Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT01585402
Eligibility Criteria:
* INCLUSION CRITERIA
Inclusion and exclusion criteria are to be assessed at Screening and Baseline prior to starting study drug. Each subject must meet the following criteria to be enrolled in this study:
* Subjects must be diagnosed with ACDC based on genetic tests confirming mutation(s) in NT5E and evidence of lower extremity arterial calcifications.
* Either gender and any ethnic background or race
* Age 18-80 years
* Willingness and legal ability to give and sign informed study consent
* Willingness to travel to NIH and local sites for scheduled protocol studies and treatment
EXCLUSION CRITERIA
Subjects who meet any of the following criteria will be excluded from the study:
* Subjects not diagnosed with ACDC
* Subjects \<18 or \>80 years of age
* Subjects who are unable or unwilling to sign an informed consent
* Severe renal impairment (estimated creatinine clearance/eGFR of \< 30ml/min calculated using CKD-EPI equation)
* Longstanding diabetes mellitus (more than 10 years)
* Known abnormality of the esophagus that would interfere with the passage of the drug
* Known sensitivity to etidronate
* Pregnancy
* Any other medical or social condition that, in the opinion of the Principal Investigator, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01585402
Study Brief:
Protocol Section:
NCT01585402