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NCT03951220 · OUTCOME

Primary Outcome 2: Quantifying Bone Loss [Correlations Between Bone Turnover Markers, DXA (Dual-energy X-ray Absorptiometry) and ADC (Apparent Diffusion Coefficient)]

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
At baseline

What was measured

Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone. In this particular section, in a pooled cohort of participants from Groups 1 and 2, Spearman's rank correlation coefficients were calculated between all baseline bone turnover biomarkers and: 1. Baseline novel MR Apparent Diffusion Coefficient (ADC) measurements; 2. Baseline DXA (Dual-energy X-ray Absorptiometry) BMD (Bone Mineral Density) at lumbar spine (L1-4); 2\) Baseline DXA (Dual-energy X-ray Absorptiometry) BMD (Bone Mineral Density) at femoral neck.

Analysis population: Pooled population of participants from Groups 1 and 2. Where the numbers analysed are lower than the overall number of participants analysed, this reflects either failure of paired measurements for bone turnover marker and DXA and ADC, or that ADC measurements were not indicated because baseline novel MR scan did not show a lytic lesion.

Groups in this outcome

Baseline P1NP

Baseline measurements of P1NP (Procollagen type 1 N-terminal Propeptide).

Baseline CTX-1

Baseline measurements of CTX-1 (Type I Collagen Cross-Linked C-Telopeptide).

Baseline ALP

Baseline measurements of ALP (Alkaline Phosphatase).

Baseline DKK1

Baseline measurements of DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1).

Baseline Sclerostin

Baseline measurements of sclerostin.

Baseline RANKL:OPG

Baseline 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
Baseline P1NP55
Baseline CTX-155
Baseline ALP55
Baseline DKK155
Baseline Sclerostin55
Baseline RANKL:OPG55

Reported measurements

DXA BMD for L1-4 (Spearman's Rank Correlation Coefficient)

Analysis denominator · Participants

GroupSource count
Baseline P1NP53
Baseline CTX-150
Baseline ALP54
Baseline DKK155
Baseline Sclerostin55
Baseline RANKL:OPG53
Values in Spearman's rank correlation coefficient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Baseline P1NP0.02Not reported-0.260.29Not reported
Baseline CTX-10.00Not reported-0.290.29Not reported
Baseline ALP0.16Not reported-0.120.41Not reported
Baseline DKK10.25Not reported-0.030.49Not reported
Baseline Sclerostin0.54Not reported0.310.71Not reported
Baseline RANKL:OPG-0.02Not reported-0.300.26Not reported
DXA BMD for Femoral Neck (Spearman's Rank Correlation Coefficient)

Analysis denominator · Participants

GroupSource count
Baseline P1NP51
Baseline CTX-148
Baseline ALP52
Baseline DKK153
Baseline Sclerostin53
Baseline RANKL:OPG51
Values in Spearman's rank correlation coefficient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Baseline P1NP0.09Not reported-0.200.37Not reported
Baseline CTX-10.14Not reported-0.160.41Not reported
Baseline ALP0.11Not reported-0.170.38Not reported
Baseline DKK10.19Not reported-0.100.44Not reported
Baseline Sclerostin0.40Not reported0.130.61Not reported
Baseline RANKL:OPG0.10Not reported-0.190.37Not reported
Novel MR ADC Measurement (Spearman's Rank Correlation Coefficient)

Analysis denominator · Participants

GroupSource count
Baseline P1NP12
Baseline CTX-110
Baseline ALP12
Baseline DKK112
Baseline Sclerostin12
Baseline RANKL:OPG12
Values in Spearman's rank correlation coefficient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Baseline P1NP0.09Not reported-0.520.64Not reported
Baseline CTX-1-0.06Not reportedNANAInsufficient number of paired baseline CTX-1 and novel MR ADC values to enable statistical detection of Spearman's Rank correlation coefficient
Baseline ALP-0.27Not reported-0.740.37Not reported
Baseline DKK1-0.01Not reported-0.590.58Not reported
Baseline Sclerostin-0.42Not reported-0.810.21Not reported
Baseline RANKL:OPG0.09Not reported-0.300.26Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.26
        upper Limit
        0.29
        value
        0.02
      2. group Id
        OG001
        lower Limit
        -0.29
        upper Limit
        0.29
        value
        0.00
      3. group Id
        OG002
        lower Limit
        -0.12
        upper Limit
        0.41
        value
        0.16
      4. group Id
        OG003
        lower Limit
        -0.03
        upper Limit
        0.49
        value
        0.25
      5. group Id
        OG004
        lower Limit
        0.31
        upper Limit
        0.71
        value
        0.54
      6. group Id
        OG005
        lower Limit
        -0.30
        upper Limit
        0.26
        value
        -0.02
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      2. group Id
        OG001
        value
        50
      3. group Id
        OG002
        value
        54
      4. group Id
        OG003
        value
        55
      5. group Id
        OG004
        value
        55
      6. group Id
        OG005
        value
        53
      units
      Participants
    title
    DXA BMD for L1-4 (Spearman's Rank Correlation Coefficient)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.20
        upper Limit
        0.37
        value
        0.09
      2. group Id
        OG001
        lower Limit
        -0.16
        upper Limit
        0.41
        value
        0.14
      3. group Id
        OG002
        lower Limit
        -0.17
        upper Limit
        0.38
        value
        0.11
      4. group Id
        OG003
        lower Limit
        -0.10
        upper Limit
        0.44
        value
        0.19
      5. group Id
        OG004
        lower Limit
        0.13
        upper Limit
        0.61
        value
        0.40
      6. group Id
        OG005
        lower Limit
        -0.19
        upper Limit
        0.37
        value
        0.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        48
      3. group Id
        OG002
        value
        52
      4. group Id
        OG003
        value
        53
      5. group Id
        OG004
        value
        53
      6. group Id
        OG005
        value
        51
      units
      Participants
    title
    DXA BMD for Femoral Neck (Spearman's Rank Correlation Coefficient)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.52
        upper Limit
        0.64
        value
        0.09
      2. comment
        Insufficient number of paired baseline CTX-1 and novel MR ADC values to enable statistical detection of Spearman's Rank correlation coefficient
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        -0.06
      3. group Id
        OG002
        lower Limit
        -0.74
        upper Limit
        0.37
        value
        -0.27
      4. group Id
        OG003
        lower Limit
        -0.59
        upper Limit
        0.58
        value
        -0.01
      5. group Id
        OG004
        lower Limit
        -0.81
        upper Limit
        0.21
        value
        -0.42
      6. group Id
        OG005
        lower Limit
        -0.30
        upper Limit
        0.26
        value
        0.09
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        12
      5. group Id
        OG004
        value
        12
      6. group Id
        OG005
        value
        12
      units
      Participants
    title
    Novel MR ADC Measurement (Spearman's Rank Correlation Coefficient)
denoms
  1. counts
    1. group Id
      OG000
      value
      55
    2. group Id
      OG001
      value
      55
    3. group Id
      OG002
      value
      55
    4. group Id
      OG003
      value
      55
    5. group Id
      OG004
      value
      55
    6. group Id
      OG005
      value
      55
    units
    Participants
description
Primary Outcome 2: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone turnover markers can improve quantification of bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy Of Uncertain Significance (MGUS) at baseline assessment, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone turnover markers alone. In this particular section, in a pooled cohort of participants from Groups 1 and 2, Spearman's rank correlation coefficients were calculated between all baseline bone turnover biomarkers and: 1. Baseline novel MR Apparent Diffusion Coefficient (ADC) measurements; 2. Baseline DXA (Dual-energy X-ray Absorptiometry) BMD (Bone Mineral Density) at lumbar spine (L1-4); 2\) Baseline DXA (Dual-energy X-ray Absorptiometry) BMD (Bone Mineral Density) at femoral neck.
dispersion Type
95% Confidence Interval
groups
  1. description
    Baseline measurements of P1NP (Procollagen type 1 N-terminal Propeptide).
    id
    OG000
    title
    Baseline P1NP
  2. description
    Baseline measurements of CTX-1 (Type I Collagen Cross-Linked C-Telopeptide).
    id
    OG001
    title
    Baseline CTX-1
  3. description
    Baseline measurements of ALP (Alkaline Phosphatase).
    id
    OG002
    title
    Baseline ALP
  4. description
    Baseline measurements of DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1).
    id
    OG003
    title
    Baseline DKK1
  5. description
    Baseline measurements of sclerostin.
    id
    OG004
    title
    Baseline Sclerostin
  6. description
    Baseline measurements of the ratio between RANKL and OPG (osteoprotegerin).
    id
    OG005
    title
    Baseline RANKL:OPG
param Type
NUMBER
population Description
Pooled population of participants from Groups 1 and 2. Where the numbers analysed are lower than the overall number of participants analysed, this reflects either failure of paired measurements for bone turnover marker and DXA and ADC, or that ADC measurements were not indicated because baseline novel MR scan did not show a lytic lesion.
reporting Status
POSTED
time Frame
At baseline
title
Primary Outcome 2: Quantifying Bone Loss [Correlations Between Bone Turnover Markers, DXA (Dual-energy X-ray Absorptiometry) and ADC (Apparent Diffusion Coefficient)]
type
PRIMARY
unit Of Measure
Spearman's rank correlation coefficient

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Preserved source evidence · Not medical advice