Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT05544669
Status:
RECRUITING
Last Update Posted:
2023-12-19
First Post:
2022-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Calcium-phosphate Complications Induced by IV Iron Supplementation in Patients With Rendu-Osler Disease
Sponsor:
University Hospital, Strasbourg, France
Organization:
Study Overview
Official Title:
Study of Calcium-phosphate Complications Induced by the Administration of IV Iron Supplementation in Patients With Rendu-Osler Disease
Status:
RECRUITING
Status Verified Date:
2023-12
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:
OS-LERETRO
Brief Summary:
Hypophosphatemia induced by treatments with injectable iron is a frequent side effect already reported during marketing. Situations of osteomalacia secondary to these hypophosphatemias are rarer and reported in the form of case reports in the literature. Hypophosphatemia in this context is attributed to an excess of FGF-23 (defect of degradation linked to carbohydrates in martial preparations) with renal leakage of phosphate.
Rendu-Osler disease (ROM) is an autosomal dominant genetic disease, favoring the formation of vascular malformations, including nasal and digestive telangiectasias causing repeated bleeding, even hemorrhages. Iron deficiency is frequent and profound there, and oral martial treatments are often insufficient to compensate for these losses. Regular iron infusions, to avoid transfusions, are often necessary.
Rendu-Osler disease (ROM) is an autosomal dominant genetic disease, favoring the formation of vascular malformations, including nasal and digestive telangiectasias causing repeated bleeding, even hemorrhages. Iron deficiency is frequent and profound there, and oral martial treatments are often insufficient to compensate for these losses. Regular iron infusions, to avoid transfusions, are often necessary.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: