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NCT01585402 · ClinicalTrials.gov registry record · Phase 2
Etidronate for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
A Phase 2 study of Arterial Calcification and CD73 Deficiency, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT01585402: Completed Phase 2 study of Arterial Calcification and CD73 Deficiency, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT01585402 is a Phase 2 study of Arterial Calcification and CD73 Deficiency that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01585402, a Phase 2 study of Arterial Calcification and CD73 Deficiency, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * Arterial Calcifications due to Deficiency in CD73 (ACDC) is a rare genetic disease. People with ACDC develop calcification in the arteries of the lower extremities as well as calcium deposit in the joints of the fingers, wrists, ankles and feet. The lower extremities calcification causes claudication because of severe ischemia requiring at time revascularization procedures. the calcium deposits in the joints causes severe debilitating pain in the hands and feet. Currently, there are no standard treatments for ACDC. * Etidronate is a bisphosphonate that interferes with bone metabolism. It is approved to treat Paget's disease, a condition in which the bones are soft and weak and may be deformed, painful, or easily broken. It is also used to treat high blood calcium levels. Researchers want to see if it can be used to treat the calcifications of ACDC and improve pain and blood flow in the lower extremities and arthritic pain of the hands and feet. Objectives: \- To see if etidronate is a safe and effective treatment for ACDC. Eligibility: \- People between 18 and 80 years of age who have been diagnosed with ACDC. Design: * Participants will be screened with a physical exam and medical history. They will also have imaging studies, including CT scan of the lower extremities, x-rays and DEXA bone scans, before starting treatment. Blood and urine samples will be collected. An exercise tolerance test will also be given and ABI (ankle brachial index will be measured. * Participants will take etidronate by mouth once a day for 14 days every 3 months. They will be assigned an individualized 6- month drug schedule to follow. * Participants will have regular study visits throughout the treatment period. These visits will involve imaging studies, full dental exams, and blood and urine tests. Participants will also have exercise tolerance tests and ABIs measured. * Participants may also provide tissue samples for further study. * Treatment will continue for up
Primary Outcome
Ankle-brachial Index (ABI) at rest at pre-treatment, on-treatment and post-treatment of etidronate in participants diagnosed with ACDC. ABI is the ratio of the blood pressure in the lower and upper extremities obtained by dividing the blood pressure in an artery of the ankle by the blood pressure in an artery of the arm. Interpreting ABI values indicate the amount of arterial disease. Interpretation is as follows: \> or equal to 1.3 is noncompressible vessel, \> or equal to 1.0 is normal, 0.9 t
Conditions Studied
Interventions
- DRUG Etidronate
- DEVICE MRI Scan
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2012-08-20 |
| Est. Completion | 2021-08-06 |
| Phase | Phase 2 |
What the finished NCT01585402 record still lists
NCT01585402 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Arterial Calcification appearing as the primary indexed condition, and to 2 interventions - of which Etidronate is the first listed.
NCT01585402 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01585402 about?
NCT01585402 is a clinical study titled "Etidronate for Arterial Calcifications Due to Deficiency in CD73 (ACDC)". Background: * Arterial Calcifications due to Deficiency in CD73 (ACDC) is a rare genetic disease. People with ACDC develop calcification in the arteries of the lower extremities as well as calcium deposit in the joints of the fingers, wrists, ankles and feet. The lower extremities calcification cau...
What is the current status of trial NCT01585402?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2012-08-20. Estimated completion is 2021-08-06.
What conditions does trial NCT01585402 study?
This clinical trial studies the following conditions: Arterial Calcification, CD73 Deficiency.
What interventions are being tested in trial NCT01585402?
The interventions under investigation include: Etidronate (DRUG), MRI Scan (DEVICE).
Who is sponsoring clinical trial NCT01585402?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01585402 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
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