Status:
COMPLETED
Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
Fibrous Dysplasia of Bone
Eligibility:
All Genders
8+ years
Phase:
PHASE2
PHASE3
Brief Summary
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.
Detailed Description
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 thi...
Eligibility Criteria
Inclusion
- Study I: patients with FD, with bone pain intensity above 3 on visual analogical scale from 0 to 10
- Study II: patients with FD with at least one osteolytic lesion and no current bone pain
Exclusion
- patients \< 8 years old
- other diseases affecting bone metabolism
- patients with malignant diseases or other conditions likely to reduce their life expectancy to less than 3 years
- patients with history of significant upper gastrointestinal disorders
- renal failure (creatinine clearance \< 25 ml/mn)
- severe liver disease
- history of iritis or uveitis
- rickets or osteomalacia
- allergy to bisphosphonates
- pregnancy or lactation
- prior treatment with a bisphosphonate
- laboratory abnormalities that may be considered as clinically significant by trial physicians
Key Trial Info
Start Date :
July 22 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2017
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00445575
Start Date
July 22 2007
End Date
December 7 2017
Last Update
August 30 2021
Active Locations (8)
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1
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
2
Hopital E Herriot
Lyon, France, 69437
3
Hopital Lariboisiere
Paris, France, 75475
4
Hopital Cochin
Paris, France, 75679