REDUCTION OF BONE MORBIDITY USING AN ORAL BISPHOSPHONATE IN FIBROUS DYSPLASIA OF BONE (PROFIDYS Trial) - PROFIDYS Trial

Phase 1

• Conditions: Fibrous dysplasia•Study I: patients with fibrous dysplasia of bone, with bone pain intensity above 3 on a visual analogical scale from 0 to 10.•Study II: patients with fibrous dysplasia of bone, with at least one osteolytic lesion and no current bone pain.; MedDRA version: 9.1Level: PTClassification code 10016664Term: Fibrous dysplasia of bone

• Registration Number: EUCTR2006-003549-18-BE
• Lead Sponsor: Cliniques Universitaires SAINT-LUC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-21
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

· Study I: patients with fibrous dysplasia of bone, with bone pain intensity above 3 on a visual analogical scale from 0 to 10.
· Study II: patients with fibrous dysplasia of bone, with at least one osteolytic lesion and no current bone pain.

Diagnosis of fibrous dysplasia will be asserted by a clinical expert (one of the clinical investigators), on clinical, radiographic and possibly histologic data. A radionuclide bone scan will be performed in each screened patient in order to identify every skeletal dysplastic lesions.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

For both study I and II, the following exclusion criteria will apply:
- patients < 8 years old (no adequate experience in the use of BP before this age)
- patients with other diseases or taking other treatments likely to affect bone metabolism
- patients with malignant diseases or conditions likely to reduce their life expectancy to less than three years
- patients with a history of significant upper gastrointestinal disorders (e.g. oesophagitis and gastroduodenal ulcer), which can interfere with compliance
- kidney failure (creatinin clearance < 25 ml/mn)
- severe liver disease that would affect alkaline phosphatase levels, such as hepatitis, primary biliary sclerosis, and cirrhosis
- history of iritis or uveitis
- untreated rickets or osteomalacia
- allergy to BP
- prior use of bisphosphonates, fluoride
- pregnancy and lactation
- laboratory abnormalities that may be considered as clinically significant by trial physicians

· In both studies, oestrogen replacement therapy will be allowed, and also prior use of calcitonin after a 3 months wash out period.
· Women with childbearing potential must have a negative serum b-HCG pregnancy test, and they must be willing to practice a medically acceptable form of birth control during the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified