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NCT03027557 · OUTCOME

Change MDI-score

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
MDI-score
Interval / dispersion
Inter-Quartile Range
Time frame
Baseline, 6 mths, one year.

What was measured

Major Depression Inventory (MDI)-score, Baseline, 6 months, one year (week 52)., change between baseline and 1 year reported. The Major Depression Inventory (MDI) is a mood questionnaire developed by the World Health Organization. To calculate the total score, a sum of ten individual items (each with an individual score between 0-5, with 0 indicating absence of a symptom and 5 indicating constant presence of a given symptom) is used. A higher score signifies deeper depression with 50 being the maximum score.

Analysis population: One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final collection of MDI-questionnaires.

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.14
Denosumab Monotherapy16
Placebo15

Reported measurements

Source class 1
Values in MDI-score · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Combined Treatment.0.0Not reported-4.01.0Not reported
Denosumab Monotherapy-0.5Not reported-4.51.0Not reported
Placebo0.0Not reported-3.00.0Not 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
    = 0.83
    statistical Method
    Kruskal-Wallis
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    = 0.83
    statistical Method
    Kruskal-Wallis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -4.0
        upper Limit
        1.0
        value
        0.0
      2. group Id
        OG001
        lower Limit
        -4.5
        upper Limit
        1.0
        value
        -0.5
      3. group Id
        OG002
        lower Limit
        -3.0
        upper Limit
        0.0
        value
        0.0
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      15
    units
    Participants
description
Major Depression Inventory (MDI)-score, Baseline, 6 months, one year (week 52)., change between baseline and 1 year reported. The Major Depression Inventory (MDI) is a mood questionnaire developed by the World Health Organization. To calculate the total score, a sum of ten individual items (each with an individual score between 0-5, with 0 indicating absence of a symptom and 5 indicating constant presence of a given symptom) is used. A higher score signifies deeper depression with 50 being the maximum score.
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
One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final collection of MDI-questionnaires.
reporting Status
POSTED
time Frame
Baseline, 6 mths, one year.
title
Change MDI-score
type
SECONDARY
unit Of Measure
MDI-score

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice