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NCT03027557 · OUTCOME

Mean p-PTH 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
MEDIAN
Unit
pmol/l
Interval / dispersion
95% Confidence Interval
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-PTH measurements

GroupSource count
Combined Treatment.211
Denosumab Monotherapy240
Placebo225

Reported measurements

Source class 1
Values in pmol/l · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Combined Treatment.12.0Not reported11.112.9Not reported
Denosumab Monotherapy13.4Not reported12.714.2Not reported
Placebo9.9Not reported9.510.4Not 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
    Kruskal-Wallis
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    = 0.0001
    statistical Method
    Kruskal-Wallis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.1
        upper Limit
        12.9
        value
        12.0
      2. group Id
        OG001
        lower Limit
        12.7
        upper Limit
        14.2
        value
        13.4
      3. group Id
        OG002
        lower Limit
        9.5
        upper Limit
        10.4
        value
        9.9
denom Units Selected
p-PTH 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
      211
    2. group Id
      OG001
      value
      240
    3. group Id
      OG002
      value
      225
    units
    p-PTH measurements
description
Blood samples were acquired once every 4 weeks for safety-purposes.
dispersion Type
95% Confidence Interval
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
reporting Status
POSTED
time Frame
Monthly up to one year.
title
Mean p-PTH During Treatment.
type
SECONDARY
type Units Analyzed
p-PTH measurements
unit Of Measure
pmol/l

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

Preserved source evidence · Not medical advice