NCT03027557 · BASELINE

Baseline characteristics

Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet. · Source last updated 2021-05-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms

counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants

groups

description
15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.
id
BG000
title
Combined Treatment.
description
16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.
id
BG001
title
Denosumab Monotherapy
description
15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.
id
BG002
title
Placebo
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
13.2
value
65.1
group Id
BG001
spread
8.8
value
65.4
group Id
BG002
spread
7.0
value
68.0
group Id
BG003
spread
9.7
value
66.15
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
13
group Id
BG002
value
12
group Id
BG003
value
39
title
Female
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
3
group Id
BG003
value
7
title
Male
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG003
value
0
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Race and Ethnicity were not collected from any participant.
title
Race and Ethnicity Not Collected
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
title
Denmark
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
spread
0.93
value
-1.9
group Id
BG001
spread
0.68
value
-2.0
group Id
BG002
spread
0.85
value
-1.3
group Id
BG003
spread
0.87
value
-1.7
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Baseline Bone mineral density (BMD) at lumbar spine (L2-L4) T-score. The T-score is the number of units that the bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates osteoporosis
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
T-score Lumbar Spine (LS) by Dual X-ray Absorptiometry (DXA)
unit Of Measure
T-score
classes
categories
measurements
group Id
BG000
spread
0.5
value
-1.4
group Id
BG001
spread
0.6
value
-1.4
group Id
BG002
spread
0.5
value
-1.1
group Id
BG003
spread
0.5
value
-1.3
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Baseline Bone mineral density (BMD) at Total Hip (TH) T-score. The T-score is the number of units that the bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates osteoporosis.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
T-score TH (by DXA)
unit Of Measure
T-score
classes
categories
measurements
group Id
BG000
spread
0.7
value
-2.0
group Id
BG001
spread
0.7
value
-1.9
group Id
BG002
spread
0.6
value
-1.7
group Id
BG003
spread
0.6
value
-1.88
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Baseline Bone mineral density (BMD) at Femoral Neck (FN) T-score. The T-score is the number of units that the bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates osteoporosis.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
T-score FN (by DXA)
unit Of Measure
T-score
classes
categories
measurements
group Id
BG000
spread
1.2
value
-2.4
group Id
BG001
spread
1.2
value
-2.4
group Id
BG002
spread
0.9
value
-2.8
group Id
BG003
spread
1.1
value
-2.5
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Baseline Bone mineral density (BMD) at 1/3 distal forearm (1/3 FA)T-score. The T-score is the number of units that the bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates osteoporosis.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
T-score 1/3 FA (by DXA)
unit Of Measure
T-score
classes
categories
measurements
group Id
BG000
spread
28.1
value
96.4
group Id
BG001
spread
24.0
value
99.7
group Id
BG002
spread
25.4
value
94.2
group Id
BG003
spread
25.1
value
96.9
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Baseline lumbar spine BMD by quantitative computed tomography (QCT)
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Volumetric Bone Mineral Density (vBMD) LS
unit Of Measure
mg/cm^3
classes
categories
measurements
group Id
BG000
spread
32.0
value
183.5
group Id
BG001
spread
37.6
value
194.9
group Id
BG002
spread
35.5
value
181.4
group Id
BG003
spread
34.6
value
192.6
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Bone Mineral Density at the distal forearm by QCT
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
vBMD distal forearm
unit Of Measure
mg/cm^3
classes
categories
measurements
group Id
BG000
spread
0.5
value
1.23
group Id
BG001
spread
0.5
value
1.19
group Id
BG002
spread
0.4
value
1.14
group Id
BG003
spread
0.4
value
1.2
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Baseline cortical Width of the distal forearm.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Cortical width
unit Of Measure
mm
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
1
group Id
BG003
value
4
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Subjects with nephrolithiasis at baseline
param Type
COUNT_OF_PARTICIPANTS
title
Nephrolithiasis
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants

