Actively Recruiting
The Prevention of Systemic Ectopic Mineralization in Pseudoxanthoma Elasticum
Led by UMC Utrecht · Updated on 2023-04-27
76
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Prevention of Systemic Ectopic Mineralization in Pseudoxanthoma Elasticum
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 18 years and 50 years old
- Have a definitive diagnosis of PXE according to the Plomp criteria, confirmed by at least two criteria from different categories (skin, eye, genetic)
- Fertile women must use adequate contraception
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Pregnant, lactating, or fertile women planning pregnancy within three years
- Estimated glomerular filtration rate below 30 ml/min/1.73m2
- Known esophagus abnormalities interfering with drug passage
- Chronic diarrhea lasting more than 1 month
- Known osteomalacia
- Hypocalcemia (calcium below 2.20 mmol/L corrected for albumin)
- Vitamin D deficiency (below 35 nmol/L)
- Use of bisphosphonates in the past 5 years
- Known sensitivity to etidronate
- Any other medical or social condition that may pose risk or affect study data interpretation as judged by the Principal Investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
Research Team
W
Wilko Spiering, MD, PhD
CONTACT
I
Iris Harmsen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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