Reduction of Bone Morbidity using Oral Bisphosphonate in Fibrous Dysplasia of Bone
Phase 3
Withdrawn
- Conditions
- there isn't any1002839610005959
- Registration Number
- NL-OMON32720
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 15
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Study I: Intensity of bone pain assessed by visual analog scale (VAS); safety<br /><br>and tolarability of treatment<br /><br><br /><br>Study II: radiological improvement; safety and tolerability of treatment</p><br>
- Secondary Outcome Measures
Name Time Method <p>Study I: Decrease of the number of painful lesions; decrease in the consumption<br /><br>of analgesics, improvement of the quality of life (S-36; AIMS2-short form);<br /><br>decrease in biochemical markes of bone turnover; radiographic improvement of<br /><br>the lesions; increase in bone mineral density in patients with a hip<br /><br>localization.<br /><br><br /><br>Study II: Improvement in the quality of life; decrease in biochemical markers<br /><br>of bone turnover; increase in bone mineral density in patinets with a hip<br /><br>localization.</p><br>