NCT03027557 · OUTCOME
Median Agatstons Score Final
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- score on a scale
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Baseline, one year
What was measured
Simultaneously with QCT-measurements coronary calcification was be assessed. Agatston score is a score based on the extent of coronary artery calcification calculated on the amount of plaque observed in a CT scan. A score of zero indicates absence of coronary calcium, 1-10: minimal calcification, 11-100 mild calcification, 101-400 moderate calcification, \>400 severe calcification. Thus the score increases with increasing level of calcification in the coronary vessels.
Analysis population: Some participant from the combined and placebo groups could not be included in the analysis because they had coronary stents.
Groups in this outcome
Combined Treatment.
15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.
Denosumab Monotherapy
16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.
Placebo
15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.
| Group | Source count |
|---|---|
| Combined Treatment. | 12 |
| Denosumab Monotherapy | 16 |
| Placebo | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combined Treatment. | 5.0 | Not reported | 0.0 | 78.1 | Not reported |
| Denosumab Monotherapy | 24.3 | Not reported | 0.7 | 602.1 | Not reported |
| Placebo | 117.8 | Not reported | 6.8 | 182.6 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- = 0.38
- statistical Method
- Kruskal-Wallis
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- = 0.38
- statistical Method
- Kruskal-Wallis
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 78.1
- value
- 5.0
- group Id
- OG001
- lower Limit
- 0.7
- upper Limit
- 602.1
- value
- 24.3
- group Id
- OG002
- lower Limit
- 6.8
- upper Limit
- 182.6
- value
- 117.8
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 13
- units
- Participants
- description
- Simultaneously with QCT-measurements coronary calcification was be assessed. Agatston score is a score based on the extent of coronary artery calcification calculated on the amount of plaque observed in a CT scan. A score of zero indicates absence of coronary calcium, 1-10: minimal calcification, 11-100 mild calcification, 101-400 moderate calcification, \>400 severe calcification. Thus the score increases with increasing level of calcification in the coronary vessels.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- 15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.
- id
- OG000
- title
- Combined Treatment.
- description
- 16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.
- id
- OG001
- title
- Denosumab Monotherapy
- description
- 15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.
- id
- OG002
- title
- Placebo
- param Type
- MEDIAN
- population Description
- Some participant from the combined and placebo groups could not be included in the analysis because they had coronary stents.
- reporting Status
- POSTED
- time Frame
- Baseline, one year
- title
- Median Agatstons Score Final
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle