RBM 03-54

About this trial

Last updated 4 years ago

Study ID

RBM 03-54

Status

Completed

Type

Interventional

Phase

Phase 2/Phase 3

Placebo

Yes

Accepting

8+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 8 years ago

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.

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

Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone