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NCT03951220 · OUTCOME

Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum Ratio of RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand) and OPG (Osteoprotegerin)

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
RANKL (pg/L) to OPG (pg/L) ratio
Interval / dispersion
Standard Deviation
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. This particular section analysed the inter-group difference in baseline ratio between RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand) and OPG (Osteoprotegerin) \[calculated as RANKL (pg/L) divided by OPG (pg/L)\] bone turnover marker levels, in patients from Groups 1a (new myeloma), 1b (relapsed myeloma), 1c (smouldering myeloma) and 2 (MGUS).

Analysis population: All participants recruited at baseline from Groups 1 and 2 who had successful measurement of both baseline serum RANKL and baseline serum OPG.

Groups in this outcome

Group 1a: New Myeloma

Cohort of patients recruited as new myeloma at baseline

Group 1b: Relapsed Myeloma

Cohort of patients recruited as relapsed myeloma at baseline

Group 1c: Smouldering Myeloma

Cohort of patients recruited as smouldering myeloma at baseline

Group 2: MGUS

Cohort of patients recruited as MGUS at baseline

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

Analysis denominator · Participants

GroupSource count
Group 1a: New Myeloma14
Group 1b: Relapsed Myeloma12
Group 1c: Smouldering Myeloma15
Group 2: MGUS12

Reported measurements

Source class 1
Values in RANKL (pg/L) to OPG (pg/L) ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1a: New Myeloma0.01700.0205Not reportedNot reportedNot reported
Group 1b: Relapsed Myeloma0.01760.0221Not reportedNot reportedNot reported
Group 1c: Smouldering Myeloma0.03970.1524Not reportedNot reportedNot reported
Group 2: MGUS0.03860.1494Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0205
        value
        0.0170
      2. group Id
        OG001
        spread
        0.0221
        value
        0.0176
      3. group Id
        OG002
        spread
        0.1524
        value
        0.0397
      4. group Id
        OG003
        spread
        0.1494
        value
        0.0386
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      15
    4. group Id
      OG003
      value
      12
    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. This particular section analysed the inter-group difference in baseline ratio between RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand) and OPG (Osteoprotegerin) \[calculated as RANKL (pg/L) divided by OPG (pg/L)\] bone turnover marker levels, in patients from Groups 1a (new myeloma), 1b (relapsed myeloma), 1c (smouldering myeloma) and 2 (MGUS).
dispersion Type
Standard Deviation
groups
  1. description
    Cohort of patients recruited as new myeloma at baseline
    id
    OG000
    title
    Group 1a: New Myeloma
  2. description
    Cohort of patients recruited as relapsed myeloma at baseline
    id
    OG001
    title
    Group 1b: Relapsed Myeloma
  3. description
    Cohort of patients recruited as smouldering myeloma at baseline
    id
    OG002
    title
    Group 1c: Smouldering Myeloma
  4. description
    Cohort of patients recruited as MGUS at baseline
    id
    OG003
    title
    Group 2: MGUS
param Type
MEAN
population Description
All participants recruited at baseline from Groups 1 and 2 who had successful measurement of both baseline serum RANKL and baseline serum OPG.
reporting Status
POSTED
time Frame
At baseline
title
Primary Outcome 2: Quantifying Bone Loss - Inter-Group Differences in Baseline Serum Ratio of RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand) and OPG (Osteoprotegerin)
type
PRIMARY
unit Of Measure
RANKL (pg/L) to OPG (pg/L) ratio

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

Preserved source evidence · Not medical advice