TriangleNCT00556374 · OUTCOME
Percent Change From Baseline in Total Lumbar Spine Bone Mineral Density (BMD) at Month 36 at Pre-selected Sites
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Percent Change in BMD
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline and Month 36
What was measured
Bone mineral density was assessed by dual x-ray absorptiometry.
Analysis population: BMD Analysis Set: all participants with evaluable lumbar spine BMD values at Baseline and Month 36
Groups in this outcome
Placebo
Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
Denosumab
Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
| Group | Source count |
|---|---|
| Placebo | 245 |
| Denosumab | 230 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -2.75 | Not reported | -3.44 | -2.07 | Not reported |
| Denosumab | 7.27 | Not reported | 6.56 | 7.98 | Not reported |
Source statistical analyses
- ci Lower Limit
- 9.04
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.01
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- p Value Comment
- The Hochberg procedure was used to control for multiplicity.
- param Type
- Difference from Placebo
- param Value
- 10.02
- statistical Comment
- Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Lower Limit
- 9.04
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.01
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- p Value Comment
- The Hochberg procedure was used to control for multiplicity.
- param Type
- Difference from Placebo
- param Value
- 10.02
- statistical Comment
- Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.44
- upper Limit
- -2.07
- value
- -2.75
- group Id
- OG001
- lower Limit
- 6.56
- upper Limit
- 7.98
- value
- 7.27
- denoms
- counts
- group Id
- OG000
- value
- 245
- group Id
- OG001
- value
- 230
- units
- Participants
- description
- Bone mineral density was assessed by dual x-ray absorptiometry.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
- id
- OG000
- title
- Placebo
- description
- Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
- id
- OG001
- title
- Denosumab
- param Type
- LEAST_SQUARES_MEAN
- population Description
- BMD Analysis Set: all participants with evaluable lumbar spine BMD values at Baseline and Month 36
- reporting Status
- POSTED
- time Frame
- Baseline and Month 36
- title
- Percent Change From Baseline in Total Lumbar Spine Bone Mineral Density (BMD) at Month 36 at Pre-selected Sites
- type
- SECONDARY
- unit Of Measure
- Percent Change in BMD
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice