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NCT03951220 · OUTCOME

Secondary Outcome 2: Detect Longitudinal Changes in Bone Microarchitecture With Therapy (Correlations Between % Change in Bone Turnover Markers)

The Development and Pilot Testing of a New MR Imaging Protocol to Quantify Myeloma Disease Burden and Bone Loss · Source last updated 2025-08-19

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

Measure
NUMBER
Unit
Spearman's rank correlation coefficient
Interval / dispersion
95% Confidence Interval
Time frame
Comparison between baseline and follow-up at 6month

What was measured

Secondary Objective 2: To assess whether the novel Magnetic Resonance (MR) protocol and exploratory bone biomarkers can improve detection of longitudinal changes in bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy of Undetermined Significance (MGUS) during therapy, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone biomarkers alone. This particular section examined the correlation between longitudinal changes in bone turnover markers between one another (calculated as a ratio of follow-up measurement divided by baseline measurement). Spearman's rank correlation was performed for the longitudinal % change between different biomarkers, to assess the relationship between longitudinal changes in these measures.

Analysis population: Pooled population of participants from Groups 1 and 2 who had paired measurements of follow-up and baseline bone turnover markers. For some rows, the total number of participants analysed are less than the overall number of participants analysed, due to assay failure of some bone biomarkers variably on individual samples.

Groups in this outcome

% Change in CTX-1

% Change in measurements of CTX-1 (Type I Collagen Cross-Linked C-Telopeptide).

% Change in ALP

% Change in measurements of ALP (Alkaline Phosphatase).

% Change in DKK1

% Change in measurements of DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1).

% Change in Sclerostin

% Change in measurements of sclerostin.

% Change in RANKL:OPG

% Change in measurements of the ratio between RANKL and OPG (osteoprotegerin).

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

Analysis denominator · Participants

GroupSource count
% Change in CTX-140
% Change in ALP43
% Change in DKK144
% Change in Sclerostin43
% Change in RANKL:OPG49

Reported measurements

% Change in P1NP

Analysis denominator · Participants

GroupSource count
% Change in CTX-140
% Change in ALP40
% Change in DKK142
% Change in Sclerostin41
% Change in RANKL:OPG37
Values in Spearman's rank correlation coefficient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
% Change in CTX-10.41Not reported0.100.64Not reported
% Change in ALP0.36Not reported0.050.61Not reported
% Change in DKK10.12Not reported-0.200.41Not reported
% Change in Sclerostin0.32Not reported0.000.58Not reported
% Change in RANKL:OPG0.41Not reported0.090.65Not reported
% Change in CTX-1

Analysis denominator · Participants

GroupSource count
% Change in CTX-10
% Change in ALP40
% Change in DKK140
% Change in Sclerostin39
% Change in RANKL:OPG35
Values in Spearman's rank correlation coefficient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
% Change in ALP0.08Not reported-0.240.39Not reported
% Change in DKK10.11Not reported-0.220.42Not reported
% Change in Sclerostin0.26Not reported-0.080.54Not reported
% Change in RANKL:OPG-0.03Not reported-0.370.32Not reported
% Change in ALP

Analysis denominator · Participants

GroupSource count
% Change in CTX-10
% Change in ALP0
% Change in DKK143
% Change in Sclerostin42
% Change in RANKL:OPG38
Values in Spearman's rank correlation coefficient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
% Change in DKK10.23Not reported-0.080.51Not reported
% Change in Sclerostin-0.01Not reported-0.320.31Not reported
% Change in RANKL:OPG-0.13Not reported-0.440.21Not reported
% Change in DKK1

Analysis denominator · Participants

GroupSource count
% Change in CTX-10
% Change in ALP0
% Change in DKK10
% Change in Sclerostin43
% Change in RANKL:OPG39
Values in Spearman's rank correlation coefficient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
% Change in Sclerostin0.13Not reported-0.180.43Not reported
% Change in RANKL:OPG0.14Not reported-0.200.44Not reported
% Change in Sclerostin

Analysis denominator · Participants

GroupSource count
% Change in CTX-10
% Change in ALP0
% Change in DKK10
% Change in Sclerostin0
% Change in RANKL:OPG39
Values in Spearman's rank correlation coefficient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
% Change in RANKL:OPG0.37Not reported0.060.62Not reported
% Change in RANKL:OPG

Analysis denominator · Participants

GroupSource count
% Change in CTX-10
% Change in ALP0
% Change in DKK10
% Change in Sclerostin0
% Change in RANKL:OPG0
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.10
        upper Limit
        0.64
        value
        0.41
      2. group Id
        OG001
        lower Limit
        0.05
        upper Limit
        0.61
        value
        0.36
      3. group Id
        OG002
        lower Limit
        -0.20
        upper Limit
        0.41
        value
        0.12
      4. group Id
        OG003
        lower Limit
        0.00
        upper Limit
        0.58
        value
        0.32
      5. group Id
        OG004
        lower Limit
        0.09
        upper Limit
        0.65
        value
        0.41
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        40
      3. group Id
        OG002
        value
        42
      4. group Id
        OG003
        value
        41
      5. group Id
        OG004
        value
        37
      units
      Participants
    title
    % Change in P1NP
  2. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        -0.24
        upper Limit
        0.39
        value
        0.08
      2. group Id
        OG002
        lower Limit
        -0.22
        upper Limit
        0.42
        value
        0.11
      3. group Id
        OG003
        lower Limit
        -0.08
        upper Limit
        0.54
        value
        0.26
      4. group Id
        OG004
        lower Limit
        -0.37
        upper Limit
        0.32
        value
        -0.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        40
      3. group Id
        OG002
        value
        40
      4. group Id
        OG003
        value
        39
      5. group Id
        OG004
        value
        35
      units
      Participants
    title
    % Change in CTX-1
  3. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        -0.08
        upper Limit
        0.51
        value
        0.23
      2. group Id
        OG003
        lower Limit
        -0.32
        upper Limit
        0.31
        value
        -0.01
      3. group Id
        OG004
        lower Limit
        -0.44
        upper Limit
        0.21
        value
        -0.13
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        43
      4. group Id
        OG003
        value
        42
      5. group Id
        OG004
        value
        38
      units
      Participants
    title
    % Change in ALP
  4. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        -0.18
        upper Limit
        0.43
        value
        0.13
      2. group Id
        OG004
        lower Limit
        -0.20
        upper Limit
        0.44
        value
        0.14
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        43
      5. group Id
        OG004
        value
        39
      units
      Participants
    title
    % Change in DKK1
  5. categories
    1. measurements
      1. group Id
        OG004
        lower Limit
        0.06
        upper Limit
        0.62
        value
        0.37
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        39
      units
      Participants
    title
    % Change in Sclerostin
  6. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    % Change in RANKL:OPG
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      43
    3. group Id
      OG002
      value
      44
    4. group Id
      OG003
      value
      43
    5. group Id
      OG004
      value
      49
    units
    Participants
description
Secondary Objective 2: To assess whether the novel Magnetic Resonance (MR) protocol and exploratory bone biomarkers can improve detection of longitudinal changes in bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy of Undetermined Significance (MGUS) during therapy, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone biomarkers alone. This particular section examined the correlation between longitudinal changes in bone turnover markers between one another (calculated as a ratio of follow-up measurement divided by baseline measurement). Spearman's rank correlation was performed for the longitudinal % change between different biomarkers, to assess the relationship between longitudinal changes in these measures.
dispersion Type
95% Confidence Interval
groups
  1. description
    % Change in measurements of CTX-1 (Type I Collagen Cross-Linked C-Telopeptide).
    id
    OG000
    title
    % Change in CTX-1
  2. description
    % Change in measurements of ALP (Alkaline Phosphatase).
    id
    OG001
    title
    % Change in ALP
  3. description
    % Change in measurements of DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1).
    id
    OG002
    title
    % Change in DKK1
  4. description
    % Change in measurements of sclerostin.
    id
    OG003
    title
    % Change in Sclerostin
  5. description
    % Change in measurements of the ratio between RANKL and OPG (osteoprotegerin).
    id
    OG004
    title
    % Change in RANKL:OPG
param Type
NUMBER
population Description
Pooled population of participants from Groups 1 and 2 who had paired measurements of follow-up and baseline bone turnover markers. For some rows, the total number of participants analysed are less than the overall number of participants analysed, due to assay failure of some bone biomarkers variably on individual samples.
reporting Status
POSTED
time Frame
Comparison between baseline and follow-up at 6month
title
Secondary Outcome 2: Detect Longitudinal Changes in Bone Microarchitecture With Therapy (Correlations Between % Change in Bone Turnover Markers)
type
SECONDARY
unit Of Measure
Spearman's rank correlation coefficient

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

Preserved source evidence · Not medical advice