The Prevention of Systemic Ectopic Mineralization in Pseudoxanthoma Elasticum
NCT05832580, Phase 3, Recruiting, UMC Utrecht
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Prevention of Systemic Ectopic Mineralization in Pseudoxanthoma Elasticum | ClinicalTrials.gov |
| NCT number | NCT05832580 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 76 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | UMC Utrecht | ClinicalTrials.gov |
| Conditions | Pseudoxanthoma Elasticum | ClinicalTrials.gov |
| Interventions | Etidronate, Placebo | ClinicalTrials.gov |
| First posted | 2023-04-27 | ClinicalTrials.gov |
| Last updated | 2023-04-27 | ClinicalTrials.gov |
Registered outcomes 30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Arterial calcification | 24 months. | The difference in arterial calcification volume measured (uL) on CT-scans between the etidronate and placebo group 24 months. | ClinicalTrials.gov |
| Secondary | Ophtalmology: Visual acuity | 24 months. | Difference in visual acuity at phtalmologic exam. | ClinicalTrials.gov |
| Secondary | Ophtalmology: Contrast sensitivity. | 24 months. | Difference in contrast sensitivity at ophtalmologic exam. | ClinicalTrials.gov |
| Secondary | Ophtalmology: Reflectivity of Bruch's membrane | 24 months. | Difference in normalized reflectivity in Bruch's membrane as measured with SD-optical coherence tomography, between the etidronate and placebo group after 24 months. | ClinicalTrials.gov |
| Secondary | Ophtalmology: Length of angioid streaks. | 24 months. | Length of angioid streaks in the fundus, between the etidronate and placebogroup after 24 months. | ClinicalTrials.gov |
| Secondary | Ophtalmology: Area of angioid streaks. | 24 months. | Amount of area coverd by angioid streaks in the fundus, between the etidronate and placebogroup after 24 months. | ClinicalTrials.gov |
| Secondary | Ophtalmology: Area of atrophy | 24 months. | The area of artophy on near-Infrared between etidronate an de placebogroup after 24 months. | ClinicalTrials.gov |
| Secondary | Intra cranial velocity pulsatility index on MRI | 24 months. | Difference in the intracranial velocity pulsatility index as measured with MRI, between the etidronate and placebo group after 24 months. | ClinicalTrials.gov |
| Secondary | Elastin degradation of the skin | 24 months. | Difference in the amount of elastin degradation in the skin in observation of skin biopsies, between the etidronate and placebo group after 24 months. | ClinicalTrials.gov |
| Secondary | Calcification of the skin | 24 months. | Difference in the amount of calcified tissue in the skin in observation of skin biopsies, between the etidronate and placebo group after 24 months. | ClinicalTrials.gov |
| Secondary | inorganic pyrophosphate | 24 months. | Difference in plasma inorganic pyrophosphate between the etidronate and placebo group after 24 months. | ClinicalTrials.gov |
| Secondary | serum desmosine | 24 months. | Difference in serum desmosine, between the etidronate and placebo group after 24 months. | ClinicalTrials.gov |
| Secondary | Incidence of MACE | 24 months. | Difference in occurence of major adverse cardiovascular events (stroke, TIA, myocardial infarction or cardiovascular death) between the etidronate and placebo group after 24 months. | ClinicalTrials.gov |
| Secondary | EQ-5D | 24 months. | Difference in reported quality of life, as measured with the EQ-5D, between the etidronate and placebo group after 24 months. | ClinicalTrials.gov |
| Secondary | Cognitive Function 15 Words test | 24 months. | Difference in scores 15 words test between the etidronate and placebo group after 24 months. | ClinicalTrials.gov |
| Secondary | Cognitive Function STROOP | 24 months. | Difference in scores on the STROOP test between the etidronate and placebo group after 24 months. | ClinicalTrials.gov |
| Secondary | Cognitive functioning Trailmaking test | 24 months. | Difference in scores on trailmaking test between the etidronate and placebo group after 24 months. | ClinicalTrials.gov |
| Secondary | Cognitive functioning Brixton test | 24 months. | Difference in scores on brixton test between the etidronate and placebo group after 24 months. | ClinicalTrials.gov |
| Secondary | Cognitive Function semantic fluency | 24 months. | Difference in number of words named in the sematic fluency test between the etidronate and placebo group after 24 months. | ClinicalTrials.gov |
| Secondary | Safety: Anti VGEF use | 24 months. | Difference in number of anti-VEGF injections used, between the etidronate and placebo group after 24 months. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 41131563 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Secondary outcome | ConductCognition |
| Rule Anticipation Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)