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NCT00171925 · OUTCOME

The Number of Participants With the Development of Skeletal Complications

Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I · Source last updated 2012-04-11

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
48 months

What was measured

* Pathologic fracture: bone fractures that occur spontaneously or from trivial trauma. New vertebral compression fracture defined as a decrease in vertebral height of 25% from baseline * Spinal cord compression: the impingement of tumor on the spinal cord confirmed by radiography * Bone Radiotherapy: Bone irradiation to palliate painful lesions, treat or prevent pathologic fractures or spinal cord compression * Surgery on bone: surgical procedures performed to set, stabilize or prevent pathologic fractures or areas of spinal cord compression * Hypercalcemia: Corrected serum calcium ≥ 12.0 mg/dl

Analysis population: Intent to treat population

Groups in this outcome

Zoledronic Acid (ZOL446)

Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.

Control

No Treatment with study medication.

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

Analysis denominator · Participants

GroupSource count
Zoledronic Acid (ZOL446)71
Control69

Reported measurements

Skeletal events overall
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zoledronic Acid (ZOL446)0Not reportedNot reportedNot reportedNot reported
Control4Not reportedNot reportedNot reportedNot reported
Pathological fracture
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zoledronic Acid (ZOL446)0Not reportedNot reportedNot reportedNot reported
Control1Not reportedNot reportedNot reportedNot reported
Initiation of radiotherapy or surgery on bone
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zoledronic Acid (ZOL446)0Not reportedNot reportedNot reportedNot reported
Control1Not reportedNot reportedNot reportedNot reported
Spinal cord compression
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zoledronic Acid (ZOL446)0Not reportedNot reportedNot reportedNot reported
Control2Not reportedNot reportedNot reportedNot reported
Hypercalcemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zoledronic Acid (ZOL446)0Not reportedNot reportedNot reportedNot reported
Control0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
    title
    Skeletal events overall
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Pathological fracture
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Initiation of radiotherapy or surgery on bone
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Spinal cord compression
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Hypercalcemia
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    2. group Id
      OG001
      value
      69
    units
    Participants
description
* Pathologic fracture: bone fractures that occur spontaneously or from trivial trauma. New vertebral compression fracture defined as a decrease in vertebral height of 25% from baseline * Spinal cord compression: the impingement of tumor on the spinal cord confirmed by radiography * Bone Radiotherapy: Bone irradiation to palliate painful lesions, treat or prevent pathologic fractures or spinal cord compression * Surgery on bone: surgical procedures performed to set, stabilize or prevent pathologic fractures or areas of spinal cord compression * Hypercalcemia: Corrected serum calcium ≥ 12.0 mg/dl
groups
  1. description
    Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
    id
    OG000
    title
    Zoledronic Acid (ZOL446)
  2. description
    No Treatment with study medication.
    id
    OG001
    title
    Control
param Type
NUMBER
population Description
Intent to treat population
reporting Status
POSTED
time Frame
48 months
title
The Number of Participants With the Development of Skeletal Complications
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice