MedTrace Logo

The Prevention of Systemic Ectopic Mineralization in Pseudoxanthoma Elasticum

NCT05832580 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-04-27

No results posted yet for this study

Summary

The goal of this randomized clinical trial is to assess the effect of etidronate on ectopic calcification in relatively young patients with Pseudoxanthoma elasticum. The main question it aims to answer are:

What is the difference in the arterial calcification scores in the legs and the carotid syphon measured on low-dose CT scan after 24 months of treatment compared to baseline between etidronate and placebo.

Participants will be asked to do take etidronate or placebo for 24 months.

Conditions

  • Pseudoxanthoma Elasticum

Interventions

DRUG

Etidronate

Etidronate in capsules of 200 mg or 400 mg.

DRUG

Placebo

Placebo in similar capsules

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2027-03-29
Completion
2027-04-29

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05832580 on ClinicalTrials.gov