Clinical Trial: 18F-Fluoride Positron Emission Tomography (PET) in Paget's Disease of Bone
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Use of 18F-Fluoride Positron Emission Tomography in the Assessment and Evaluation of Therapy in Monostotic Paget's Disease of Bone
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.
Detailed Summary:
I. Background of the subject:
Paget’s disease of bone is a condition characterized by a focal exuberant increase in bone remodeling, resulting in a number of important architectural abnormalities, potentially leading to bone deformity and bone fragility. This condition may be polyostotic or monostotic. Biological markers of bone remodeling, mainly alkaline phosphatase and markers of bone resorption such as urinary hydroxyproline, are commonly utilized to assess Paget’s disease activity.
However, a monostotic Paget’s disease is most frequently accompanied by biological markers still in the normal range (1). Conventional 99mTc MDP bone scan is able to localize the lesion. However, the changes observed with this technique after therapy and when the disease recurs do not help much to guide the clinician (3). Indeed, there can be some improvement on the conventional bone scans whereas on the X-ray films, worsening of the pagetic lesions might simultaneously be observed (4). The recurrence of the condition could also be missed by conventional bone scans (4). Therefore, PET scan using 18 Fluoride should by its metabolic approach be able to demonstrate the local activity of Paget’s disease, to assess the efficacy of active drugs and to evidence the local recurrence of the disease, better than the conventional existing techniques.
II. Experimental approach and methods
- 20 patients suffering from a Paget’s disease of bone (polyostotic: n = 6; monostotic: n = 14) will be studied prior to and after 1, 6, and 12 months of bisphosphonate therapy. The polyostotic cases will serve to the preliminary feasibility study. A localized Paget’s disease will include isolated Pagetic
Sponsor: Université Catholique de Louvain
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Université Catholique de Louvain
Dates:
Date Received: March 20, 2006
Date Started: February 2002
Date Completion: March 2006
Last Updated: March 20, 2006
Last Verified: March 2006
