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

NCT05544669 | Unknown

• 1 other identifier: 8696
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Rendu Osler Disease

Keywords

Rendu-Osler disease; Hypophosphatemia; Injectable iron; Osteomalacia; Carbohydrates; Iron deficiency

Outcome Measures

Primary Outcomes (1)

• Occurrence of a bone crack and/or fracture

  Files analysed retrospectively from January 01, 2018 to December 31, 2022 will be examined

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Major subject (≥ 18 years old) suffering from Rendu-Osler disease and receiving IV iron supplementation

You may qualify if:

• 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

You may not qualify if:

• Subject who expressed their opposition to participating in the study
• Subject under safeguard of justice
• Subject under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Médecine interne - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic; Hypophosphatemia; Osteomalacia; Iron Deficiencies

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Iron Metabolism Disorders

Central Study Contacts

Murielle RONDEAU-LUTZ, MD

CONTACT

33 3 69 55 10 13; murielle.rondeau-lutz@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: August 1, 2022
• Primary Completion: July 21, 2024
• Study Completion: July 21, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

FR (1)