NCT00622505 · OUTCOME
Change From Baseline in Urinary N-telopeptide of Type 1 Collagen (uNTx)
Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants · Source last updated 2021-05-26
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- nmol/mmol creatinine
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 and 100/End of Study (EOS)
What was measured
uNTx is a biomarker used to measure the rate of bone turnover found in urine.
Analysis population: Safety analysis set included all enrolled participants who received at least 1 dose of zoledronic acid. 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Zoledronic Acid Every 12 Weeks | 79 |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 42 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Zoledronic Acid Every 12 Weeks | 79 |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 42 |
|---|
Values in nmol/mmol creatinine · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zoledronic Acid Every 12 Weeks | 19.8 | 8.82 | Not reported | Not reported | Not reported |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 24.1 | 15.63 | Not reported | Not reported | Not reported |
|---|
Change from Baseline to Week 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Zoledronic Acid Every 12 Weeks | 74 |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 41 |
|---|
Values in nmol/mmol creatinine · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zoledronic Acid Every 12 Weeks | 0.2 | 11.50 | Not reported | Not reported | Not reported |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 4.3 | 19.47 | Not reported | Not reported | Not reported |
|---|
Change from Baseline to Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Zoledronic Acid Every 12 Weeks | 73 |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 40 |
|---|
Values in nmol/mmol creatinine · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zoledronic Acid Every 12 Weeks | -1.4 | 8.72 | Not reported | Not reported | Not reported |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | -0.5 | 15.66 | Not reported | Not reported | Not reported |
|---|
Change from Baseline to Week 36
Analysis denominator · Participants
| Group | Source count |
|---|
| Zoledronic Acid Every 12 Weeks | 65 |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 40 |
|---|
Values in nmol/mmol creatinine · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zoledronic Acid Every 12 Weeks | -2.0 | 9.77 | Not reported | Not reported | Not reported |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | -0.9 | 13.92 | Not reported | Not reported | Not reported |
|---|
Change from Baseline to Week 48
Analysis denominator · Participants
| Group | Source count |
|---|
| Zoledronic Acid Every 12 Weeks | 63 |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 37 |
|---|
Values in nmol/mmol creatinine · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zoledronic Acid Every 12 Weeks | -2.3 | 9.24 | Not reported | Not reported | Not reported |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 1.7 | 18.39 | Not reported | Not reported | Not reported |
|---|
Change from Baseline to Week 60
Analysis denominator · Participants
| Group | Source count |
|---|
| Zoledronic Acid Every 12 Weeks | 59 |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 32 |
|---|
Values in nmol/mmol creatinine · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zoledronic Acid Every 12 Weeks | -2.5 | 12.30 | Not reported | Not reported | Not reported |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | -0.8 | 17.54 | Not reported | Not reported | Not reported |
|---|
Change from Baseline to Week 72
Analysis denominator · Participants
| Group | Source count |
|---|
| Zoledronic Acid Every 12 Weeks | 57 |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 29 |
|---|
Values in nmol/mmol creatinine · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zoledronic Acid Every 12 Weeks | -3.5 | 10.99 | Not reported | Not reported | Not reported |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | -6.7 | 15.50 | Not reported | Not reported | Not reported |
|---|
Change from Baseline to Week 84
Analysis denominator · Participants
| Group | Source count |
|---|
| Zoledronic Acid Every 12 Weeks | 55 |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 23 |
|---|
Values in nmol/mmol creatinine · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zoledronic Acid Every 12 Weeks | -3.0 | 10.73 | Not reported | Not reported | Not reported |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | -7.6 | 18.51 | Not reported | Not reported | Not reported |
|---|
Change from Baseline to Week 100
Analysis denominator · Participants
| Group | Source count |
|---|
| Zoledronic Acid Every 12 Weeks | 59 |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | 25 |
|---|
Values in nmol/mmol creatinine · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zoledronic Acid Every 12 Weeks | -5.2 | 9.25 | Not reported | Not reported | Not reported |
|---|
| Zoledronic Acid Every 4 Weeks or 12 Weeks | -7.4 | 17.68 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 8.82
- value
- 19.8
- group Id
- OG001
- spread
- 15.63
- value
- 24.1
- denoms
- counts
- group Id
- OG000
- value
- 79
- group Id
- OG001
- value
- 42
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 11.50
- value
- 0.2
- group Id
- OG001
- spread
- 19.47
- value
- 4.3
- denoms
- counts
- group Id
- OG000
- value
- 74
- group Id
- OG001
- value
- 41
- units
- Participants
- title
- Change from Baseline to Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 8.72
- value
- -1.4
- group Id
- OG001
- spread
- 15.66
- value
- -0.5
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 40
- units
- Participants
- title
- Change from Baseline to Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 9.77
- value
- -2.0
- group Id
- OG001
- spread
- 13.92
- value
- -0.9
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 40
- units
- Participants
- title
- Change from Baseline to Week 36
- categories
- measurements
- group Id
- OG000
- spread
- 9.24
- value
- -2.3
- group Id
- OG001
- spread
- 18.39
- value
- 1.7
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 37
- units
- Participants
- title
- Change from Baseline to Week 48
- categories
- measurements
- group Id
- OG000
- spread
- 12.30
- value
- -2.5
- group Id
- OG001
- spread
- 17.54
- value
- -0.8
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 32
- units
- Participants
- title
- Change from Baseline to Week 60
- categories
- measurements
- group Id
- OG000
- spread
- 10.99
- value
- -3.5
- group Id
- OG001
- spread
- 15.50
- value
- -6.7
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 29
- units
- Participants
- title
- Change from Baseline to Week 72
- categories
- measurements
- group Id
- OG000
- spread
- 10.73
- value
- -3.0
- group Id
- OG001
- spread
- 18.51
- value
- -7.6
- denoms
- counts
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 23
- units
- Participants
- title
- Change from Baseline to Week 84
- categories
- measurements
- group Id
- OG000
- spread
- 9.25
- value
- -5.2
- group Id
- OG001
- spread
- 17.68
- value
- -7.4
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 25
- units
- Participants
- title
- Change from Baseline to Week 100
- denoms
- counts
- group Id
- OG000
- value
- 79
- group Id
- OG001
- value
- 42
- units
- Participants
- description
- uNTx is a biomarker used to measure the rate of bone turnover found in urine.
- 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
- Safety analysis set included all enrolled participants who received at least 1 dose of zoledronic acid. Number analyzed signifies the number of participants with data available for analysis at given time point.
- reporting Status
- POSTED
- time Frame
- Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 and 100/End of Study (EOS)
- title
- Change From Baseline in Urinary N-telopeptide of Type 1 Collagen (uNTx)
- type
- SECONDARY
- unit Of Measure
- nmol/mmol creatinine
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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