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NCT03951220 · OUTCOME

Primary Outcome 2: Quantifying Bone Loss (Inter-Biomarker Correlations)

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, Spearman's rank correlation coefficient was performed to assess correlations between all pairs of bone turnover markers, measured at baseline in a pooled cohort of participants from Groups 1 and 2: 1. P1NP (Procollagen Type 1 N-terminal Propeptide); 2. CTX-1 (Collagen Cross-Linked C-Telopeptide Type I); 3. ALP (Alkaline Phosphatase); 4. DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1); 5. Sclerostin; 6. Ratio of RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand) to OPG (Osteoprotegerin).

Analysis population: Pooled population of participants from Groups 1 and 2 who had bone biomarkers measured at baseline.

Groups in this outcome

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 CTX-150
Baseline ALP54
Baseline DKK154
Baseline Sclerostin54
Baseline RANKL:OPG51

Reported measurements

Baseline P1NP (Spearman's Rank Correlation Coefficient)

Analysis denominator · Participants

GroupSource count
Baseline CTX-150
Baseline ALP54
Baseline DKK154
Baseline Sclerostin54
Baseline RANKL:OPG51
Values in Spearman's rank correlation coefficient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Baseline CTX-10.70Not reported0.510.82Not reported
Baseline ALP0.37Not reported0.100.58Not reported
Baseline DKK10.12Not reported-0.160.39Not reported
Baseline Sclerostin0.22Not reported-0.070.47Not reported
Baseline RANKL:OPG-0.10Not reported-0.370.19Not reported
Baseline CTX-1 (Spearman's Rank Correlation Coefficient)

Analysis denominator · Participants

GroupSource count
Baseline CTX-10
Baseline ALP54
Baseline DKK154
Baseline Sclerostin54
Baseline RANKL:OPG51
Values in Spearman's rank correlation coefficient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Baseline ALP0.25Not reported-0.040.50Not reported
Baseline DKK10.00Not reported-0.280.29Not reported
Baseline Sclerostin0.32Not reported0.030.55Not reported
Baseline RANKL:OPG-0.21Not reported-0.470.09Not reported
Baseline ALP (Spearman's Rank Correlation Coefficient)

Analysis denominator · Participants

GroupSource count
Baseline CTX-10
Baseline ALP0
Baseline DKK154
Baseline Sclerostin54
Baseline RANKL:OPG51
Values in Spearman's rank correlation coefficient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Baseline DKK10.09Not reported-0.190.36Not reported
Baseline Sclerostin-0.04Not reported-0.310.24Not reported
Baseline RANKL:OPG-0.23Not reported-0.480.06Not reported
Baseline DKK1 (Spearman's Rank Correlation Coefficient)

Analysis denominator · Participants

GroupSource count
Baseline CTX-10
Baseline ALP0
Baseline DKK10
Baseline Sclerostin54
Baseline RANKL:OPG51
Values in Spearman's rank correlation coefficient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Baseline Sclerostin0.11Not reported-0.160.37Not reported
Baseline RANKL:OPG0.13Not reported-0.150.39Not reported
Baseline Sclerostin (Spearman's Rank Correlation Coefficient)

Analysis denominator · Participants

GroupSource count
Baseline CTX-10
Baseline ALP0
Baseline DKK10
Baseline Sclerostin0
Baseline RANKL:OPG51
Values in Spearman's rank correlation coefficient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Baseline RANKL:OPG-0.29Not reported-0.53-0.01Not reported
Baseline RANKL:OPG (Spearman's Rank Correlation Coefficient)

Analysis denominator · Participants

GroupSource count
Baseline CTX-10
Baseline ALP0
Baseline DKK10
Baseline Sclerostin0
Baseline RANKL:OPG0
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.51
        upper Limit
        0.82
        value
        0.70
      2. group Id
        OG001
        lower Limit
        0.10
        upper Limit
        0.58
        value
        0.37
      3. group Id
        OG002
        lower Limit
        -0.16
        upper Limit
        0.39
        value
        0.12
      4. group Id
        OG003
        lower Limit
        -0.07
        upper Limit
        0.47
        value
        0.22
      5. group Id
        OG004
        lower Limit
        -0.37
        upper Limit
        0.19
        value
        -0.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        54
      3. group Id
        OG002
        value
        54
      4. group Id
        OG003
        value
        54
      5. group Id
        OG004
        value
        51
      units
      Participants
    title
    Baseline P1NP (Spearman's Rank Correlation Coefficient)
  2. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        -0.04
        upper Limit
        0.50
        value
        0.25
      2. group Id
        OG002
        lower Limit
        -0.28
        upper Limit
        0.29
        value
        0.00
      3. group Id
        OG003
        lower Limit
        0.03
        upper Limit
        0.55
        value
        0.32
      4. group Id
        OG004
        lower Limit
        -0.47
        upper Limit
        0.09
        value
        -0.21
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        54
      3. group Id
        OG002
        value
        54
      4. group Id
        OG003
        value
        54
      5. group Id
        OG004
        value
        51
      units
      Participants
    title
    Baseline CTX-1 (Spearman's Rank Correlation Coefficient)
  3. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        -0.19
        upper Limit
        0.36
        value
        0.09
      2. group Id
        OG003
        lower Limit
        -0.31
        upper Limit
        0.24
        value
        -0.04
      3. group Id
        OG004
        lower Limit
        -0.48
        upper Limit
        0.06
        value
        -0.23
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        54
      4. group Id
        OG003
        value
        54
      5. group Id
        OG004
        value
        51
      units
      Participants
    title
    Baseline ALP (Spearman's Rank Correlation Coefficient)
  4. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        -0.16
        upper Limit
        0.37
        value
        0.11
      2. group Id
        OG004
        lower Limit
        -0.15
        upper Limit
        0.39
        value
        0.13
    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
        54
      5. group Id
        OG004
        value
        51
      units
      Participants
    title
    Baseline DKK1 (Spearman's Rank Correlation Coefficient)
  5. categories
    1. measurements
      1. group Id
        OG004
        lower Limit
        -0.53
        upper Limit
        -0.01
        value
        -0.29
    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
        51
      units
      Participants
    title
    Baseline Sclerostin (Spearman's Rank Correlation Coefficient)
  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
    Baseline RANKL:OPG (Spearman's Rank Correlation Coefficient)
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    2. group Id
      OG001
      value
      54
    3. group Id
      OG002
      value
      54
    4. group Id
      OG003
      value
      54
    5. group Id
      OG004
      value
      51
    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, Spearman's rank correlation coefficient was performed to assess correlations between all pairs of bone turnover markers, measured at baseline in a pooled cohort of participants from Groups 1 and 2: 1. P1NP (Procollagen Type 1 N-terminal Propeptide); 2. CTX-1 (Collagen Cross-Linked C-Telopeptide Type I); 3. ALP (Alkaline Phosphatase); 4. DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1); 5. Sclerostin; 6. Ratio of RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand) to OPG (Osteoprotegerin).
dispersion Type
95% Confidence Interval
groups
  1. description
    Baseline measurements of CTX-1 (Type I Collagen Cross-Linked C-Telopeptide).
    id
    OG000
    title
    Baseline CTX-1
  2. description
    Baseline measurements of ALP (Alkaline Phosphatase).
    id
    OG001
    title
    Baseline ALP
  3. description
    Baseline measurements of DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1).
    id
    OG002
    title
    Baseline DKK1
  4. description
    Baseline measurements of sclerostin.
    id
    OG003
    title
    Baseline Sclerostin
  5. description
    Baseline measurements of the ratio between RANKL and OPG (osteoprotegerin).
    id
    OG004
    title
    Baseline RANKL:OPG
param Type
NUMBER
population Description
Pooled population of participants from Groups 1 and 2 who had bone biomarkers measured at baseline.
reporting Status
POSTED
time Frame
At baseline
title
Primary Outcome 2: Quantifying Bone Loss (Inter-Biomarker Correlations)
type
PRIMARY
unit Of Measure
Spearman's rank correlation coefficient

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

Preserved source evidence · Not medical advice