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NCT00396279 · OUTCOME

Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)

Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone · Source last updated 2022-11-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
percent change
Interval / dispersion
Inter-Quartile Range
Time frame
Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81

What was measured

Serum C-terminus peptide (of type 1 collagen; CTX1) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in CTX was measured over time.

Analysis population: Efficacy Analysis Set with available data at each time point (n).

Groups in this outcome

Denosumab

Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.

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

Analysis denominator · Participants

GroupSource count
Denosumab35

Reported measurements

Week 5 (n=33)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-78.9Not reported-85.2-71.2Not reported
Week 9 (n=33)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-79.8Not reported-87.9-66.1Not reported
Week 13 (n=31)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-80.4Not reported-85.7-71.3Not reported
Week 17 (n=28)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-82.6Not reported-85.2-70.4Not reported
Week 21 (n=26)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-82.0Not reported-87.0-66.4Not reported
Week 25 (n=24)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-79.5Not reported-86.5-69.2Not reported
Week 29 (n=21)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-82.8Not reported-85.2-60.3Not reported
Week 33 (n=16)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-74.8Not reported-83.2-59.0Not reported
Week 37 (n=14)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-82.4Not reported-87.0-69.6Not reported
Week 41 (n=10)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-86.1Not reported-89.6-58.5Not reported
Week 45 (n=8)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-79.6Not reported-86.4-70.0Not reported
Week 49 (n=7)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-82.0Not reported-90.0-76.7Not reported
Week 53 (N=8)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-87.3Not reported-89.8-84.2Not reported
Week 57 (n=6)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-86.2Not reported-87.7-85.2Not reported
Week 61 (n=4)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-84.9Not reported-88.3-83.0Not reported
Week 65 (n=3)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-83.5Not reported-87.0-77.5Not reported
Week 69 (n=4)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-84.2Not reported-86.9-80.0Not reported
Week 73 (n=2)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-81.9Not reported-85.2-78.5Not reported
Week 77 (n=2)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-84.2Not reported-87.5-80.9Not reported
Week 81 (n=2)
Values in percent change · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Denosumab-84.9Not reported-89.6-80.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -85.2
        upper Limit
        -71.2
        value
        -78.9
    title
    Week 5 (n=33)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -87.9
        upper Limit
        -66.1
        value
        -79.8
    title
    Week 9 (n=33)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -85.7
        upper Limit
        -71.3
        value
        -80.4
    title
    Week 13 (n=31)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -85.2
        upper Limit
        -70.4
        value
        -82.6
    title
    Week 17 (n=28)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -87.0
        upper Limit
        -66.4
        value
        -82.0
    title
    Week 21 (n=26)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -86.5
        upper Limit
        -69.2
        value
        -79.5
    title
    Week 25 (n=24)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -85.2
        upper Limit
        -60.3
        value
        -82.8
    title
    Week 29 (n=21)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -83.2
        upper Limit
        -59.0
        value
        -74.8
    title
    Week 33 (n=16)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -87.0
        upper Limit
        -69.6
        value
        -82.4
    title
    Week 37 (n=14)
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -89.6
        upper Limit
        -58.5
        value
        -86.1
    title
    Week 41 (n=10)
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -86.4
        upper Limit
        -70.0
        value
        -79.6
    title
    Week 45 (n=8)
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -90.0
        upper Limit
        -76.7
        value
        -82.0
    title
    Week 49 (n=7)
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
Serum C-terminus peptide (of type 1 collagen; CTX1) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in CTX was measured over time.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
    id
    OG000
    title
    Denosumab
param Type
MEDIAN
population Description
Efficacy Analysis Set with available data at each time point (n).
reporting Status
POSTED
time Frame
Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81
title
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
type
SECONDARY
unit Of Measure
percent change

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice