TriangleNCT00556374 · OUTCOME
Time to First Clinical Fracture
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until the primary analysis cut-off date of 26 March 2014; maximum time on main study at the cut-off was 87 months
What was measured
The time to first on-study clinical fracture was defined as the number of days from randomization to the date of the x-ray confirming the clinical fracture. A clinical fracture is any clinically evident fracture with associated symptoms and confirmed by x-ray. Participants who died or withdrew without experiencing a clinical fracture were censored at the date of last contact or study termination whichever was earlier.
Analysis population: Full Analysis Set: all randomized participants
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 | 1709 |
| Denosumab | 1711 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | NA | Not reported | NA | NA | Not reached due to the low number of events |
| Denosumab | NA | Not reported | NA | NA | Not reached due to the low number of events |
Source statistical analyses
- ci Lower Limit
- 0.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.65
- estimate Comment
- From the Cox proportional hazard model with treatment as the independent variable and stratified by randomization strata. A hazard ratio \< 1.0 indicates a lower average event rate and a longer fracture-free time for denosumab relative to placebo.
- group Description
- The efficacy clinical hypothesis is that denosumab, when administered subcutaneously at a dose of 60 mg every 6 months, will be considered efficacious in patients with non-metastatic breast cancer receiving AIT if the rate of first clinical fracture in denosumab-treated patients is lower than that in placebo-treated patients. It is anticipated that denosumab will reduce the rate by 30% compared with placebo (ie, the true hazard ratio of denosumab compared with placebo is 0.70).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.504
- statistical Comment
- Stratification factors are hospital type, prior use of aromatase inhibitor, and baseline lumbar spine BMD.
- statistical Method
- Cox Proportional Hazards Model
Complete source fields
- analyses
- ci Lower Limit
- 0.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.65
- estimate Comment
- From the Cox proportional hazard model with treatment as the independent variable and stratified by randomization strata. A hazard ratio \< 1.0 indicates a lower average event rate and a longer fracture-free time for denosumab relative to placebo.
- group Description
- The efficacy clinical hypothesis is that denosumab, when administered subcutaneously at a dose of 60 mg every 6 months, will be considered efficacious in patients with non-metastatic breast cancer receiving AIT if the rate of first clinical fracture in denosumab-treated patients is lower than that in placebo-treated patients. It is anticipated that denosumab will reduce the rate by 30% compared with placebo (ie, the true hazard ratio of denosumab compared with placebo is 0.70).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.504
- statistical Comment
- Stratification factors are hospital type, prior use of aromatase inhibitor, and baseline lumbar spine BMD.
- statistical Method
- Cox Proportional Hazards Model
- classes
- categories
- measurements
- comment
- Not reached due to the low number of events
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Not reached due to the low number of events
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 1709
- group Id
- OG001
- value
- 1711
- units
- Participants
- description
- The time to first on-study clinical fracture was defined as the number of days from randomization to the date of the x-ray confirming the clinical fracture. A clinical fracture is any clinically evident fracture with associated symptoms and confirmed by x-ray. Participants who died or withdrew without experiencing a clinical fracture were censored at the date of last contact or study termination whichever was earlier.
- 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
- MEDIAN
- population Description
- Full Analysis Set: all randomized participants
- reporting Status
- POSTED
- time Frame
- From randomization until the primary analysis cut-off date of 26 March 2014; maximum time on main study at the cut-off was 87 months
- title
- Time to First Clinical Fracture
- type
- PRIMARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice