NCT00580788 · OUTCOME
Bone Specific Alkaline Phosphatase (BSAP)
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 | -12.53 | 8.60 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -1.17 | 4.10 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 24.54 | 7.01 | Not reported | Not reported | Not reported |
|---|
Day 3
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -6.35 | 4.84 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -1.44 | 3.07 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 34.77 | 6.53 | Not reported | Not reported | Not reported |
|---|
Day 4
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -5.82 | 1.58 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -3.79 | 4.65 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 19.49 | 8.23 | Not reported | Not reported | Not reported |
|---|
Day 5
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -0.33 | 0.33 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -9.64 | 4.73 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 13.61 | 9.76 | Not reported | Not reported | Not reported |
|---|
Day 6
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -8.16 | 9.32 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -10.88 | 4.04 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 9.02 | 8.94 | Not reported | Not reported | Not reported |
|---|
Day 7
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -11.91 | 10.38 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -16.78 | 2.58 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 9.86 | 4.01 | Not reported | Not reported | Not reported |
|---|
Day 8
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -7.80 | 8.66 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -14.01 | 3.72 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 15.27 | 11.63 | Not reported | Not reported | Not reported |
|---|
follow-up
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -1.25 | 2.70 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 6.16 | 3.81 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 18.23 | 2.22 | 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
- 0.001
- p Value Comment
- the reported p-value correspond to the decrease compared to baseline over time 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
- 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
- .01
- p Value Comment
- the reported p=value corresponds to % change compared to baseline at follow-up 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
- 0.001
- p Value Comment
- the reported p-value correspond to the decrease compared to baseline over time 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
- 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
- .01
- p Value Comment
- the reported p=value corresponds to % change compared to baseline at follow-up 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
- 8.60
- value
- -12.53
- group Id
- OG001
- spread
- 4.10
- value
- -1.17
- group Id
- OG002
- spread
- 7.01
- value
- 24.54
- title
- Day 2
- categories
- measurements
- group Id
- OG000
- spread
- 4.84
- value
- -6.35
- group Id
- OG001
- spread
- 3.07
- value
- -1.44
- group Id
- OG002
- spread
- 6.53
- value
- 34.77
- title
- Day 3
- categories
- measurements
- group Id
- OG000
- spread
- 1.58
- value
- -5.82
- group Id
- OG001
- spread
- 4.65
- value
- -3.79
- group Id
- OG002
- spread
- 8.23
- value
- 19.49
- title
- Day 4
- categories
- measurements
- group Id
- OG000
- spread
- 0.33
- value
- -0.33
- group Id
- OG001
- spread
- 4.73
- value
- -9.64
- group Id
- OG002
- spread
- 9.76
- value
- 13.61
- title
- Day 5
- categories
- measurements
- group Id
- OG000
- spread
- 9.32
- value
- -8.16
- group Id
- OG001
- spread
- 4.04
- value
- -10.88
- group Id
- OG002
- spread
- 8.94
- value
- 9.02
- title
- Day 6
- categories
- measurements
- group Id
- OG000
- spread
- 10.38
- value
- -11.91
- group Id
- OG001
- spread
- 2.58
- value
- -16.78
- group Id
- OG002
- spread
- 4.01
- value
- 9.86
- title
- Day 7
- categories
- measurements
- group Id
- OG000
- spread
- 8.66
- value
- -7.80
- group Id
- OG001
- spread
- 3.72
- value
- -14.01
- group Id
- OG002
- spread
- 11.63
- value
- 15.27
- title
- Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 2.70
- value
- -1.25
- group Id
- OG001
- spread
- 3.81
- value
- 6.16
- group Id
- OG002
- spread
- 2.22
- value
- 18.23
- 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
- Bone Specific Alkaline Phosphatase (BSAP)
- type
- SECONDARY
- unit Of Measure
- % change
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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