TEMP trial
- Conditions
- Pseudoxanthoma elasticum, ectopic mineralization
- Registration Number
- NL-OMON27089
- Lead Sponsor
- niversity Medical Center UtrechtDepartment of Vascular MedicineHeidelberglaan 1003584 CX UtrechtThe Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 74
Inclusion Criteria
1.Age 18 and older.
2.Clinical diagnosis of PXE. For the present study the revised criteria for diagnosis of PXE from Plomp et al (2010) (41) will be used. At least two (or more) criteria not belonging to the same (skin, eye, genetic) category should be present for inclusion.
Exclusion Criteria
1. Subjects who are unable or unwilling to sign an informed consent.
2. Severe renal impairment (estimated creatinine clearance/eGFR of <30 ml/min/1.73m2 calculated using CKD-EPI equation).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage change in 18F-NaF uptake in the leg arteries after 12 months of treatment with etidronate 20 mg/kg compared with placebo.
- Secondary Outcome Measures
Name Time Method The percentage change in 18F-NaF uptake after 12 months treatment in other arteries than the leg arteries, ophthalmological changes after 12 months, changes in vascular stiffness after 12 months, changes in bone mineral density after 12 months, changes in quality of life and changes in serum calcium and phosphate.