Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445575
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2007-03-08
Brief Title:
Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
Official Title:
Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROFIDYS
Brief Summary:
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
Detailed Description:
In open pilot studies it has been suggested that bisphosphonates may alleviate bone pain and help decrease the surface of osteolytic lesion in patients with fibrous dysplasia of bone FD So in this randomized placebo controlled trial we test the hypothesis that the bisphosphonate risedronate reduces bone pain in patients with FD study I one year duration and decrease osteolytic lesions study II three years duration Patients will take risedronate during 2 months courses every 6 months or a matching placebo Dosage will be 30mg tabletday for adults and 5mg tablet x 24 according to the age and weight of the child All participants will receive calcium and vitamin D All patients with renal phosphate wasting will receive an oral phosphate supplement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AFSSAPS 060834 | None | None | None |