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NCT03027557 · OUTCOME

Change in Lumbar Spine Bone Mineral Density

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
MEAN
Unit
g/cm^2
Interval / dispersion
Standard Error
Time frame
Baseline,one year

What was measured

Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.

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

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 g/cm^2 · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Combined Treatment.0.0300.009Not reportedNot reportedNot reported
Denosumab Monotherapy0.0420.009Not reportedNot reportedNot reported
Placebo-0.0160.007Not reportedNot reportedNot 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
    < 0.00001
    statistical Method
    ANOVA
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.00001
    statistical Method
    ANOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.009
        value
        0.030
      2. group Id
        OG001
        spread
        0.009
        value
        0.042
      3. group Id
        OG002
        spread
        0.007
        value
        -0.016
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      15
    units
    Participants
description
Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.
dispersion Type
Standard Error
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
MEAN
population Description
One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan.
reporting Status
POSTED
time Frame
Baseline,one year
title
Change in Lumbar Spine Bone Mineral Density
type
PRIMARY
unit Of Measure
g/cm^2

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

Preserved source evidence · Not medical advice