TriangleNCT00622505 · OUTCOME
Percentage of Participants With ≥1 SRE at the End of 1 Year on Study
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 1 year
What was measured
SRE was defined as pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or hypercalcemia of malignancy (HCM). SRE was assessed by centrally read radiographic bone surveys.
Analysis population: ITT analysis set included all participants who were enrolled in this study.
Groups in this outcome
Zoledronic Acid Every 12 Weeks
Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \<50 nmol/mmol creatinine).
Zoledronic Acid Every 4 Weeks or 12 Weeks
Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \<50 nmol/mmol creatinine, respectively).
| Group | Source count |
|---|---|
| Zoledronic Acid Every 12 Weeks | 79 |
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zoledronic Acid Every 12 Weeks | 0 | Not reported | NA | NA | Upper and lower limits of 95% CI were not estimable due to the smaller number of participants with the event. |
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 0.17 | Not reported | 0.05 | 0.28 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper and lower limits of 95% CI were not estimable due to the smaller number of participants with the event.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- group Id
- OG001
- lower Limit
- 0.05
- upper Limit
- 0.28
- value
- 0.17
- denoms
- counts
- group Id
- OG000
- value
- 79
- group Id
- OG001
- value
- 42
- units
- Participants
- description
- SRE was defined as pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or hypercalcemia of malignancy (HCM). SRE was assessed by centrally read radiographic bone surveys.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \<50 nmol/mmol creatinine).
- id
- OG000
- title
- Zoledronic Acid Every 12 Weeks
- description
- Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \<50 nmol/mmol creatinine, respectively).
- id
- OG001
- title
- Zoledronic Acid Every 4 Weeks or 12 Weeks
- param Type
- NUMBER
- population Description
- ITT analysis set included all participants who were enrolled in this study.
- reporting Status
- POSTED
- time Frame
- 1 year
- title
- Percentage of Participants With ≥1 SRE at the End of 1 Year on Study
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice