NCT00889590

Brief 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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2008

Longer than P75 for phase_2

Geographic Reach
2 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

6.4 years

First QC Date

April 28, 2009

Last Update Submit

January 25, 2016

Conditions

Giant Cell Tumor of BoneOsteoclastoma

Keywords

GCTBisfosfonates

Outcome Measures

Primary Outcomes (1)

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

    4 years

Secondary Outcomes (2)

  • Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT

    4 years

  • Determine the relapse free survival

    4 years

Study Arms (2)

Zoledronic acid

EXPERIMENTAL

Adjuvant zoledronic acid

Drug: Zoledronic acid

Control

NO INTERVENTION

Standard care

Interventions

Zoledronic acidDRUG

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

Also known as: Zometa
Zoledronic acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent
  • Male or female \> 18 years of age
  • Histologically proven GCT treated with surgery
  • High risk GCT defined as minimal one or more of the following:
  • Recurrent GCT
  • GCT located in the pelvis, sacrum, spine, distal ulna or growth in soft tissue
  • GCT grade III
  • Pathological fracture in GCT
  • Absence of local adjuvant therapy (cryosurgery or phenol instillation)
  • Neutrophils \> 1.5x109/L, platelets \> 100x109/L, and Hb \> 6 mmol/l
  • Bilirubin level \< 1.5 x ULN
  • ASAT and ALAT \< 2.5 x ULN
  • Adequate renal function as defined by: serum creatinine clearance \> 60 cc/min
  • Expected adequacy of follow-up

You may not qualify if:

  • Unresectable or metastatic GCT and grade IV GCT
  • Prior bisphosphonate usage, except preoperative treatment with zoledronic acid up to 3 months before surgery
  • Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
  • Known hypersensitivity reaction to any of the components of the treatment
  • Pregnancy or lactating
  • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University hospital Gent

Ghent, 9000, Belgium

Location

Academic Medical Center, University of Amsterdam

Amsterdam, 1100DD, Netherlands

Location

Groningen University Medical Center

Groningen, 9700 RB, Netherlands

Location

Leiden University Medical Center

Leiden, 2300RC, Netherlands

Location

Related Publications (1)

  • Lipplaa A, Kroep JR, van der Heijden L, Jutte PC, Hogendoorn PCW, Dijkstra S, Gelderblom H. Adjuvant Zoledronic Acid in High-Risk Giant Cell Tumor of Bone: A Multicenter Randomized Phase II Trial. Oncologist. 2019 Jul;24(7):889-e421. doi: 10.1634/theoncologist.2019-0280. Epub 2019 Apr 30.

    PMID: 31040253DERIVED

MeSH Terms

Conditions

Giant Cell Tumor of Bone

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Giant Cell TumorsNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Bone Tissue

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • J R Kroep, MD PhD

    Leiden University Medical Center (LUMC)

    PRINCIPAL INVESTIGATOR

  • P D Dijkstra, MD PhD

    LUMC

    STUDY DIRECTOR

  • A H Taminiau, MD PhD

    LUMC

    STUDY DIRECTOR

  • P C Hogendoorn, MD PhD

    LUMC

    STUDY DIRECTOR

  • H Gelderblom, MD PhD

    LUMC

    STUDY DIRECTOR

  • N A Hamdy, MD PhD

    LUMC

    STUDY DIRECTOR

  • S E Papapoulos, MD PhD

    LUMC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

April 28, 2009

First Posted

April 29, 2009

Study Start

December 1, 2008

Primary Completion

May 1, 2015

Study Completion

July 1, 2015

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

BE(1)NL(3)