Status:
RECRUITING
PPI Supplementation to Fight ECtopIc Calcification in PXE
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Pseudoxanthoma Elasticum
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Pseudoxanthoma elasticum (PXE) is a rare inherited metabolic disorder (OMIM 264800, frequency 1/25000) characterized by progressive ectopic calcification of connective tissues. PXE mainly affects the ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients (\>18 years and \<65 years), men and women, presenting a clinically and biologically authenticated PXE (genotype + phenotype) according to the international diagnostic criteria (26).
- Efficient contraceptive method in woman of childbearing age at inclusion and during the overall study
- Patient affiliated to a social security insurance
- Signed informed consent
- Patient without acute complication linked or not to the pathology at the time of the study
- NON-INCLUSION CRITERIA
- Renal insufficiency (i.e. defined by a renal clearance \<30ml / min / 1.73 m²)
- Patients with osteomalacia
- Patients with chronic diarrhea (\> 1 month)
- Pregnancy, lactating or fertile women who may wish to become pregnant within three years.
- Any other medical condition that may be considered in the opinion of the Principal Investigator.
- Use of bisphosphonate during last 5 years.
- Hypocalcemia (calcium \<2.20 mmol/L and ionized calcium \<1.15 mmol/L) \*.
- Vitamin D deficiency \<35 nmol/L \*
- Enrollment in another inteventional clinical trial which could interfere with the present study
- patients (\>18 years) protected by law
- After correcting the hypocalcemia and/or vitamin D deficiency, a participant is again suitable for participation in the trial, as long as the participant meets the inclusion criteria.
Exclusion
Key Trial Info
Start Date :
December 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04868578
Start Date
December 13 2022
End Date
September 1 2027
Last Update
May 17 2024
Active Locations (2)
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1
Angers Hospital
Angers, France, 49000
2
Nice Hospital
Nice, France, 06000