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NCT03951220 · OUTCOME

Secondary Outcome 2: Detect Longitudinal Changes in Bone Microarchitecture With Therapy [Correlations Between % Change in Bone Turnover Markers With % Change in Bone Mineral Density (BMD) or Apparent Diffusion Coefficient (ADC)]

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 section examined the correlation (using Spearman's Rank Correlation Coefficient) between longitudinal changes (expressed as a ratio of follow-up / baseline of paired measurements) in bone turnover markers and: 1. Longitudinal changes in DXA Bone Mineral Density (BMD) at lumbar spine (L1-4) and femoral neck; 2. Longitudinal changes in novel MR Apparent Diffusion Coefficient (ADC) measurements.

Analysis population: Participants from Groups 1 and 2 were analysed who had a paired bone turnover marker measurements available. Where the number analysed for an outcome measure is lower than the overall number of participants analysed, this is due to failure of measurement of either DXA BMD or novel MR ADC, or because ADC measurement was not indicated due to lack of a lytic bone lesion identified on MR.

Groups in this outcome

% Change in P1NP

% Change in measurements of P1NP (Procollagen type 1 N-terminal Propeptide).

% 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 P1NP41
% Change in CTX-140
% Change in ALP42
% Change in DKK143
% Change in Sclerostin42
% Change in RANKL:OPG38

Reported measurements

% Change in Novel MR ADC

Analysis denominator · Participants

GroupSource count
% Change in P1NP7
% Change in CTX-16
% Change in ALP7
% Change in DKK17
% Change in Sclerostin7
% Change in RANKL:OPG7
Values in Spearman's rank correlation coefficient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
% Change in P1NP-0.39Not reportedNANAInsufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient
% Change in CTX-10.31Not reportedNANAInsufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient
% Change in ALP-0.50Not reportedNANAInsufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient
% Change in DKK1-0.32Not reportedNANAInsufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient
% Change in Sclerostin-0.32Not reportedNANAInsufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient
% Change in RANKL:OPG-0.14Not reportedNANAInsufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient
% Change in DXA BMD (L1-4)

Analysis denominator · Participants

GroupSource count
% Change in P1NP41
% Change in CTX-140
% Change in ALP42
% 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 P1NP-0.12Not reported-0.420.21Not reported
% Change in CTX-1-0.10Not reported-0.410.23Not reported
% Change in ALP0.02Not reported-0.290.33Not reported
% Change in DKK10.02Not reported-0.290.33Not reported
% Change in Sclerostin0.24Not reported-0.080.51Not reported
% Change in RANKL:OPG-0.17Not reported-0.480.16Not reported
% Change in DXA BMD (Femoral Neck)

Analysis denominator · Participants

GroupSource count
% Change in P1NP39
% Change in CTX-138
% Change in ALP40
% Change in DKK141
% Change in Sclerostin40
% Change in RANKL:OPG36
Values in Spearman's rank correlation coefficient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
% Change in P1NP-0.20Not reported-0.500.13Not reported
% Change in CTX-1-0.10Not reported-0.410.24Not reported
% Change in ALP-0.17Not reported-0.470.16Not reported
% Change in DKK1-0.09Not reported-0.390.24Not reported
% Change in Sclerostin0.00Not reported-0.320.32Not reported
% Change in RANKL:OPG-0.45Not reported-0.68-0.13Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        -0.39
      2. comment
        Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        0.31
      3. comment
        Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        -0.50
      4. comment
        Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        -0.32
      5. comment
        Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        -0.32
      6. comment
        Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        -0.14
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        7
      units
      Participants
    title
    % Change in Novel MR ADC
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.42
        upper Limit
        0.21
        value
        -0.12
      2. group Id
        OG001
        lower Limit
        -0.41
        upper Limit
        0.23
        value
        -0.10
      3. group Id
        OG002
        lower Limit
        -0.29
        upper Limit
        0.33
        value
        0.02
      4. group Id
        OG003
        lower Limit
        -0.29
        upper Limit
        0.33
        value
        0.02
      5. group Id
        OG004
        lower Limit
        -0.08
        upper Limit
        0.51
        value
        0.24
      6. group Id
        OG005
        lower Limit
        -0.48
        upper Limit
        0.16
        value
        -0.17
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      2. group Id
        OG001
        value
        40
      3. group Id
        OG002
        value
        42
      4. group Id
        OG003
        value
        43
      5. group Id
        OG004
        value
        42
      6. group Id
        OG005
        value
        38
      units
      Participants
    title
    % Change in DXA BMD (L1-4)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.50
        upper Limit
        0.13
        value
        -0.20
      2. group Id
        OG001
        lower Limit
        -0.41
        upper Limit
        0.24
        value
        -0.10
      3. group Id
        OG002
        lower Limit
        -0.47
        upper Limit
        0.16
        value
        -0.17
      4. group Id
        OG003
        lower Limit
        -0.39
        upper Limit
        0.24
        value
        -0.09
      5. group Id
        OG004
        lower Limit
        -0.32
        upper Limit
        0.32
        value
        0.00
      6. group Id
        OG005
        lower Limit
        -0.68
        upper Limit
        -0.13
        value
        -0.45
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        38
      3. group Id
        OG002
        value
        40
      4. group Id
        OG003
        value
        41
      5. group Id
        OG004
        value
        40
      6. group Id
        OG005
        value
        36
      units
      Participants
    title
    % Change in DXA BMD (Femoral Neck)
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      40
    3. group Id
      OG002
      value
      42
    4. group Id
      OG003
      value
      43
    5. group Id
      OG004
      value
      42
    6. group Id
      OG005
      value
      38
    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 section examined the correlation (using Spearman's Rank Correlation Coefficient) between longitudinal changes (expressed as a ratio of follow-up / baseline of paired measurements) in bone turnover markers and: 1. Longitudinal changes in DXA Bone Mineral Density (BMD) at lumbar spine (L1-4) and femoral neck; 2. Longitudinal changes in novel MR Apparent Diffusion Coefficient (ADC) measurements.
dispersion Type
95% Confidence Interval
groups
  1. description
    % Change in measurements of P1NP (Procollagen type 1 N-terminal Propeptide).
    id
    OG000
    title
    % Change in P1NP
  2. description
    % Change in measurements of CTX-1 (Type I Collagen Cross-Linked C-Telopeptide).
    id
    OG001
    title
    % Change in CTX-1
  3. description
    % Change in measurements of ALP (Alkaline Phosphatase).
    id
    OG002
    title
    % Change in ALP
  4. description
    % Change in measurements of DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1).
    id
    OG003
    title
    % Change in DKK1
  5. description
    % Change in measurements of sclerostin.
    id
    OG004
    title
    % Change in Sclerostin
  6. description
    % Change in measurements of the ratio between RANKL and OPG (osteoprotegerin).
    id
    OG005
    title
    % Change in RANKL:OPG
param Type
NUMBER
population Description
Participants from Groups 1 and 2 were analysed who had a paired bone turnover marker measurements available. Where the number analysed for an outcome measure is lower than the overall number of participants analysed, this is due to failure of measurement of either DXA BMD or novel MR ADC, or because ADC measurement was not indicated due to lack of a lytic bone lesion identified on MR.
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 With % Change in Bone Mineral Density (BMD) or Apparent Diffusion Coefficient (ADC)]
type
SECONDARY
unit Of Measure
Spearman's rank correlation coefficient

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

Preserved source evidence · Not medical advice