Rendu Osler DiseaseOS-LERETRONCT05544669
Calcium-phosphate Complications Induced by IV Iron Supplementation in Patients With Rendu-Osler Disease
An observational study of Rendu Osler Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rendu Osler Disease
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2022to 21 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major subject (≥ 18 years old) suffering from Rendu-Osler disease and receiving IV iron supplementation
Who may be able to join
- 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
Who cannot join
- Subject who expressed their opposition to participating in the study
- Subject under safeguard of justice
- Subject under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Médecine interne - CHU de Strasbourg - France
Strasbourg, 67091
Murielle RONDEAU-LUTZ, MD, 33 3 69 55 10 13, murielle.rondeau-lutz@chru-strasbourg.fr
Massimo RONDEAU-LUTZ, MD
About this study
Official title: Study of Calcium-phosphate Complications Induced by the Administration of IV Iron Supplementation in Patients With Rendu-Osler Disease
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
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic, Hypophosphatemia, Osteomalacia, Iron Deficiencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a bone crack and/or fracture
Measured: Files analysed retrospectively from January 01, 2018 to December 31, 2022 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Aug 2022
- Primary completion21 Jul 2024 (estimated)
- Study completion21 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rendu Osler DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544669
- Sponsor's protocol ID
- 8696
- Acronym
- OS-LERETRO
- Status last verified
- Dec 2023
- First submitted
- 13 Sep 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Calcium-phosphate Complications Induced by the Administration of IV Iron Supplementation in Patients With Rendu-Osler Disease
- ClinicalTrials.gov ID
- NCT05544669
- Acronym / sponsor ID
- OS-LERETRO / 8696
- Conditions
- Rendu Osler Disease
- Keywords
- Rendu-Osler disease, Hypophosphatemia, Injectable iron, Osteomalacia, Carbohydrates, Iron deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 21 Jul 2024 (estimated)
- Study completion
- 21 Jul 2024 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥ 18 years old) suffering from Rendu-Osler disease and receiving IV iron supplementation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Subject who expressed their opposition to participating in the study
- Subject under safeguard of justice
- Subject under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of a bone crack and/or fracture
Time frame: Files analysed retrospectively from January 01, 2018 to December 31, 2022 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rendu Osler Disease, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Murielle RONDEAU-LUTZ, MD (33 3 69 55 10 13, murielle.rondeau-lutz@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a bone crack and/or fracture (time frame: Files analysed retrospectively from January 01, 2018 to December 31, 2022 will be examined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.