NCT00306046

Brief Summary

18 F-fluoride Positron emission tomography (PET) is able to demonstrate and quantify the metabolic activity locally in the skeleton (1). This technique should, therefore, also be able to demonstrate a dramatic decrease in the metabolic activity in localized monostotic Paget's disease lesions after therapy. In this condition, indeed, the usual biological markers may be unhelpful to assess the efficacy of therapy, because they are usually comprised in the normal range for single pagetic localizations, even before therapy (2). The main purpose of this trial is to assess the early and long term response of pagetic bone to bisphosphonate therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2002

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
Last Updated

March 22, 2006

Status Verified

March 1, 2006

First QC Date

March 20, 2006

Last Update Submit

March 20, 2006

Conditions

Paget's Disease of Bone

Keywords

PETScanPositron-Emission TomographyBisphosphonateBiochemical MarkersPaget's Disease of Bone (monostotic and polyostotic)

Interventions

Bisphosphonate treatmentDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a monostotic form of PDB (as attested by plain X-rays and 99mTc MDP bone scintigraphy)
  • Bone pain linked to Paget's disease itself

You may not qualify if:

  • Bisphosphonate therapy within the year prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology, Molecular Imaging and Experimental Radiotherapy departments, Saint-Luc University Hospital, Catholic University of Louvain

Brussels, 1200, Belgium

Location

Related Publications (1)

  • Installe J, Nzeusseu A, Bol A, Depresseux G, Devogelaer JP, Lonneux M. (18)F-fluoride PET for monitoring therapeutic response in Paget's disease of bone. J Nucl Med. 2005 Oct;46(10):1650-8.

    PMID: 16204715BACKGROUND

MeSH Terms

Conditions

Osteitis Deformans

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • Adrien T. NZEUSSEU, MD

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

  • Max LONNEUX, MD, PhD

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

  • Johanne INSTALLE, MD

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

  • Anne BOL, PhD

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

  • Geneviève DEPRESSEUX

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

  • Jean-Pierre DEVOGELAER, MD

    Université Catholique de Louvain

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2006

First Posted

March 22, 2006

Study Start

February 1, 2002

Study Completion

March 1, 2006

Last Updated

March 22, 2006

Record last verified: 2006-03

Locations

BE(1)