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Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT)

NCT00889590 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-01-26

No results posted yet for this study

Summary

This is a multicenter, randomised phase II trial in patients with high risk GCT.

Primary objective:

* Determine if adjuvant zoledronic acid improves the 2 years recurrence rate of 'high risk' GCT as compared to standard care

Secondary objectives:

* Determine the relapse free survival
* Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT

Conditions

  • Giant Cell Tumor of Bone
  • Osteoclastoma

Interventions

DRUG

Zoledronic acid

4 mg, monthly for 3 months followed by a 3-monthly schedule for up to one year after surgery

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • J R Kroep, MD PhD · Leiden University Medical Center (LUMC)

  • P D Dijkstra, MD PhD · LUMC

  • A H Taminiau, MD PhD · LUMC

  • P C Hogendoorn, MD PhD · LUMC

  • H Gelderblom, MD PhD · LUMC

  • N A Hamdy, MD PhD · LUMC

  • S E Papapoulos, MD PhD · LUMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2015-05-31
Completion
2015-07-31

Countries

  • Belgium
  • Netherlands

Study Locations

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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 NCT00889590 on ClinicalTrials.gov