Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

• Status: Completed
• Trial end date: 2017-12-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Collaborators: Charite University, Berlin, Germany; Cliniques universitaires Saint-Luc- Université Catholique de Louvain; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Etidronic Acid; Risedronate Sodium; Risedronic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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