Study of Pyrophosphate Supplement to Reduce Ectopic Calcification in Adults With Pseudoxanthoma Elasticum
Led by Centre Hospitalier Universitaire de Nice · Updated on 2024-05-17
99
Participants Needed
2
Research Sites
37 weeks
Total Duration
AI-Summary
What this Trial Is About
This research investigates Pseudoxanthoma Elasticum PXE, a rare inherited metabolic disorder causing progressive calcification in connective tissues that affects the skin, eyes, blood vessels, and kidneys. PXE results from a gene loss-of-function that lowers plasma levels of inorganic pyrophosphate PPi, an important anti-calcifying molecule. The trial aims to evaluate the safety and effectiveness of daily oral PPi salt supplements compared to placebo in patients with PXE.
Participants in this study will be randomly assigned to receive either PPi supplement capsules or placebo capsules once daily for 12 months. This double-blind trial compares these two groups to assess whether PPi supplementation can impact disease progression. The study is led by the Centre Hospitalier Universitaire de Nice and includes careful monitoring and follow-up during the treatment period.
Throughout the trial, participants will undergo clinical evaluations focusing on arterial calcification scores after 12 months, along with assessments of skin and eye changes and vascular health. The research team will monitor safety, symptoms, and treatment adherence during regular visits. The total participation lasts for the 12-month treatment period, and progress will be measured using detailed clinical observations and imaging.
CONDITIONS
Brief Title
PPI Supplementation to Fight ECtopIc Calcification in PXE
Research Team
G
Georges LEFTHERIOTIS, PUPH
S
Sophie Bonnet
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Patients aged over 18 years and under 65 years, both men and women, with clinically and biologically confirmed PXE (genotype and phenotype) by international criteria
Women of childbearing age must use effective contraception during the study
Patient must be affiliated with social security insurance
Signed informed consent is required
Patient must have no acute complications related or unrelated to PXE at the time of study
You will not qualify if you...
Renal insufficiency defined by renal clearance less than 30 ml/min/1.73 m²
Patients with osteomalacia
Patients with chronic diarrhea lasting more than 1 month
Pregnancy, lactating, or women planning pregnancy within three years
Any other medical condition deemed exclusionary by the Principal Investigator
Use of bisphosphonate within the last 5 years
Hypocalcemia (calcium <2.20 mmol/L and ionized calcium <1.15 mmol/L)
Vitamin D deficiency less than 35 nmol/L
Enrollment in another interventional clinical trial that could interfere
Patients over 18 years protected by law
After correcting hypocalcemia and/or vitamin D deficiency, patients may be re-evaluated for eligibility
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants take either PPI or a placebo daily for 12 months as part of the study treatment.
Regular visits for assessments during the 12 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
The PROPHECI trial: a phase II, double-blind, placebo-controlled, randomized clinical trial for the treatment of pseudoxanthoma elasticum with oral pyrophosphate.