NCT00580788 · OUTCOME
Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)
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 | 59.78 | 18.14 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 147.12 | 40.72 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 105.06 | 11.54 | Not reported | Not reported | Not reported |
|---|
Day 3
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 66.67 | 32.24 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 180.27 | 44.45 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 148.45 | 36.80 | Not reported | Not reported | Not reported |
|---|
Day 4
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 71.19 | 18.88 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 167.01 | 47.01 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 165.16 | 40.29 | Not reported | Not reported | Not reported |
|---|
Day 5
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 79.39 | 23.89 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 167.27 | 25.30 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 174.58 | 47.26 | Not reported | Not reported | Not reported |
|---|
Day 6
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 74.09 | 26.72 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 239.51 | 49.42 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 230.42 | 54.10 | Not reported | Not reported | Not reported |
|---|
Day 7
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 109.27 | 29.39 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 283.15 | 65.65 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 267.89 | 104.52 | Not reported | Not reported | Not reported |
|---|
Day 8
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 110.61 | 30.92 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 368.31 | 93.63 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 140.58 | 78.58 | Not reported | Not reported | Not reported |
|---|
follow-up
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -35.73 | 11.53 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -8.60 | 11.15 | Not reported | Not reported | Not reported |
|---|
| Group 3 | -41.33 | 20.38 | 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 % change (increase) from baseline in all Arms/groups at Days 2-8.
- 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
- >0.05
- p Value Comment
- The reported p-value corresponds to the % change from 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
- <.0001
- p Value Comment
- The reported p-value corresponds to % change (increase) from baseline in all Arms/groups at Days 2-8.
- 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
- >0.05
- p Value Comment
- The reported p-value corresponds to the % change from 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
- 18.14
- value
- 59.78
- group Id
- OG001
- spread
- 40.72
- value
- 147.12
- group Id
- OG002
- spread
- 11.54
- value
- 105.06
- title
- Day 2
- categories
- measurements
- group Id
- OG000
- spread
- 32.24
- value
- 66.67
- group Id
- OG001
- spread
- 44.45
- value
- 180.27
- group Id
- OG002
- spread
- 36.80
- value
- 148.45
- title
- Day 3
- categories
- measurements
- group Id
- OG000
- spread
- 18.88
- value
- 71.19
- group Id
- OG001
- spread
- 47.01
- value
- 167.01
- group Id
- OG002
- spread
- 40.29
- value
- 165.16
- title
- Day 4
- categories
- measurements
- group Id
- OG000
- spread
- 23.89
- value
- 79.39
- group Id
- OG001
- spread
- 25.30
- value
- 167.27
- group Id
- OG002
- spread
- 47.26
- value
- 174.58
- title
- Day 5
- categories
- measurements
- group Id
- OG000
- spread
- 26.72
- value
- 74.09
- group Id
- OG001
- spread
- 49.42
- value
- 239.51
- group Id
- OG002
- spread
- 54.10
- value
- 230.42
- title
- Day 6
- categories
- measurements
- group Id
- OG000
- spread
- 29.39
- value
- 109.27
- group Id
- OG001
- spread
- 65.65
- value
- 283.15
- group Id
- OG002
- spread
- 104.52
- value
- 267.89
- title
- Day 7
- categories
- measurements
- group Id
- OG000
- spread
- 30.92
- value
- 110.61
- group Id
- OG001
- spread
- 93.63
- value
- 368.31
- group Id
- OG002
- spread
- 78.58
- value
- 140.58
- title
- Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 11.53
- value
- -35.73
- group Id
- OG001
- spread
- 11.15
- value
- -8.60
- group Id
- OG002
- spread
- 20.38
- value
- -41.33
- 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
- Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)
- type
- SECONDARY
- unit Of Measure
- % change
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Preserved source evidence · Not medical advice
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