TriangleNCT00622505 · OUTCOME
Skeletal Related Event (SRE) Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- number of SRE/total follow-up time
- Interval / dispersion
- Standard Deviation
- Time frame
- Years 1 and 2
What was measured
The SRE rate for each participant was calculated as the number of SREs/total follow-up time. SRE included pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM.
Analysis population: ITT analysis set includes all participants who were enrolled in this study. Number analyzed signifies the number of participants with data available for analysis at given time point.
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
Year 1
| Group | Source count |
|---|---|
| Zoledronic Acid Every 12 Weeks | 79 |
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 42 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zoledronic Acid Every 12 Weeks | 0.00 | 0.00 | Not reported | Not reported | Not reported |
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 0.03 | 0.080 | Not reported | Not reported | Not reported |
Year 2
| Group | Source count |
|---|---|
| Zoledronic Acid Every 12 Weeks | 63 |
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 38 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zoledronic Acid Every 12 Weeks | 0.00 | 0.00 | Not reported | Not reported | Not reported |
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 0.02 | 0.049 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.00
- value
- 0.00
- group Id
- OG001
- spread
- 0.080
- value
- 0.03
- denoms
- counts
- group Id
- OG000
- value
- 79
- group Id
- OG001
- value
- 42
- units
- Participants
- title
- Year 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.00
- value
- 0.00
- group Id
- OG001
- spread
- 0.049
- value
- 0.02
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 38
- units
- Participants
- title
- Year 2
- denoms
- counts
- group Id
- OG000
- value
- 79
- group Id
- OG001
- value
- 42
- units
- Participants
- description
- The SRE rate for each participant was calculated as the number of SREs/total follow-up time. SRE included pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- ITT analysis set includes all participants who were enrolled in this study. Number analyzed signifies the number of participants with data available for analysis at given time point.
- reporting Status
- POSTED
- time Frame
- Years 1 and 2
- title
- Skeletal Related Event (SRE) Rate
- type
- SECONDARY
- unit Of Measure
- number of SRE/total follow-up time
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice