The Prevention of Systemic Ectopic Mineralization in Pseudoxanthoma Elasticum
Recruiting
Phase 3
Interventional Study
Pseudoxanthoma Elasticum
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 50
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 76 (estimated)
- Sponsor
- UMC Utrecht · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* 1\. Be between 18 years and 50 years.
* 2\. Have a definitive diagnosis of PXE according to the Plomp criteria, which confirm a diagnosis of PXE when at least two (or more…
Contacts