TriangleNCT00104104 · OUTCOME
The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline and 12 Months
What was measured
The primary renal safety endpoint was the number of participants with a clinically relevant increase in serum creatinine at 12 months. Serum creatinine was determined prior to each zoledronic acid infusion for all Participants and was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.
Analysis population: Safety Population: enrolled patients who received at least one dose of study medication, exluding site 74.
Groups in this outcome
15 - Minute Infusion
Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
30 - Minute Infusion
Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
| Group | Source count |
|---|---|
| 15 - Minute Infusion | 85 |
| 30 - Minute Infusion | 84 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 15 - Minute Infusion | 17 | Not reported | 0.43 | 2.65 | Not reported |
| 30 - Minute Infusion | 13 | Not reported | 0.43 | 2.65 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.43
- upper Limit
- 2.65
- value
- 17
- group Id
- OG001
- lower Limit
- 0.43
- upper Limit
- 2.65
- value
- 13
- denoms
- counts
- group Id
- OG000
- value
- 85
- group Id
- OG001
- value
- 84
- units
- Participants
- description
- The primary renal safety endpoint was the number of participants with a clinically relevant increase in serum creatinine at 12 months. Serum creatinine was determined prior to each zoledronic acid infusion for all Participants and was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.
- groups
- description
- Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
- id
- OG000
- title
- 15 - Minute Infusion
- description
- Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
- id
- OG001
- title
- 30 - Minute Infusion
- param Type
- NUMBER
- population Description
- Safety Population: enrolled patients who received at least one dose of study medication, exluding site 74.
- reporting Status
- POSTED
- time Frame
- Baseline and 12 Months
- title
- The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice