Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00396279 · OUTCOME

Serum Denosumab Trough Concentrations

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
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Blood samples were collected on Days 1 (baseline), 8, 15 and Weeks 5 (Day 29), 9, 13, 25, and 49.

What was measured

Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA).

Analysis population: The pharmacokinetics analysis set included participants who received at least 1 dose of denosumab and for whom at least 1 serum denosumab trough concentration was available. 'n' indicates the number of participants with available data at each time point.

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
Denosumab37

Reported measurements

Day 1 (n=32)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DenosumabNANANot reportedNot reportedBelow the lower limit of quantification
Day 8 (n=32)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Denosumab1900024100Not reportedNot reportedNot reported
Day 15 (n=28)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Denosumab3160027300Not reportedNot reportedNot reported
Day 29 (n=33)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Denosumab3640020600Not reportedNot reportedNot reported
Week 9 (n=32)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Denosumab2750017300Not reportedNot reportedNot reported
Week 13 (n=25)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Denosumab2330012400Not reportedNot reportedNot reported
Week 25 (n=23)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Denosumab199009700Not reportedNot reportedNot reported
Week 49 (n=9)
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Denosumab214008900Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Below the lower limit of quantification
        group Id
        OG000
        spread
        NA
        value
        NA
    title
    Day 1 (n=32)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        24100
        value
        19000
    title
    Day 8 (n=32)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        27300
        value
        31600
    title
    Day 15 (n=28)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        20600
        value
        36400
    title
    Day 29 (n=33)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        17300
        value
        27500
    title
    Week 9 (n=32)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        12400
        value
        23300
    title
    Week 13 (n=25)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        9700
        value
        19900
    title
    Week 25 (n=23)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        8900
        value
        21400
    title
    Week 49 (n=9)
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    units
    Participants
description
Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA).
dispersion Type
Standard Deviation
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
MEAN
population Description
The pharmacokinetics analysis set included participants who received at least 1 dose of denosumab and for whom at least 1 serum denosumab trough concentration was available. 'n' indicates the number of participants with available data at each time point.
reporting Status
POSTED
time Frame
Blood samples were collected on Days 1 (baseline), 8, 15 and Weeks 5 (Day 29), 9, 13, 25, and 49.
title
Serum Denosumab Trough Concentrations
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice