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NCT03027557 · OUTCOME

Median Agatstons Score Final

Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet. · Source last updated 2021-05-25

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Combined Treatment.12
Denosumab Monotherapy16
Placebo13

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Combined Treatment.5.0Not reported0.078.1Not reported
Denosumab Monotherapy24.3Not reported0.7602.1Not reported
Placebo117.8Not reported6.8182.6Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    = 0.38
    statistical Method
    Kruskal-Wallis
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    = 0.38
    statistical Method
    Kruskal-Wallis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        78.1
        value
        5.0
      2. group Id
        OG001
        lower Limit
        0.7
        upper Limit
        602.1
        value
        24.3
      3. group Id
        OG002
        lower Limit
        6.8
        upper Limit
        182.6
        value
        117.8
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      16
    3. 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
  1. 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.
  2. description
    16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.
    id
    OG001
    title
    Denosumab Monotherapy
  3. 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