below values for both control groups (0 (0%)) are "NA = Descriptive statistics not performed since it does not satisfy 2/3 of GBCA concentration values are available and above BLQ", 2 patients of the control group with impaired renal function have values \> BLQ, max 1.095 ug/g)
Concentration of total Gd in cortical bone determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentration of Total Gadolinium in Cortical Bone
|
0.298 micrograms/gram
Geometric Coefficient of Variation 467.5
|
0.680 micrograms/gram
Geometric Coefficient of Variation 410.3
|
0 micrograms/gram
Geometric Coefficient of Variation 0
|
0 micrograms/gram
Geometric Coefficient of Variation 0
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Population: Note: Below values for all groups (0 (0%)) are "NA = Descriptive statistics not performed since it does not satisfy 2/3 of GBCA concentration values are available and above BLQ", 1 patient of the control group with impaired renal function has a value \> BLQ, max 0.138 ug/g.
Concentration of total Gd in skin tissue samples (determined by ICP-MS (inductively coupled plasma mass spectrometry)), collected at the time of the scheduled orthopaedic surgical procedure, from a biopsy from the edge of the surgical wound or the amputated part. Analysation of a single skin tissue sample; in case of a second surgery a further sample was taken.
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentration of Total Gd in Skin Tissue Samples
|
0 micrograms/gram
Geometric Coefficient of Variation 0
|
0 micrograms/gram
Geometric Coefficient of Variation 0
|
0 micrograms/gram
Geometric Coefficient of Variation 0
|
0 micrograms/gram
Geometric Coefficient of Variation 0
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentration of calcium in skin tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentration of Calcium in Skin Tissue Samples
|
653.268 micrograms/gram
Geometric Coefficient of Variation 65.9
|
651.478 micrograms/gram
Geometric Coefficient of Variation 55.6
|
474.377 micrograms/gram
Geometric Coefficient of Variation 78.8
|
790.700 micrograms/gram
Geometric Coefficient of Variation 105.8
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentration of calcium in cortical bone tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentration of Calcium in Cortical Bone Tissue Samples
|
96908.336 micrograms/gram
Geometric Coefficient of Variation 31.8
|
92491.896 micrograms/gram
Geometric Coefficient of Variation 34
|
142662.680 micrograms/gram
Geometric Coefficient of Variation 11.8
|
118447.534 micrograms/gram
Geometric Coefficient of Variation 25.5
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentrations of phosphorus in cortical bone tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentrations of Phosphorus in Cortical Bone Tissue Samples
|
52361.735 micrograms/gram
Geometric Coefficient of Variation 30
|
50247.073 micrograms/gram
Geometric Coefficient of Variation 32.1
|
73151.974 micrograms/gram
Geometric Coefficient of Variation 12.7
|
62689.679 micrograms/gram
Geometric Coefficient of Variation 21.6
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentrations of sodium in cortical bone tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentrations of Sodium in Cortical Bone Tissue Samples
|
5642.001 micrograms/gram
Geometric Coefficient of Variation 22.3
|
5768.821 micrograms/gram
Geometric Coefficient of Variation 19.2
|
5437.226 micrograms/gram
Geometric Coefficient of Variation 15.6
|
5511.498 micrograms/gram
Geometric Coefficient of Variation 28.2
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentrations of zinc in cortical bone tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentrations of Zinc in Bone Tissue Samples (Cortical)
|
78.516 micrograms/gram
Geometric Coefficient of Variation 29
|
79.900 micrograms/gram
Geometric Coefficient of Variation 24.7
|
92.622 micrograms/gram
Geometric Coefficient of Variation 12.1
|
89.539 micrograms/gram
Geometric Coefficient of Variation 19.1
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentration of potassium in bone (cortical) tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentration of Potassium in Cortical Bone Tissue Samples
|
488.128 micrograms/gram
Geometric Coefficient of Variation 41.5
|
543.211 micrograms/gram
Geometric Coefficient of Variation 61.9
|
541.822 micrograms/gram
Geometric Coefficient of Variation 51.1
|
426.705 micrograms/gram
Geometric Coefficient of Variation 65.4
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentrations of iron in bone (cortical) tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentrations of Iron in Cortical Bone Tissue Samples
|
38.807 micrograms/gram
Geometric Coefficient of Variation 71.9
|
41.116 micrograms/gram
Geometric Coefficient of Variation 118.9
|
57.069 micrograms/gram
Geometric Coefficient of Variation 88.5
|
32.293 micrograms/gram
Geometric Coefficient of Variation 109.8
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentrations of calcium in trabecular bone tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentration of Calcium in Trabecular Bone Tissue Samples
|
124671.921 micrograms/gram
Geometric Coefficient of Variation 22.2
|
116601.987 micrograms/gram
Geometric Coefficient of Variation 24.2
|
145859.369 micrograms/gram
Geometric Coefficient of Variation 20.3
|
143735.414 micrograms/gram
Geometric Coefficient of Variation 11.5
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentrations of phosphorus in bone (trabecular) tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentration of Phosphorus in Trabecular Bone Tissue Samples
|
65887.298 micrograms/gram
Geometric Coefficient of Variation 17.7
|
62333.483 micrograms/gram
Geometric Coefficient of Variation 18.4
|
74988.227 micrograms/gram
Geometric Coefficient of Variation 20.8
|
74435.230 micrograms/gram
Geometric Coefficient of Variation 11.7
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentrations of sodium in trabecular bone tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentrations of Sodium in Trabecular Bone Tissue Samples
|
4743.199 micrograms/gram
Geometric Coefficient of Variation 19.7
|
4514.245 micrograms/gram
Geometric Coefficient of Variation 19.5
|
4681.874 micrograms/gram
Geometric Coefficient of Variation 13.8
|
4580.294 micrograms/gram
Geometric Coefficient of Variation 14.7
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentrations of zinc in trabecular bone tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentrations of Zinc in Trabecular Bone Tissue Samples
|
83.812 micrograms/gram
Geometric Coefficient of Variation 29
|
85.312 micrograms/gram
Geometric Coefficient of Variation 30.2
|
89.849 micrograms/gram
Geometric Coefficient of Variation 15.4
|
93.524 micrograms/gram
Geometric Coefficient of Variation 18.3
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentrations of potassium in trabecular bone tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=42 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=25 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=6 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=9 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentrations of Potassium in Trabecular Bone Tissue Samples
|
394.953 micrograms/gram
Geometric Coefficient of Variation 57.2
|
461.425 micrograms/gram
Geometric Coefficient of Variation 81.9
|
679.490 micrograms/gram
Geometric Coefficient of Variation 85.8
|
340.698 micrograms/gram
Geometric Coefficient of Variation 48.6
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentrations of iron in trabecular bone tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentrations of Iron in Trabecular Bone Tissue Samples
|
40.142 micrograms/gram
Geometric Coefficient of Variation 96.8
|
42.889 micrograms/gram
Geometric Coefficient of Variation 116.9
|
62.371 micrograms/gram
Geometric Coefficient of Variation 180.5
|
23.709 micrograms/gram
Geometric Coefficient of Variation 68.7
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentrations of phosphorus in skin tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentrations of Phosphorus in Skin Tissue Samples
|
1023.978 micrograms/gram
Geometric Coefficient of Variation 36.9
|
1038.525 micrograms/gram
Geometric Coefficient of Variation 32.2
|
1075.359 micrograms/gram
Geometric Coefficient of Variation 34.1
|
1129.268 micrograms/gram
Geometric Coefficient of Variation 52.7
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentrations of sodium in skin tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentrations of Sodium in Skin Tissue Samples
|
3711.129 micrograms/gram
Geometric Coefficient of Variation 42.5
|
4146.187 micrograms/gram
Geometric Coefficient of Variation 49.9
|
4660.517 micrograms/gram
Geometric Coefficient of Variation 36.6
|
4871.197 micrograms/gram
Geometric Coefficient of Variation 42.9
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentrations of zinc in skin tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentrations of Zinc in Skin Tissue Samples
|
24.639 micrograms/gram
Geometric Coefficient of Variation 59.5
|
28.767 micrograms/gram
Geometric Coefficient of Variation 55.7
|
27.692 micrograms/gram
Geometric Coefficient of Variation 112.3
|
23.537 micrograms/gram
Geometric Coefficient of Variation 32.9
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentration of potassium in skin tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentration of Potassium in Skin Tissue Samples
|
1011.939 micrograms/gram
Geometric Coefficient of Variation 41.7
|
1132.855 micrograms/gram
Geometric Coefficient of Variation 45.1
|
1418.726 micrograms/gram
Geometric Coefficient of Variation 31.8
|
1121.846 micrograms/gram
Geometric Coefficient of Variation 34.4
|
SECONDARY outcome
Timeframe: Day 0 (visit 2, surgery); optional visit 6 (second surgery)Concentration of iron in skin tissue samples determined by ICP-MS
Outcome measures
| Measure |
GBCA Exposure Group - Normal Renal Function
n=45 Participants
Patients with normal renal function (eGFR \> 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Exposure Group - Impaired Renal Function
n=29 Participants
Patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2) who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive - Control Group With Normal Renal Function
n=7 Participants
GBCA naive patients with normal renal function (eGFR \> 60 ml/min/1.73 m2)
|
GBCA Naive - Control Group With Impaired Renal Function
n=11 Participants
GBCA naive patients with impaired renal function (eGFR ≤ 60 ml/min/1.73 m2)
|
|---|---|---|---|---|
|
Concentration of Iron in Skin Tissue Samples
|
69.452 micrograms/gram
Geometric Coefficient of Variation 86.4
|
103.432 micrograms/gram
Geometric Coefficient of Variation 101.8
|
145.362 micrograms/gram
Geometric Coefficient of Variation 36.4
|
99.477 micrograms/gram
Geometric Coefficient of Variation 79.2
|
Adverse Events
GBCA Exposure Group
Serious events: 3 serious events
Other events: 35 other events
Deaths: 2 deaths
GBCA Naive Control Group
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GBCA Exposure Group
n=74 participants at risk
Patients who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive Control Group
n=18 participants at risk
GBCA naive patients
|
|---|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.4%
1/74 • Number of events 1 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
0.00%
0/18 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Injury, poisoning and procedural complications
Overdose
|
1.4%
1/74 • Number of events 1 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
0.00%
0/18 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.4%
1/74 • Number of events 1 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
0.00%
0/18 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Skin and subcutaneous tissue disorders
Nephrogenic Systemic Fibrosis
|
0.00%
0/74 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
0.00%
0/18 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/74 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
5.6%
1/18 • Number of events 1 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/74 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
5.6%
1/18 • Number of events 1 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/74 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
5.6%
1/18 • Number of events 1 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
Other adverse events
| Measure |
GBCA Exposure Group
n=74 participants at risk
Patients who received at least one months prior to the scheduled orthopaedic surgical procedure one or multiple injections of the same GBCA.
|
GBCA Naive Control Group
n=18 participants at risk
GBCA naive patients
|
|---|---|---|
|
Cardiac disorders
Cardiac disorder
|
1.4%
1/74 • Number of events 2 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
5.6%
1/18 • Number of events 1 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
17.6%
13/74 • Number of events 15 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
11.1%
2/18 • Number of events 2 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
General disorders
General Disorders And Administration
|
10.8%
8/74 • Number of events 10 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
5.6%
1/18 • Number of events 1 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Infections and infestations
Infections And Infestations
|
6.8%
5/74 • Number of events 6 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
11.1%
2/18 • Number of events 2 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Injury, poisoning and procedural complications
Injury, Poisoning And Procedural Complications
|
16.2%
12/74 • Number of events 13 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
22.2%
4/18 • Number of events 4 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Investigations
Investigations
|
6.8%
5/74 • Number of events 20 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
0.00%
0/18 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders
|
5.4%
4/74 • Number of events 5 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
0.00%
0/18 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorders
|
12.2%
9/74 • Number of events 10 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
0.00%
0/18 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Nervous system disorders
Nervous System Disorders
|
2.7%
2/74 • Number of events 2 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
5.6%
1/18 • Number of events 1 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Psychiatric disorders
Psychiatric Disorders
|
14.9%
11/74 • Number of events 12 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
16.7%
3/18 • Number of events 3 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Renal and urinary disorders
Renal And Urinary Disorders
|
2.7%
2/74 • Number of events 2 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
11.1%
2/18 • Number of events 2 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders
|
2.7%
2/74 • Number of events 3 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
0.00%
0/18 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders
|
6.8%
5/74 • Number of events 5 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
5.6%
1/18 • Number of events 1 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Vascular disorders
Vascular Disorders
|
13.5%
10/74 • Number of events 14 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
11.1%
2/18 • Number of events 2 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders
|
0.00%
0/74 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
11.1%
2/18 • Number of events 3 • Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place