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Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks

NCT02051218 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1380

Last updated 2025-12-30

No results posted yet for this study

Summary

The aim of the trial is to test the hypothesis that the benefit of denosumab is maintained if administered only every 12 weeks as compared to every 4 weeks.

Conditions

Interventions

DRUG

Denosumab (reduced dosing)

3x Denosumab 120mg (XGEVA®) sc. q4w followed by Denosumab 120mg (XGEVA®) sc. q12w

DRUG

Denosumab (standard dosing)

Denosumab 120mg (XGEVA®) sc. q4w

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Roger von Moos, PD MD · Kantonsspital Graubünden

  • Arnoud Templeton, MD · Cantonal Hospital of St. Gallen

  • Silke Gillessen, Prof · Cantonal Hospital of St. Gallen

  • Andreas Müller, MD · Kantonsspital Winterthur KSW

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-16
Primary Completion
2026-06-30
Completion
2028-12-31

Countries

  • Austria
  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT02051218 on ClinicalTrials.gov