NCT00580788 · OUTCOME
Amino-terminal Peptides of Procollagen 1 (P1NP)
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
- % change
- Interval / dispersion
- Standard Error
- Time frame
- Baseline, Daily, and 1 week follow-up
What was measured
% change from baseline
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
| Group | Source count |
|---|
| Group 1 | 3 |
|---|
| Group 2 | 6 |
|---|
| Group 3 | 3 |
|---|
| Group 4 | 0 |
|---|
Reported measurements
baseline
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 0.00 | 0.00 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 0.00 | 0.00 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 0.00 | 0.00 | Not reported | Not reported | Not reported |
|---|
Day 2
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -1.05 | 4.95 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -17.49 | 5.93 | Not reported | Not reported | Not reported |
|---|
| Group 3 | -23.88 | 6.05 | Not reported | Not reported | Not reported |
|---|
Day 3
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -6.83 | 2.78 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -30.44 | 7.10 | Not reported | Not reported | Not reported |
|---|
| Group 3 | -37.77 | 6.56 | Not reported | Not reported | Not reported |
|---|
Day 4
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -12.16 | 0.57 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -25.66 | 9.55 | Not reported | Not reported | Not reported |
|---|
| Group 3 | -39.44 | 4.46 | Not reported | Not reported | Not reported |
|---|
Day 5
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -5.63 | 2.27 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -21.27 | 8.01 | Not reported | Not reported | Not reported |
|---|
| Group 3 | -45.04 | 3.07 | Not reported | Not reported | Not reported |
|---|
Day 6
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -8.42 | 5.07 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -31.71 | 7.50 | Not reported | Not reported | Not reported |
|---|
| Group 3 | -39.55 | 1.75 | Not reported | Not reported | Not reported |
|---|
Day 7
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -12.59 | 6.17 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -30.98 | 8.87 | Not reported | Not reported | Not reported |
|---|
| Group 3 | -39.88 | 2.78 | Not reported | Not reported | Not reported |
|---|
Day 8
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -16.03 | 5.03 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -36.60 | 9.64 | Not reported | Not reported | Not reported |
|---|
| Group 3 | -38.53 | 3.40 | Not reported | Not reported | Not reported |
|---|
follow-up
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -7.12 | 2.29 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 0.60 | 9.58 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 46.67 | 17.34 | 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
- 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
- <.0001
- p Value Comment
- the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups
- statistical Comment
- The level of statistical significance was set at .05 (two-tailed)
- statistical Method
- Mixed Models Analysis
- tested Non Inferiority
- true
- ci Num Sides
- TWO_SIDED
- 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
- 0.01
- p Value Comment
- the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups
- 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
- ci Num Sides
- TWO_SIDED
- 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
- <.0001
- p Value Comment
- the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups
- statistical Comment
- The level of statistical significance was set at .05 (two-tailed)
- statistical Method
- Mixed Models Analysis
- tested Non Inferiority
- true
- ci Num Sides
- TWO_SIDED
- 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
- 0.01
- p Value Comment
- the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups
- statistical Comment
- 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
- 0.00
- value
- 0.00
- group Id
- OG001
- spread
- 0.00
- value
- 0.00
- group Id
- OG002
- spread
- 0.00
- value
- 0.00
- title
- baseline
- categories
- measurements
- group Id
- OG000
- spread
- 4.95
- value
- -1.05
- group Id
- OG001
- spread
- 5.93
- value
- -17.49
- group Id
- OG002
- spread
- 6.05
- value
- -23.88
- title
- Day 2
- categories
- measurements
- group Id
- OG000
- spread
- 2.78
- value
- -6.83
- group Id
- OG001
- spread
- 7.10
- value
- -30.44
- group Id
- OG002
- spread
- 6.56
- value
- -37.77
- title
- Day 3
- categories
- measurements
- group Id
- OG000
- spread
- 0.57
- value
- -12.16
- group Id
- OG001
- spread
- 9.55
- value
- -25.66
- group Id
- OG002
- spread
- 4.46
- value
- -39.44
- title
- Day 4
- categories
- measurements
- group Id
- OG000
- spread
- 2.27
- value
- -5.63
- group Id
- OG001
- spread
- 8.01
- value
- -21.27
- group Id
- OG002
- spread
- 3.07
- value
- -45.04
- title
- Day 5
- categories
- measurements
- group Id
- OG000
- spread
- 5.07
- value
- -8.42
- group Id
- OG001
- spread
- 7.50
- value
- -31.71
- group Id
- OG002
- spread
- 1.75
- value
- -39.55
- title
- Day 6
- categories
- measurements
- group Id
- OG000
- spread
- 6.17
- value
- -12.59
- group Id
- OG001
- spread
- 8.87
- value
- -30.98
- group Id
- OG002
- spread
- 2.78
- value
- -39.88
- title
- Day 7
- categories
- measurements
- group Id
- OG000
- spread
- 5.03
- value
- -16.03
- group Id
- OG001
- spread
- 9.64
- value
- -36.60
- group Id
- OG002
- spread
- 3.40
- value
- -38.53
- title
- Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 2.29
- value
- -7.12
- group Id
- OG001
- spread
- 9.58
- value
- 0.60
- group Id
- OG002
- spread
- 17.34
- value
- 46.67
- title
- follow-up
- 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
- % change from baseline
- dispersion Type
- Standard Error
- groups
- description
- PTHrP(1-36) 2 picomoles/kg/hr for one week.
- id
- OG000
- title
- Group 1
- description
- PTHrP(1-36) 4 picomoles/kg/hr for one week.
- id
- OG001
- title
- Group 2
- description
- PTHrP(1-36) 5 picomoles/kg/hr for one week.
- id
- OG002
- title
- Group 3
- description
- PTHrP(1-36) 6 picomoles/kg/hr for one week.
- id
- OG003
- title
- Group 4
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Baseline, Daily, and 1 week follow-up
- title
- Amino-terminal Peptides of Procollagen 1 (P1NP)
- type
- SECONDARY
- unit Of Measure
- % change
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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