NCT00580788 · OUTCOME

Total Serum Calcium

One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study · Source last updated 2016-02-11

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

Measure: MEAN
Unit: mg/dl
Interval / dispersion: Standard Error
Time frame: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete

What was measured

mg/dl

Groups in this outcome

Group 1

PTHrP(1-36) 2 picomoles/kg/hr

Group 2

PTHrP(1-36) 4 picomoles/kg/hr

Group 3

PTHrP (1-36) 5 pmol/kg/hr

Group 4

PTHrP (1-36) 6 picomoles/kg/hr

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Group 1	3
Group 2	6
Group 3	3
Group 4	0

Reported measurements

baseline

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.37	0.07	Not reported	Not reported	Not reported
Group 2	9.58	0.12	Not reported	Not reported	Not reported
Group 3	9.2	0.25	Not reported	Not reported	Not reported

11P DAY 1

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.67	0.09	Not reported	Not reported	Not reported
Group 2	9.80	0.16	Not reported	Not reported	Not reported
Group 3	9.67	0.20	Not reported	Not reported	Not reported

7A DAY 2

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.4	0.17	Not reported	Not reported	Not reported
Group 2	10.05	0.19	Not reported	Not reported	Not reported
Group 3	10.17	0.20	Not reported	Not reported	Not reported

3P DAY 2

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.57	0.09	Not reported	Not reported	Not reported
Group 2	10.28	0.14	Not reported	Not reported	Not reported
Group 3	10.47	0.30	Not reported	Not reported	Not reported

11P DAY 2

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.67	0.09	Not reported	Not reported	Not reported
Group 2	10.32	0.14	Not reported	Not reported	Not reported
Group 3	10.23	0.26	Not reported	Not reported	Not reported

7A DAY 3

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.6	0.10	Not reported	Not reported	Not reported
Group 2	10.40	0.18	Not reported	Not reported	Not reported
Group 3	10.73	0.57	Not reported	Not reported	Not reported

3P DAY 3

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.73	0.09	Not reported	Not reported	Not reported
Group 2	10.42	0.14	Not reported	Not reported	Not reported
Group 3	10.67	0.27	Not reported	Not reported	Not reported

11P DAY 3

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.40	0.17	Not reported	Not reported	Not reported
Group 2	9.73	0.10	Not reported	Not reported	Not reported
Group 3	9.93	0.38	Not reported	Not reported	Not reported

7A DAY 4

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.47	0.03	Not reported	Not reported	Not reported
Group 2	10.00	0.24	Not reported	Not reported	Not reported
Group 3	10.3	0.23	Not reported	Not reported	Not reported

3P DAY 4

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.40	0.17	Not reported	Not reported	Not reported
Group 2	9.92	0.21	Not reported	Not reported	Not reported
Group 3	10.33	0.34	Not reported	Not reported	Not reported

11P DAY 4

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.37	0.09	Not reported	Not reported	Not reported
Group 2	9.48	0.11	Not reported	Not reported	Not reported
Group 3	10.00	0.15	Not reported	Not reported	Not reported

7A DAY 5

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.30	0.12	Not reported	Not reported	Not reported
Group 2	9.62	0.12	Not reported	Not reported	Not reported
Group 3	10.53	0.15	Not reported	Not reported	Not reported

3P DAY 5

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.50	0.15	Not reported	Not reported	Not reported
Group 2	9.83	0.20	Not reported	Not reported	Not reported
Group 3	10.27	0.44	Not reported	Not reported	Not reported

11P DAY 5

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.43	0.09	Not reported	Not reported	Not reported
Group 2	9.45	0.13	Not reported	Not reported	Not reported
Group 3	9.80	0.20	Not reported	Not reported	Not reported

7A DAY 6

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.57	0.07	Not reported	Not reported	Not reported
Group 2	9.83	0.20	Not reported	Not reported	Not reported
Group 3	10.53	0.22	Not reported	Not reported	Not reported

3P DAY 6

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.43	0.15	Not reported	Not reported	Not reported
Group 2	10.08	0.12	Not reported	Not reported	Not reported
Group 3	10.83	0.27	Not reported	Not reported	Not reported

11P DAY 6

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.43	0.13	Not reported	Not reported	Not reported
Group 2	9.67	0.21	Not reported	Not reported	Not reported
Group 3	10.43	0.47	Not reported	Not reported	Not reported

7A DAY 7

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.40	0.10	Not reported	Not reported	Not reported
Group 2	10.13	0.28	Not reported	Not reported	Not reported
Group 3	10.90	0.46	Not reported	Not reported	Not reported

3P DAY 7

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.70	0.15	Not reported	Not reported	Not reported
Group 2	10.22	0.32	Not reported	Not reported	Not reported
Group 3	10.70	0.46	Not reported	Not reported	Not reported

11P DAY 7

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.60	0.15	Not reported	Not reported	Not reported
Group 2	10.27	0.28	Not reported	Not reported	Not reported
Group 3	10.73	0.50	Not reported	Not reported	Not reported

7A DAY 8

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.83	0.13	Not reported	Not reported	Not reported
Group 2	10.67	0.40	Not reported	Not reported	Not reported
Group 3	11.17	0.35	Not reported	Not reported	Not reported

FOLLOW-UP

Values in mg/dl · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group 1	9.33	0.07	Not reported	Not reported	Not reported
Group 2	9.80	0.12	Not reported	Not reported	Not reported
Group 3	9.17	0.24	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Num Sides
TWO_SIDED
group Ids
OG001
non Inferiority Comment
The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
non Inferiority Type
NON_INFERIORITY_OR_EQUIVALENCE
p Value
<0.0001
p Value Comment
The reported p-value corresponds to the increase over time for the PTHrP 4 pmol group.
statistical Comment
Value The level of statistical significance was set at .05 (two-tailed)
statistical Method
Mixed Models Analysis
tested Non Inferiority
true

Complete source fields

analyses

ci Num Sides
TWO_SIDED
group Ids
OG001
non Inferiority Comment
The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
non Inferiority Type
NON_INFERIORITY_OR_EQUIVALENCE
p Value
<0.0001
p Value Comment
The reported p-value corresponds to the increase over time for the PTHrP 4 pmol group.
statistical Comment
Value The level of statistical significance was set at .05 (two-tailed)
statistical Method
Mixed Models Analysis
tested Non Inferiority
true

classes

categories
measurements
group Id
OG000
spread
0.07
value
9.37
group Id
OG001
spread
0.12
value
9.58
group Id
OG002
spread
0.25
value
9.2
title
baseline
categories
measurements
group Id
OG000
spread
0.09
value
9.67
group Id
OG001
spread
0.16
value
9.80
group Id
OG002
spread
0.20
value
9.67
title
11P DAY 1
categories
measurements
group Id
OG000
spread
0.17
value
9.4
group Id
OG001
spread
0.19
value
10.05
group Id
OG002
spread
0.20
value
10.17
title
7A DAY 2
categories
measurements
group Id
OG000
spread
0.09
value
9.57
group Id
OG001
spread
0.14
value
10.28
group Id
OG002
spread
0.30
value
10.47
title
3P DAY 2
categories
measurements
group Id
OG000
spread
0.09
value
9.67
group Id
OG001
spread
0.14
value
10.32
group Id
OG002
spread
0.26
value
10.23
title
11P DAY 2
categories
measurements
group Id
OG000
spread
0.10
value
9.6
group Id
OG001
spread
0.18
value
10.40
group Id
OG002
spread
0.57
value
10.73
title
7A DAY 3
categories
measurements
group Id
OG000
spread
0.09
value
9.73
group Id
OG001
spread
0.14
value
10.42
group Id
OG002
spread
0.27
value
10.67
title
3P DAY 3
categories
measurements
group Id
OG000
spread
0.17
value
9.40
group Id
OG001
spread
0.10
value
9.73
group Id
OG002
spread
0.38
value
9.93
title
11P DAY 3
categories
measurements
group Id
OG000
spread
0.03
value
9.47
group Id
OG001
spread
0.24
value
10.00
group Id
OG002
spread
0.23
value
10.3
title
7A DAY 4
categories
measurements
group Id
OG000
spread
0.17
value
9.40
group Id
OG001
spread
0.21
value
9.92
group Id
OG002
spread
0.34
value
10.33
title
3P DAY 4
categories
measurements
group Id
OG000
spread
0.09
value
9.37
group Id
OG001
spread
0.11
value
9.48
group Id
OG002
spread
0.15
value
10.00
title
11P DAY 4
categories
measurements
group Id
OG000
spread
0.12
value
9.30
group Id
OG001
spread
0.12
value
9.62
group Id
OG002
spread
0.15
value
10.53
title
7A DAY 5

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
6
group Id
OG002
value
3
group Id
OG003
value
0
units
Participants

description

mg/dl

dispersion Type

Standard Error

groups

description
PTHrP(1-36) 2 picomoles/kg/hr
id
OG000
title
Group 1
description
PTHrP(1-36) 4 picomoles/kg/hr
id
OG001
title
Group 2
description
PTHrP (1-36) 5 pmol/kg/hr
id
OG002
title
Group 3
description
PTHrP (1-36) 6 picomoles/kg/hr
id
OG003
title
Group 4

param Type

MEAN

reporting Status

POSTED

time Frame

12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete

title

Total Serum Calcium

type

PRIMARY

unit Of Measure

mg/dl

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Preserved source evidence · Not medical advice