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:


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
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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:
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 July 22, 2014