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Calcium-phosphate Complications Induced by IV Iron Supplementation in Patients With Rendu-Osler Disease

NCT ID: NCT05544669

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-07-21

Brief Summary

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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.

Detailed Description

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Conditions

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Rendu Osler Disease

Keywords

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Rendu-Osler disease Hypophosphatemia Injectable iron Osteomalacia Carbohydrates Iron deficiency

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Major subject (≥ 18 years old)
* suffering from Rendu-Osler disease and receiving IV iron supplementation
* Subject not objecting, after information, to the reuse of their data for scientific research purposes

Exclusion Criteria

* Subject who expressed their opposition to participating in the study
* Subject under safeguard of justice
* Subject under guardianship or curatorship
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Médecine interne - CHU de Strasbourg - France

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Murielle RONDEAU-LUTZ, MD

Role: CONTACT

Phone: 33 3 69 55 10 13

Email: [email protected]

Facility Contacts

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Murielle RONDEAU-LUTZ, MD

Role: primary

Other Identifiers

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8696

Identifier Type: -

Identifier Source: org_study_id