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NCT00580788 · OUTCOME

Fractional Excretion of 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
% of filtered load
Interval / dispersion
Standard Error
Time frame
daily

What was measured

% calculated from daily second morning void

Groups in this outcome

Group 1

PTHrP(1-36) 2 picomoles/kg/hr for one week.

Group 2

PTHrP(1-36) 4 picomoles/kg/hr for one week

Group 3

PTHrP(1-36) 5 picomoles/kg/hr for one week

Group 4

PTHrP(1-36) 6 picomoles/kg/hr for one week

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

Analysis denominator · Participants

GroupSource count
Group 13
Group 26
Group 33
Group 40

Reported measurements

Baseline
Values in % of filtered load · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group 11.930.91Not reportedNot reportedNot reported
Group 22.570.73Not reportedNot reportedNot reported
Group 32.380.59Not reportedNot reportedNot reported
Day 2
Values in % of filtered load · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group 11.310.59Not reportedNot reportedNot reported
Group 22.260.46Not reportedNot reportedNot reported
Group 34.112.42Not reportedNot reportedNot reported
Day 3
Values in % of filtered load · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group 11.070.51Not reportedNot reportedNot reported
Group 22.850.61Not reportedNot reportedNot reported
Group 33.270.45Not reportedNot reportedNot reported
Day 4
Values in % of filtered load · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group 11.570.25Not reportedNot reportedNot reported
Group 22.790.76Not reportedNot reportedNot reported
Group 32.140.40Not reportedNot reportedNot reported
Day 5
Values in % of filtered load · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group 13.050.70Not reportedNot reportedNot reported
Group 22.050.46Not reportedNot reportedNot reported
Group 33.120.46Not reportedNot reportedNot reported
Day 6
Values in % of filtered load · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group 13.370.67Not reportedNot reportedNot reported
Group 22.750.25Not reportedNot reportedNot reported
Group 35.422.23Not reportedNot reportedNot reported
Day 7
Values in % of filtered load · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Group 12.720.28Not reportedNot reportedNot reported
Group 23.940.38Not reportedNot reportedNot reported
Group 34.130.73Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. 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
    .002
    p Value Comment
    the reported p-value corresponds to the increase comapred to baseline over time (days 2-8) in the PTHrP 4 pmol group
    statistical Comment
    The level of statistical significance was set at .05 (two-tailed)
    statistical Method
    Mixed Models Analysis
    tested Non Inferiority
    true
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. 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
    .002
    p Value Comment
    the reported p-value corresponds to the increase comapred to baseline over time (days 2-8) in the PTHrP 4 pmol group
    statistical Comment
    The level of statistical significance was set at .05 (two-tailed)
    statistical Method
    Mixed Models Analysis
    tested Non Inferiority
    true
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.91
        value
        1.93
      2. group Id
        OG001
        spread
        0.73
        value
        2.57
      3. group Id
        OG002
        spread
        0.59
        value
        2.38
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.59
        value
        1.31
      2. group Id
        OG001
        spread
        0.46
        value
        2.26
      3. group Id
        OG002
        spread
        2.42
        value
        4.11
    title
    Day 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.51
        value
        1.07
      2. group Id
        OG001
        spread
        0.61
        value
        2.85
      3. group Id
        OG002
        spread
        0.45
        value
        3.27
    title
    Day 3
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.25
        value
        1.57
      2. group Id
        OG001
        spread
        0.76
        value
        2.79
      3. group Id
        OG002
        spread
        0.40
        value
        2.14
    title
    Day 4
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.70
        value
        3.05
      2. group Id
        OG001
        spread
        0.46
        value
        2.05
      3. group Id
        OG002
        spread
        0.46
        value
        3.12
    title
    Day 5
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.67
        value
        3.37
      2. group Id
        OG001
        spread
        0.25
        value
        2.75
      3. group Id
        OG002
        spread
        2.23
        value
        5.42
    title
    Day 6
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.28
        value
        2.72
      2. group Id
        OG001
        spread
        0.38
        value
        3.94
      3. group Id
        OG002
        spread
        0.73
        value
        4.13
    title
    Day 7
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      0
    units
    Participants
description
% calculated from daily second morning void
dispersion Type
Standard Error
groups
  1. description
    PTHrP(1-36) 2 picomoles/kg/hr for one week.
    id
    OG000
    title
    Group 1
  2. description
    PTHrP(1-36) 4 picomoles/kg/hr for one week
    id
    OG001
    title
    Group 2
  3. description
    PTHrP(1-36) 5 picomoles/kg/hr for one week
    id
    OG002
    title
    Group 3
  4. description
    PTHrP(1-36) 6 picomoles/kg/hr for one week
    id
    OG003
    title
    Group 4
param Type
MEAN
reporting Status
POSTED
time Frame
daily
title
Fractional Excretion of Calcium
type
SECONDARY
unit Of Measure
% of filtered load

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Preserved source evidence · Not medical advice