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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00306046
First Posted: March 22, 2006
Last Update Posted: March 22, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
FNRS (Belgium)
Information provided by:
Université Catholique de Louvain
  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: None (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

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 20, 2006
First Posted: March 22, 2006
Last Update Posted: March 22, 2006
Last Verified: March 2006

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
Fluorides
Diphosphonates
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Bone Density Conservation Agents