18F-Fluoride Positron Emission Tomography (PET) in Paget's Disease of Bone

This study has been completed.

Sponsor:

Collaborator:

FNRS (Belgium)

Information provided by:

Université Catholique de Louvain

ClinicalTrials.gov Identifier:

NCT00306046

First received: March 20, 2006

Last updated: NA

Last verified: March 2006

History: No changes posted

Purpose

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.

Condition	Intervention
Paget's Disease of Bone	Drug: Bisphosphonate treatment

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Use of 18F-Fluoride Positron Emission Tomography in the Assessment and Evaluation of Therapy in Monostotic Paget's Disease of Bone

Resource links provided by NLM:

Genetics Home Reference related topics: inclusion body myopathy with early-onset Paget disease and frontotemporal dementia juvenile Paget disease Paget disease of bone

MedlinePlus related topics: Bone Diseases Paget's Disease of Bone

Drug Information available for: Fluorine Fluoride

U.S. FDA Resources

Further study details as provided by Université Catholique de Louvain:

Estimated Enrollment:	20
Study Start Date:	February 2002
Estimated Study Completion Date:	March 2006

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Bisphosphonate therapy within the year prior to the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306046

Locations

Belgium
Rheumatology, Molecular Imaging and Experimental Radiotherapy departments, Saint-Luc University Hospital, Catholic University of Louvain
Brussels, Belgium, 1200

Sponsors and Collaborators

Université Catholique de Louvain

FNRS (Belgium)

Investigators

Principal Investigator:	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
Study Director:	Jean-Pierre DEVOGELAER, MD	Université Catholique de Louvain

More Information

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00306046 History of Changes
Other Study ID Numbers:	3.4528.03 F
Study First Received:	March 20, 2006
Last Updated:	March 20, 2006
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Université Catholique de Louvain:

PETScan
Positron-Emission Tomography
Bisphosphonate
Biochemical Markers
Paget's Disease of Bone (monostotic and polyostotic)

Additional relevant MeSH terms:

Bone Diseases
Osteitis Deformans
Musculoskeletal Diseases
Diphosphonates
Fluorides

Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cariostatic Agents
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013

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