NCT00580788 · OUTCOME
Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)
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 | 32.86 | 23.41 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 87.75 | 18.79 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 54.21 | 10.64 | Not reported | Not reported | Not reported |
|---|
Day 3
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 26.73 | 23.19 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 91.53 | 28.94 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 88.51 | 19.99 | Not reported | Not reported | Not reported |
|---|
Day 4
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 28.32 | 20.26 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 90.86 | 32.25 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 89.57 | 20.22 | Not reported | Not reported | Not reported |
|---|
Day 5
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 41.29 | 20.06 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 82.36 | 20.62 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 116.58 | 13.85 | Not reported | Not reported | Not reported |
|---|
Day 6
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 11.41 | 12.63 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 123.08 | 28.62 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 150.82 | 48.26 | Not reported | Not reported | Not reported |
|---|
Day 7
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 35.04 | 21.44 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 161.55 | 41.54 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 176.42 | 50.08 | Not reported | Not reported | Not reported |
|---|
Day 8
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | 65.77 | 30.43 | Not reported | Not reported | Not reported |
|---|
| Group 2 | 214.90 | 59.26 | Not reported | Not reported | Not reported |
|---|
| Group 3 | 108.69 | 34.29 | Not reported | Not reported | Not reported |
|---|
follow-up
Values in % change · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Group 1 | -14.95 | 2.97 | Not reported | Not reported | Not reported |
|---|
| Group 2 | -3.33 | 6.68 | Not reported | Not reported | Not reported |
|---|
| Group 3 | -9.02 | 7.19 | 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
- <.008
- p Value Comment
- The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on 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 the 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
- <.008
- p Value Comment
- The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on 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 the 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
- 23.41
- value
- 32.86
- group Id
- OG001
- spread
- 18.79
- value
- 87.75
- group Id
- OG002
- spread
- 10.64
- value
- 54.21
- title
- Day 2
- categories
- measurements
- group Id
- OG000
- spread
- 23.19
- value
- 26.73
- group Id
- OG001
- spread
- 28.94
- value
- 91.53
- group Id
- OG002
- spread
- 19.99
- value
- 88.51
- title
- Day 3
- categories
- measurements
- group Id
- OG000
- spread
- 20.26
- value
- 28.32
- group Id
- OG001
- spread
- 32.25
- value
- 90.86
- group Id
- OG002
- spread
- 20.22
- value
- 89.57
- title
- Day 4
- categories
- measurements
- group Id
- OG000
- spread
- 20.06
- value
- 41.29
- group Id
- OG001
- spread
- 20.62
- value
- 82.36
- group Id
- OG002
- spread
- 13.85
- value
- 116.58
- title
- Day 5
- categories
- measurements
- group Id
- OG000
- spread
- 12.63
- value
- 11.41
- group Id
- OG001
- spread
- 28.62
- value
- 123.08
- group Id
- OG002
- spread
- 48.26
- value
- 150.82
- title
- Day 6
- categories
- measurements
- group Id
- OG000
- spread
- 21.44
- value
- 35.04
- group Id
- OG001
- spread
- 41.54
- value
- 161.55
- group Id
- OG002
- spread
- 50.08
- value
- 176.42
- title
- Day 7
- categories
- measurements
- group Id
- OG000
- spread
- 30.43
- value
- 65.77
- group Id
- OG001
- spread
- 59.26
- value
- 214.90
- group Id
- OG002
- spread
- 34.29
- value
- 108.69
- title
- Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 2.97
- value
- -14.95
- group Id
- OG001
- spread
- 6.68
- value
- -3.33
- group Id
- OG002
- spread
- 7.19
- value
- -9.02
- 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 Amino-terminal Telopeptide of Collagen -1 (sNTX)
- type
- SECONDARY
- unit Of Measure
- % change
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Preserved source evidence · Not medical advice
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