Loading clinical trials...
Loading clinical trials...
This trial is intended to test the efficacy of an oral bisphosphonate (risedronate) to decrease bone pain and improve radiological aspect in fibrous dysplasia of bone.
In open pilot studies, it has been suggested that bisphosphonates may alleviate bone pain and help decrease the surface of osteolytic lesion in patients with fibrous dysplasia of bone (FD). So, in this randomized placebo controlled trial, we test the hypothesis that the bisphosphonate risedronate reduces bone pain in patients with FD (study I, one year duration) and decrease osteolytic lesions (study II, three years duration). Patients will take risedronate during 2 months courses, every 6 months or a matching placebo. Dosage will be : 30mg tablet/day for adults and 5mg tablet x 2,4 according to the age and weight of the child. All participants will receive calcium and vitamin D. All patients with renal phosphate wasting will receive an oral phosphate supplement.
Age
8 - No limit years
Sex
ALL
Healthy Volunteers
No
Cliniques Universitaires Saint Luc
Brussels, Belgium
Hopital E Herriot
Lyon, France
Hopital Lariboisiere
Paris, France
Hopital Cochin
Paris, France
Hospital Benjamin Franklin
Berlin, Germany
Cologne Clinical Centre
Cologne, Germany
Heildeberg Clinical Centre
Heidelberg, Germany
Leids Universitair Medisch Centrum
Leiden, Netherlands
Start Date
July 22, 2007
Primary Completion Date
December 1, 2017
Completion Date
December 7, 2017
Last Updated
August 30, 2021
80
ACTUAL participants
risedronate
DRUG
placebo
DRUG
risedronate
DRUG
placebo
DRUG
Lead Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions