TriangleNCT01286077 · OUTCOME
Change From Baseline in Spine T-score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- T score
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline up to end of study (approximately 4 years 7 months)
What was measured
T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of '50' and a standard deviation of '10'. T score lower than its mean indicate low bone mineral density.
Analysis population: FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure. Missing data was imputed by last observation carried forward (LOCF) method.
Groups in this outcome
Bortezomib
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
Non-treated Control
no treatment, observation only
| Group | Source count |
|---|---|
| Bortezomib | 13 |
| Non-treated Control | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib | 1.2028 | 0.2004 | Not reported | Not reported | Not reported |
| Non-treated Control | 1.1811 | 0.1689 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.2004
- value
- 1.2028
- group Id
- OG001
- spread
- 0.1689
- value
- 1.1811
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 21
- units
- Participants
- description
- T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of '50' and a standard deviation of '10'. T score lower than its mean indicate low bone mineral density.
- dispersion Type
- Standard Deviation
- groups
- description
- bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
- id
- OG000
- title
- Bortezomib
- description
- no treatment, observation only
- id
- OG001
- title
- Non-treated Control
- param Type
- MEAN
- population Description
- FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure. Missing data was imputed by last observation carried forward (LOCF) method.
- reporting Status
- POSTED
- time Frame
- Baseline up to end of study (approximately 4 years 7 months)
- title
- Change From Baseline in Spine T-score
- type
- SECONDARY
- unit Of Measure
- T score
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice