Reduction of Bone Morbidity Using an Oral Bisphosphonate in Fibrous Dysplasia of Bone - PROFIDYS
- Conditions
- Fibrous Dysplasia of Bone, MedDRA 8.0, 10016664
- Registration Number
- EUCTR2006-003549-18-NL
- Lead Sponsor
- ZonMw
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 156
Study I: Patients with fibrous dysplasia with painful lesions of intensity above 3 on a visual scale analog from 0 to 10.
Study II: Patients with fibrous dysplasia of bone with at least one osteolytic lesion and no current bone pain.
Are the trial subjects under 18? no
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
patients yournger than 8 years
patients with other diseases or receiving treatments likely to affect bone metabolism
patients with significant upper gastrointestinal disorders
renal insufficiency (creatinine clearance <25 ml/min)
liver disease
in both studies estrogen replacement therapy will be allowed
women at child bearing age should have a negative pregnancy test and be willing to use a medically acceptable method of contraception
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method