NL-OMON32720
Withdrawn
Phase 3
Reduction of Bone Morbidity using Oral Bisphosphonate in Fibrous Dysplasia of Bone - PROFIDYS
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- there isn't any
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 15
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Study I: Patients with fibrous dysplasia with painful bone lesions of intensity higher than 3 on a visual analog scale from 0 to 10\.
- •Study II: Patients with fibrous dysplasia with at least on osteolytic lesion and no current bone pain.
Exclusion Criteria
- •patients younger than 18 years (for the Dutch protocol)
- •patients with other bone diseases or receiving treatments likely to affect bone metabolism
- •renal insufficiency (CCR \<25 ml/min)
- •liver disease
Outcomes
Primary Outcomes
Not specified
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