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Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma

NCT01345019 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1718

Last updated 2022-11-08

Study results available
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Summary

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.

Conditions

Interventions

DRUG

Denosumab

Administered by subcutaneous injection once every 4 weeks.

DRUG

Zoledronic acid

Administered by intravenous infusion over 15 minutes once every 4 weeks

DRUG

Placebo to Denosumab

Administered by subcutaneous injection once every 4 weeks.

DRUG

Placebo to zoledronic acid

Administered by intravenous infusion over 15 minutes once every 4 weeks

DRUG

Denosumab (for the open-label treatment phase)

Administered by subcutaneous injection once every 4 weeks.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-17
Primary Completion
2016-07-19
Completion
2019-03-29

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Ireland
  • Italy
  • Japan
  • Lithuania
  • Malaysia
  • New Zealand
  • Poland
  • Portugal
  • Russia
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01345019 on ClinicalTrials.gov