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NCT03960437 · OUTCOME

Change in Bone Mineral Density (BMD) of the Spine by DXA

The Effect of Etelcalcetide on CKD-MBD · Source last updated 2023-09-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Z-score
Interval / dispersion
Standard Error
Time frame
Baseline and 9 months

What was measured

To test if 9-months of treatment with etelcalcetide improves spine BMD, a change in age and sex adjusted Z-Score will be calculated from baseline to 9 months. A Z-Score of zero represent the population mean and higher Z-Scores indicate a better outcome.

Analysis population: Only includes participants who completed the study.

Groups in this outcome

Study Participant

Every study participant will receive etelcalcetide prescribed by their treating physician for the duration of the study. Etelcalcetide: Administered intravenously at the end of each dialysis session. Dosing ranges from 5 mg to 15 mg set by the patient's physician.

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

Analysis denominator · Participants

GroupSource count
Study Participant13

Reported measurements

Source class 1
Values in Z-score · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Study Participant0.270.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.1
        value
        0.27
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
To test if 9-months of treatment with etelcalcetide improves spine BMD, a change in age and sex adjusted Z-Score will be calculated from baseline to 9 months. A Z-Score of zero represent the population mean and higher Z-Scores indicate a better outcome.
dispersion Type
Standard Error
groups
  1. description
    Every study participant will receive etelcalcetide prescribed by their treating physician for the duration of the study. Etelcalcetide: Administered intravenously at the end of each dialysis session. Dosing ranges from 5 mg to 15 mg set by the patient's physician.
    id
    OG000
    title
    Study Participant
param Type
MEAN
population Description
Only includes participants who completed the study.
reporting Status
POSTED
time Frame
Baseline and 9 months
title
Change in Bone Mineral Density (BMD) of the Spine by DXA
type
SECONDARY
unit Of Measure
Z-score

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

Preserved source evidence · Not medical advice