Trial · NCT01585402
Etidronate for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
NCT01585402, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2022-10-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Etidronate for Arterial Calcifications Due to Deficiency in CD73 (ACDC). Trials, record NCT01585402. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01585402
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Etidronate for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
- NCT number
- NCT01585402
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Arterial Calcification, CD73 Deficiency
- Interventions
- Etidronate, MRI Scan
- First posted
- 2012-04-25
- Last updated
- 2022-10-04
- Results first posted
- 2022-10-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ankle-brachial Index at Rest at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment) | 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 to 0.99 is borderline or equivocal, 0.7 to 0.89 is mild arterial disease, 0.5 to 0.69 is moderate arterial disease, and \<0.5 is severe arterial disease. |
| Primary | Ankle-brachial Index After Exercise at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment) | Ankle-brachial Index (ABI) after exercise 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 to 0.99 is borderline or equivocal, 0.7 to 0.89 is mild arterial disease, 0.5 to 0.69 is moderate arterial disease, and \<0.5 is severe arterial disease. |
| Primary | Computed Tomography Calcium Score of Lower Extremities at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment) | Computed tomography (CT) Calcium Score of lower extremities at pre-treatment, on-treatment and post-treatment of etidronate in participants diagnosed with ACDC. According to Cleveland Clinic, a calcium score uses CT to detect calcium deposits in the coronary arteries of the heart. A higher coronary calcium score indicates a higher chance of significant narrowing in the coronary arteries and a higher risk of future heart attack. The Calcium Score range is as follows: zero is no evidence of Coronary Artery Disease (CAD), 1-10 is minimal evidence of CAD, 11-100 is mild evidence of CAD, 101-400 is moderate evidence of CAD and over 400 is extensive evidence of CAD. We applied the same concept to the arteries of the lower extremities. ACDC participants have an overwhelming amount of calcification in the lower extremity vasculature therefore their Calcium Scores are all out of range at baseline and during the study period. |
| Secondary | Changes in Hand Joint Calcification Based on Hand X-ray Before and During Etidronate in Participants Diagnosed With ACDC | Up to 2 years (pre-treatment), 3 years (on-treatment) | Changes in hand joint calcification are based on bilateral hand x-ray before and during Etidronate in participants diagnosed with ACDC as a composite score provided by a radiologist measuring calcium deposit volume (mm\^3), calcium deposit density and number of calcifications observed in each finger joint. This is a new scoring system created by our team for the research study, so it has never been used before and healthy volunteer data is not available. However, healthy volunteers would be expected to have no joint calcifications in their hands, in sharp contrast with what we observe in ACDC patients. Density is subjectively defined as 0 equals no calcification, 1 equals barely visible, 2 equals visible with faint margins, 3 equals moderately dense and 4 equals fully dense. The range for the hand X-ray calcification score in this cohort was 288 (minimum) to 863 (maximum). |
| Secondary | Simple Disease Activity Index Score at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment) | Simple Disease Activity Index (SDAI) score at pre-treatment, on-treatment and post-treatment of Etidronate in Participants Diagnosed With ACDC. The SDAI is a standard rheumatoid arthritis scores that provide treatment outcome measures on patient joint swelling and pain as well as participants ability to perform daily activity tasks. The SDAI is the sum of five parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity and level of C-Reactive Protein (mg/dl, normal \<1 mg/dl). Total score is defined as: remission as less than 3, low disease activity is between 3 to 11, moderate disease activity is between 11 to 26 and high disease activity is greater than 26. Maximum score possible score is 86 with high disease activity. |
| Secondary | Duke Activity Status Index Score at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment) | Duke Activity Status Index (DASI) score at pre-treatment, on-treatment and post-treatment of Etidronate in Participants Diagnosed With ACDC. The DASI is an assessment tool used to evaluate the functional capacity of patients with cardiovascular disease (CVD), such as coronary artery disease, myocardial infarction, and heart failure. Positive responses are summed up to get a total score, which ranges from 0 to 58.2. Higher scores would indicate a higher functional capacity. |
| Secondary | Peak Metabolic Equivalents (METS) During Treadmill Test at Pre-treatment, On-treatment and Post- Treatment of Etidronate in Participants Diagnosed With ACDC | Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment) | Peak Metabolic Equivalents (METS) During Treadmill Test at Pre-treatment, On-treatment and Post- treatment of Etidronate in Participants Diagnosed With ACDC A symptom-limited treadmill progressive test (Gardner Protocol) with gradual increase in grade will be performed in accordance with standard practice to evaluation exercise capacity and pain on exertion in subjects with decreased peripheral arterial perfusion. This test will use a constant speed of 2 mph and gradual increase in grade of 2% every 2 minutes beginning at 0% grade. METS is a measure of how able a person is to tolerate exercise. No scales exists. METS is calculated by = METs x 3.5 x (your body weight in kilograms) / 200 = calories burned per minute. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ankle-brachial Index at Rest at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment) | One participant received 11 drug cycles (not 12 cycles) due to discontinuation of the drug by the manufacturer. Participants that underwent lower limb revascularization procedures, measurements obtained after the procedure dates were excluded from analysis. | score on a scale | MEAN |
| PRIMARY | Ankle-brachial Index After Exercise at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment) | One participant received 11 drug cycles (not 12 cycles) due to discontinuation of the drug by the manufacturer. Participants that underwent lower limb revascularization procedures, measurements obtained after the procedure dates were excluded from analysis. | score on a scale | MEAN |
| PRIMARY | Computed Tomography Calcium Score of Lower Extremities at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment) | One participant received 11 drug cycles (not 12 cycles) due to discontinuation of the drug by the manufacturer. Participants that underwent lower limb revascularization procedures, measurements obtained after the procedure dates were excluded from analysis. ACDC participants have an overwhelming amount of calcification in the lower extremity vasculature therefore their Calcium Scores are all out of range at baseline and during the study period. | score on a scale | MEAN |
| SECONDARY | Changes in Hand Joint Calcification Based on Hand X-ray Before and During Etidronate in Participants Diagnosed With ACDC | Up to 2 years (pre-treatment), 3 years (on-treatment) | One participant received 11 drug cycles (not 12 cycles) due to discontinuation of the drug by the manufacturer. | score on a scale | MEAN |
| SECONDARY | Simple Disease Activity Index Score at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment) | One participant received 11 drug cycles due to discontinuation of the drug by the manufacturer. | score on a scale | MEAN |
| SECONDARY | Duke Activity Status Index Score at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment) | One participant received 11 drug cycles (not 12 cycles) due to discontinuation of the drug by the manufacturer. | score on a scale | MEAN |
| SECONDARY | Peak Metabolic Equivalents (METS) During Treadmill Test at Pre-treatment, On-treatment and Post- Treatment of Etidronate in Participants Diagnosed With ACDC | Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment) | One participant received 11 drug cycles (not 12 cycles) due to discontinuation of the drug by the manufacturer. | Metabolic Equivalents | MEAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ankle-brachial Index at Rest at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | Left Side Pre-Treatment at Rest | 0.5741 | 95% Confidence Interval 0.4801 to 0.6681 | score on a scale |
| Ankle-brachial Index at Rest at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | Left Side On-Treatment at Rest | 0.5411 | 95% Confidence Interval 0.4479 to 0.6342 | score on a scale |
| Ankle-brachial Index at Rest at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | Left Side Post-Treatment at Rest | 0.5222 | 95% Confidence Interval 0.4254 to 0.6190 | score on a scale |
| Ankle-brachial Index at Rest at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | Right Side Pre-Treatment at Rest | 0.5266 | 95% Confidence Interval 0.3746 to 0.6785 | score on a scale |
| Ankle-brachial Index at Rest at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | Right Side On-Treatment at Rest | 0.5322 | 95% Confidence Interval 0.3827 to 0.6817 | score on a scale |
| Ankle-brachial Index at Rest at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | Right Side Post-Treatment at Rest | 0.5771 | 95% Confidence Interval 0.4122 to 0.7420 | score on a scale |
| Ankle-brachial Index After Exercise at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | Left Side Pre-Treatment after Exercise | 0.5658 | 95% Confidence Interval 0.4651 to 0.6664 | score on a scale |
| Ankle-brachial Index After Exercise at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | Left Side On-Treatment after Exercise | 0.5310 | 95% Confidence Interval 0.4320 to 0.6300 | score on a scale |
| Ankle-brachial Index After Exercise at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | Left Side Post-Treatment after Exercise | 0.5031 | 95% Confidence Interval 0.3989 to 0.6073 | score on a scale |
| Ankle-brachial Index After Exercise at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | Right Side Pre-Treatment after Exercise | 0.6056 | 95% Confidence Interval 0.3927 to 0.8184 | score on a scale |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 7 | |
| Overall Study | COMPLETED | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 7 | |
| Overall Study | NOT COMPLETED | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 0 |
Source ClinicalTrials.gov
Adverse events110
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 |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 2 | 7 | 9 |
| other | Bloating | Gastrointestinal disorders | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 2 | 7 | 2 |
| other | Constipation | Gastrointestinal disorders | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 2 | 7 | 2 |
| other | Dental caries | Gastrointestinal disorders | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 2 | 7 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 7 | 7 | 34 |
| other | Dry mouth | Gastrointestinal disorders | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 1 | 7 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 2 | 7 | 4 |
| other | Dysphagia | Gastrointestinal disorders | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 1 | 7 | 2 |
| other | Esophagitis | Gastrointestinal disorders | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 1 | 7 | 1 |
| other | Gastritis | Gastrointestinal disorders | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 1 | 7 | 1 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 0 | 7 |
| Total, other adverse events | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 7 | 7 |
| Total, serious adverse events | Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC) | 4 | 7 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01585402
GET https://conductscience.org/api/trials/v1/NCT01585402/results?page=2