groups

description
15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.
id
BG000
title
Combined Treatment.
description
16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.
id
BG001
title
Denosumab Monotherapy
description
15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.
id
BG002
title
Placebo
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
13.2
value
65.1
group Id
BG001
spread
8.8
value
65.4
group Id
BG002
spread
7.0
value
68.0
group Id
BG003
spread
9.7
value
66.15
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
13
group Id
BG002
value
12
group Id
BG003
value
39
title
Female
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
3
group Id
BG003
value
7
title
Male
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG003
value
0
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Race and Ethnicity were not collected from any participant.
title
Race and Ethnicity Not Collected
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
title
Denmark
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
spread
0.93
value
-1.9
group Id
BG001
spread
0.68
value
-2.0
group Id
BG002
spread
0.85
value
-1.3
group Id
BG003
spread
0.87
value
-1.7
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Baseline Bone mineral density (BMD) at lumbar spine (L2-L4) T-score. The T-score is the number of units that the bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates osteoporosis
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
T-score Lumbar Spine (LS) by Dual X-ray Absorptiometry (DXA)
unit Of Measure
T-score
classes
categories
measurements
group Id
BG000
spread
0.5
value
-1.4
group Id
BG001
spread
0.6
value
-1.4
group Id
BG002
spread
0.5
value
-1.1
group Id
BG003
spread
0.5
value
-1.3
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Baseline Bone mineral density (BMD) at Total Hip (TH) T-score. The T-score is the number of units that the bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates osteoporosis.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
T-score TH (by DXA)
unit Of Measure
T-score
classes
categories
measurements
group Id
BG000
spread
0.7
value
-2.0
group Id
BG001
spread
0.7
value
-1.9
group Id
BG002
spread
0.6
value
-1.7
group Id
BG003
spread
0.6
value
-1.88
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Baseline Bone mineral density (BMD) at Femoral Neck (FN) T-score. The T-score is the number of units that the bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates osteoporosis.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
T-score FN (by DXA)
unit Of Measure
T-score
classes
categories
measurements
group Id
BG000
spread
1.2
value
-2.4
group Id
BG001
spread
1.2
value
-2.4
group Id
BG002
spread
0.9
value
-2.8
group Id
BG003
spread
1.1
value
-2.5
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Baseline Bone mineral density (BMD) at 1/3 distal forearm (1/3 FA)T-score. The T-score is the number of units that the bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates osteoporosis.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
T-score 1/3 FA (by DXA)
unit Of Measure
T-score
classes
categories
measurements
group Id
BG000
spread
28.1
value
96.4
group Id
BG001
spread
24.0
value
99.7
group Id
BG002
spread
25.4
value
94.2
group Id
BG003
spread
25.1
value
96.9
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Baseline lumbar spine BMD by quantitative computed tomography (QCT)
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Volumetric Bone Mineral Density (vBMD) LS
unit Of Measure
mg/cm^3
classes
categories
measurements
group Id
BG000
spread
32.0
value
183.5
group Id
BG001
spread
37.6
value
194.9
group Id
BG002
spread
35.5
value
181.4
group Id
BG003
spread
34.6
value
192.6
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Bone Mineral Density at the distal forearm by QCT
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
vBMD distal forearm
unit Of Measure
mg/cm^3
classes
categories
measurements
group Id
BG000
spread
0.5
value
1.23
group Id
BG001
spread
0.5
value
1.19
group Id
BG002
spread
0.4
value
1.14
group Id
BG003
spread
0.4
value
1.2
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Baseline cortical Width of the distal forearm.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Cortical width
unit Of Measure
mm
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
1
group Id
BG003
value
4
denoms
counts
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
15
group Id
BG003
value
46
units
Participants
description
Subjects with nephrolithiasis at baseline
param Type
COUNT_OF_PARTICIPANTS
title
Nephrolithiasis
unit Of Measure
Participants

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Preserved source evidence · Not medical advice