NCT02996734

Brief Summary

The purpose of this project is to present the outcomes of patients with giant cell tumor of bone (GCTB) who were treated with surgery and/or medical treatment in a single institution.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
412

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Status
completed

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

April 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

December 15, 2016

Last Update Submit

December 21, 2016

Conditions

Giant Cell Tumor of Bone

Keywords

bone tumorsgiant cell tumortreatment

Outcome Measures

Primary Outcomes (1)

  • local recurrence rate after surgical and medical treatment

    within the first 36 months after surgery

Interventions

curettage and resectionPROCEDURE

the investigators analyzed patients with giant cell tumor of bone who underwent curettage or resection with or without denosumab administration

Also known as: denosumab

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with giant cell tumor of bone treated in a single institution

You may qualify if:

  • giant cell tumors of the extremities

You may not qualify if:

  • giant cell tumors of the spine and pelvis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tsukamoto S, Mavrogenis AF, Leone G, Righi A, Akahane M, Tanzi P, Kido A, Honoki K, Tanaka Y, Donati DM, Errani C. Denosumab does not decrease the risk of lung metastases from bone giant cell tumour. Int Orthop. 2019 Feb;43(2):483-489. doi: 10.1007/s00264-018-4085-6. Epub 2018 Aug 11.

    PMID: 30099641DERIVED

MeSH Terms

Conditions

Giant Cell Tumor of BoneBone NeoplasmsGiant Cell Tumors

Interventions

CurettageDenosumab

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Bone TissueNeoplasms by SiteBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Davide Donati, MD

    Istituto Ortopedico Rizzoli

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD; PhD.

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 19, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 22, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

publish a manuscript in international medical journal