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NCT03027557 · OUTCOME

Mean P-calcium During Treatment.

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
mmol/l
Interval / dispersion
Standard Error
Time frame
Monthly up to one year.

What was measured

Blood samples were acquired once every 4 weeks for safety-purposes.

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.15
Denosumab Monotherapy16
Placebo15

Analysis denominator · p-calcium measurements

GroupSource count
Combined Treatment.210
Denosumab Monotherapy240
Placebo224

Reported measurements

Source class 1
Values in mmol/l · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Combined Treatment.1.280.007Not reportedNot reportedNot reported
Denosumab Monotherapy1.380.006Not reportedNot reportedNot reported
Placebo1.400.004Not 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
    = 0.0001
    statistical Method
    ANOVA
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    = 0.0001
    statistical Method
    ANOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.007
        value
        1.28
      2. group Id
        OG001
        spread
        0.006
        value
        1.38
      3. group Id
        OG002
        spread
        0.004
        value
        1.40
denom Units Selected
p-calcium measurements
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      15
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      210
    2. group Id
      OG001
      value
      240
    3. group Id
      OG002
      value
      224
    units
    p-calcium measurements
description
Blood samples were acquired once every 4 weeks for safety-purposes.
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
reporting Status
POSTED
time Frame
Monthly up to one year.
title
Mean P-calcium During Treatment.
type
SECONDARY
type Units Analyzed
p-calcium measurements
unit Of Measure
mmol/l

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

Preserved source evidence · Not medical advice