TriangleNCT02604433 · OUTCOME
Mean Change From Baseline In Total Hip And Lumbar Spine Bone Mineral Density (BMD) At Week 48
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- gm/cm^2
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline: Day 1; Treatment: Week 48
What was measured
For BMD, the lumbar spine and total hip were measured at baseline and 48 weeks by dual energy x-ray absorptiometry (DXA). Baseline was defined as the last value on or before the first dose of study drug is administered; if multiple values are present for the same date, the average of these values was used. If during the 48 week double-blinded treatment period, a participant has only one assessment, it is counted as 'Week 48' visit; if a participant has multiple assessments, the last one is used as 'Week 48' visit. The analysis was done on the population that had at least 2 measurements.
Analysis population: All randomized participants with available measurements at the specified timepoints
Groups in this outcome
Luspatercept + BSC
Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period. BSC = Best Supportive Care
Placebo + BSC
Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days. BSC = Best Supportive Care
| Group | Source count |
|---|---|
| Luspatercept + BSC | 190 |
| Placebo + BSC | 97 |
Reported measurements
Total Hip
| Group | Source count |
|---|---|
| Luspatercept + BSC | 190 |
| Placebo + BSC | 97 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept + BSC | 0.01 | 0.050 | Not reported | Not reported | Not reported |
| Placebo + BSC | 0.01 | 0.057 | Not reported | Not reported | Not reported |
Lumbar Spine
| Group | Source count |
|---|---|
| Luspatercept + BSC | 189 |
| Placebo + BSC | 97 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept + BSC | -0.00 | 0.063 | Not reported | Not reported | Not reported |
| Placebo + BSC | 0.00 | 0.078 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.01
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.01
- estimate Comment
- luspatercept - placebo
- group Description
- Total Hip Bone Mineral Density: Change from baseline at Week 48 LS = least squares
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9201
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- param Type
- LS Mean of Difference
- param Value
- 0.00
- statistical Comment
- Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.
- statistical Method
- ANCOVA
- ci Lower Limit
- -0.02
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.01
- estimate Comment
- luspatercept - placebo
- group Description
- Lumbar Spine Bone Mineral Density: Change from baseline at Week 48 LS = least squares
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.4620
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- param Type
- LS Mean of Difference
- param Value
- -0.01
- statistical Comment
- Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Lower Limit
- -0.01
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.01
- estimate Comment
- luspatercept - placebo
- group Description
- Total Hip Bone Mineral Density: Change from baseline at Week 48 LS = least squares
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9201
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- param Type
- LS Mean of Difference
- param Value
- 0.00
- statistical Comment
- Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.
- statistical Method
- ANCOVA
- ci Lower Limit
- -0.02
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.01
- estimate Comment
- luspatercept - placebo
- group Description
- Lumbar Spine Bone Mineral Density: Change from baseline at Week 48 LS = least squares
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.4620
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- param Type
- LS Mean of Difference
- param Value
- -0.01
- statistical Comment
- Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.050
- value
- 0.01
- group Id
- OG001
- spread
- 0.057
- value
- 0.01
- denoms
- counts
- group Id
- OG000
- value
- 190
- group Id
- OG001
- value
- 97
- units
- Participants
- title
- Total Hip
- categories
- measurements
- group Id
- OG000
- spread
- 0.063
- value
- -0.00
- group Id
- OG001
- spread
- 0.078
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 189
- group Id
- OG001
- value
- 97
- units
- Participants
- title
- Lumbar Spine
- denoms
- counts
- group Id
- OG000
- value
- 190
- group Id
- OG001
- value
- 97
- units
- Participants
- description
- For BMD, the lumbar spine and total hip were measured at baseline and 48 weeks by dual energy x-ray absorptiometry (DXA). Baseline was defined as the last value on or before the first dose of study drug is administered; if multiple values are present for the same date, the average of these values was used. If during the 48 week double-blinded treatment period, a participant has only one assessment, it is counted as 'Week 48' visit; if a participant has multiple assessments, the last one is used as 'Week 48' visit. The analysis was done on the population that had at least 2 measurements.
- dispersion Type
- Standard Deviation
- groups
- description
- Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period. BSC = Best Supportive Care
- id
- OG000
- title
- Luspatercept + BSC
- description
- Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days. BSC = Best Supportive Care
- id
- OG001
- title
- Placebo + BSC
- param Type
- MEAN
- population Description
- All randomized participants with available measurements at the specified timepoints
- reporting Status
- POSTED
- time Frame
- Baseline: Day 1; Treatment: Week 48
- title
- Mean Change From Baseline In Total Hip And Lumbar Spine Bone Mineral Density (BMD) At Week 48
- type
- SECONDARY
- unit Of Measure
- gm/cm^2
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Preserved source evidence · Not medical advice