TriangleNCT00104104 · OUTCOME
Zoledronic Acid Concentrations
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- 24 months
What was measured
Samples for drug concentration analysis were drawn at 10 and 15 minutes into the infusion for participants in the 15-minute infusion group and at 25 and 30 minutes into the infusion for patients in the 30-minute infusion group. The mean and median zoledronic acid concentrations were greater in the 15-minute group than in the 30-minute group at both sampling timepoints.
Analysis population: The pharmacokinetic (PK) population was analyzed for zoledronic acid concentration. Participants were considered to be in the PK population if they had evaluable PK data.
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 | 70 |
| 30 - Minute Infusion | 63 |
Reported measurements
First Collection (10 minutes, 25 minutes)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 15 - Minute Infusion | 231.1 | 185.4 | Not reported | Not reported | Not reported |
| 30 - Minute Infusion | 186.3 | 54.4 | Not reported | Not reported | Not reported |
Second Collection (15 minutes, 30 minutes)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 15 - Minute Infusion | 248.8 | 92.0 | Not reported | Not reported | Not reported |
| 30 - Minute Infusion | 172.0 | 48.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 185.4
- value
- 231.1
- group Id
- OG001
- spread
- 54.4
- value
- 186.3
- title
- First Collection (10 minutes, 25 minutes)
- categories
- measurements
- group Id
- OG000
- spread
- 92.0
- value
- 248.8
- group Id
- OG001
- spread
- 48.3
- value
- 172.0
- title
- Second Collection (15 minutes, 30 minutes)
- denoms
- counts
- group Id
- OG000
- value
- 70
- group Id
- OG001
- value
- 63
- units
- Participants
- description
- Samples for drug concentration analysis were drawn at 10 and 15 minutes into the infusion for participants in the 15-minute infusion group and at 25 and 30 minutes into the infusion for patients in the 30-minute infusion group. The mean and median zoledronic acid concentrations were greater in the 15-minute group than in the 30-minute group at both sampling timepoints.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- The pharmacokinetic (PK) population was analyzed for zoledronic acid concentration. Participants were considered to be in the PK population if they had evaluable PK data.
- reporting Status
- POSTED
- time Frame
- 24 months
- title
- Zoledronic Acid Concentrations
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice