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NCT03951220 · OUTCOME

Secondary Outcome 2: Detect Longitudinal Changes in Bone Microarchitecture With Therapy (% 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
MEAN
Unit
Ratio (follow-up divided by baseline)
Interval / dispersion
Standard Deviation
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 whether longitudinal change in bone turnover markers differed by chemotherapy responders vs non-responders. * The % change in bone biomarker measurements was expressed as a ratio of follow-up / baseline of paired measurements * Participants were classified by International Myeloma Working Group (IMWG) Response Group classification, as responder (partial response, very good partial response or complete response) or non-responder (stable, progressive or relapse).

Analysis population: Pooled cohort of participants from Groups 1 and 2 who had a IMWG response classification (responder vs non-responder) and paired serum bone turnover markers measured at baseline and follow-up.

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 P1NP30
% Change in CTX-130
% Change in ALP32
% Change in DKK130
% Change in Sclerostin31
% Change in RANKL:OPG29

Reported measurements

IMWG Responder

Analysis denominator · Participants

GroupSource count
% Change in P1NP15
% Change in CTX-115
% Change in ALP17
% Change in DKK115
% Change in Sclerostin16
% Change in RANKL:OPG15
Values in Ratio (follow-up divided by baseline) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
% Change in P1NP0.940.75Not reportedNot reportedNot reported
% Change in CTX-10.890.73Not reportedNot reportedNot reported
% Change in ALP0.850.22Not reportedNot reportedNot reported
% Change in DKK10.630.40Not reportedNot reportedNot reported
% Change in Sclerostin1.220.64Not reportedNot reportedNot reported
% Change in RANKL:OPG1.090.81Not reportedNot reportedNot reported
IMWG Non-Responder

Analysis denominator · Participants

GroupSource count
% Change in P1NP15
% Change in CTX-115
% Change in ALP15
% Change in DKK115
% Change in Sclerostin15
% Change in RANKL:OPG14
Values in Ratio (follow-up divided by baseline) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
% Change in P1NP0.950.21Not reportedNot reportedNot reported
% Change in CTX-11.180.51Not reportedNot reportedNot reported
% Change in ALP0.980.23Not reportedNot reportedNot reported
% Change in DKK11.150.59Not reportedNot reportedNot reported
% Change in Sclerostin1.180.41Not reportedNot reportedNot reported
% Change in RANKL:OPG1.511.04Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG003
    non Inferiority Type
    OTHER
    p Value
    0.007
    statistical Method
    Mann-Whitney test
Complete source fields
analyses
  1. group Ids
    1. OG003
    non Inferiority Type
    OTHER
    p Value
    0.007
    statistical Method
    Mann-Whitney test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.75
        value
        0.94
      2. group Id
        OG001
        spread
        0.73
        value
        0.89
      3. group Id
        OG002
        spread
        0.22
        value
        0.85
      4. group Id
        OG003
        spread
        0.40
        value
        0.63
      5. group Id
        OG004
        spread
        0.64
        value
        1.22
      6. group Id
        OG005
        spread
        0.81
        value
        1.09
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        15
      3. group Id
        OG002
        value
        17
      4. group Id
        OG003
        value
        15
      5. group Id
        OG004
        value
        16
      6. group Id
        OG005
        value
        15
      units
      Participants
    title
    IMWG Responder
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.21
        value
        0.95
      2. group Id
        OG001
        spread
        0.51
        value
        1.18
      3. group Id
        OG002
        spread
        0.23
        value
        0.98
      4. group Id
        OG003
        spread
        0.59
        value
        1.15
      5. group Id
        OG004
        spread
        0.41
        value
        1.18
      6. group Id
        OG005
        spread
        1.04
        value
        1.51
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        15
      3. group Id
        OG002
        value
        15
      4. group Id
        OG003
        value
        15
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        14
      units
      Participants
    title
    IMWG Non-Responder
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      30
    3. group Id
      OG002
      value
      32
    4. group Id
      OG003
      value
      30
    5. group Id
      OG004
      value
      31
    6. group Id
      OG005
      value
      29
    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 whether longitudinal change in bone turnover markers differed by chemotherapy responders vs non-responders. * The % change in bone biomarker measurements was expressed as a ratio of follow-up / baseline of paired measurements * Participants were classified by International Myeloma Working Group (IMWG) Response Group classification, as responder (partial response, very good partial response or complete response) or non-responder (stable, progressive or relapse).
dispersion Type
Standard Deviation
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
MEAN
population Description
Pooled cohort of participants from Groups 1 and 2 who had a IMWG response classification (responder vs non-responder) and paired serum bone turnover markers measured at baseline and follow-up.
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 (% Change in Bone Turnover Markers)
type
SECONDARY
unit Of Measure
Ratio (follow-up divided by baseline)

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Preserved source evidence · Not medical advice