Trial Outcomes & Findings for Etidronate for Arterial Calcifications Due to Deficiency in CD73 (ACDC) (NCT NCT01585402)
NCT ID: NCT01585402
Last Updated: 2022-10-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment)
Results posted on
2022-10-04
Participant Flow
Participants were recruited at the National Institutes of Health Clinical Care Center at Bethesda, Maryland from August 2012 to August 2021.
Participant milestones
| Measure |
Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
Participants diagnosed with Arterial Calcifications due to Deficiency in CD73 (ACDC) will receive Etidronate. Etidronate will be administered orally at total dose of 20mg/kg daily x 14 days, followed by 10 weeks off study drug (12 weeks = one cycle). Participants may receive up to 12 cycles of etidronate.
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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Etidronate for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
Baseline characteristics by cohort
| Measure |
Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
n=7 Participants
Participants diagnosed with Arterial Calcifications due to Deficiency in CD73 (ACDC) will receive Etidronate. Etidronate will be administered orally at total dose of 20mg/kg daily x 14 days, followed by 10 weeks off study drug (12 weeks = one cycle). Participants may receive up to 12 cycles of etidronate.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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7 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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7 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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6 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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7 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment)Population: 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.
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.
Outcome measures
| Measure |
Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
n=7 Participants
Participants diagnosed with Arterial Calcifications due to Deficiency in CD73 (ACDC) will receive Etidronate. Etidronate will be administered orally at total dose of 20mg/kg daily x 14 days, followed by 10 weeks off study drug (12 weeks = one cycle). Participants may receive up to 12 cycles of etidronate.
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Ankle-brachial Index at Rest at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Left Side Pre-Treatment at Rest
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0.5741 score on a scale
Interval 0.4801 to 0.6681
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Ankle-brachial Index at Rest at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Left Side On-Treatment at Rest
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0.5411 score on a scale
Interval 0.4479 to 0.6342
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Ankle-brachial Index at Rest at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Left Side Post-Treatment at Rest
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0.5222 score on a scale
Interval 0.4254 to 0.619
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Ankle-brachial Index at Rest at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Right Side Pre-Treatment at Rest
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0.5266 score on a scale
Interval 0.3746 to 0.6785
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Ankle-brachial Index at Rest at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Right Side On-Treatment at Rest
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0.5322 score on a scale
Interval 0.3827 to 0.6817
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Ankle-brachial Index at Rest at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Right Side Post-Treatment at Rest
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0.5771 score on a scale
Interval 0.4122 to 0.742
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PRIMARY outcome
Timeframe: Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment)Population: 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.
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.
Outcome measures
| Measure |
Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
n=7 Participants
Participants diagnosed with Arterial Calcifications due to Deficiency in CD73 (ACDC) will receive Etidronate. Etidronate will be administered orally at total dose of 20mg/kg daily x 14 days, followed by 10 weeks off study drug (12 weeks = one cycle). Participants may receive up to 12 cycles of etidronate.
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Ankle-brachial Index After Exercise at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Left Side On-Treatment after Exercise
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0.5310 score on a scale
Interval 0.432 to 0.63
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Ankle-brachial Index After Exercise at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Left Side Pre-Treatment after Exercise
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0.5658 score on a scale
Interval 0.4651 to 0.6664
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Ankle-brachial Index After Exercise at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Left Side Post-Treatment after Exercise
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0.5031 score on a scale
Interval 0.3989 to 0.6073
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Ankle-brachial Index After Exercise at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Right Side Pre-Treatment after Exercise
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0.6056 score on a scale
Interval 0.3927 to 0.8184
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Ankle-brachial Index After Exercise at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Right Side On-Treatment after Exercise
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0.5664 score on a scale
Interval 0.3483 to 0.7844
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Ankle-brachial Index After Exercise at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Right Side Post-Treatment after Exercise
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0.4077 score on a scale
Interval 0.1878 to 0.6275
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PRIMARY outcome
Timeframe: Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment)Population: 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.
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.
Outcome measures
| Measure |
Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
n=7 Participants
Participants diagnosed with Arterial Calcifications due to Deficiency in CD73 (ACDC) will receive Etidronate. Etidronate will be administered orally at total dose of 20mg/kg daily x 14 days, followed by 10 weeks off study drug (12 weeks = one cycle). Participants may receive up to 12 cycles of etidronate.
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Computed Tomography Calcium Score of Lower Extremities at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Left Lower Extremity Pre-Treatment
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88817 score on a scale
Interval 20615.0 to 157019.0
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Computed Tomography Calcium Score of Lower Extremities at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Left Lower Extremity On-Treatment
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91454 score on a scale
Interval 23243.0 to 159664.0
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Computed Tomography Calcium Score of Lower Extremities at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Left Lower Extremity Post-Treatment
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94358 score on a scale
Interval 26166.0 to 162551.0
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Computed Tomography Calcium Score of Lower Extremities at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Right Lower Extremity Pre-Treatment
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80289 score on a scale
Interval 12355.0 to 148222.0
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Computed Tomography Calcium Score of Lower Extremities at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Right Lower Extremity On-Treatment
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81641 score on a scale
Interval 13689.0 to 149592.0
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Computed Tomography Calcium Score of Lower Extremities at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Right Lower Extremity Post-Treatment
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83950 score on a scale
Interval 16206.0 to 151694.0
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SECONDARY outcome
Timeframe: Up to 2 years (pre-treatment), 3 years (on-treatment)Population: One participant received 11 drug cycles (not 12 cycles) due to discontinuation of the drug by the manufacturer.
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).
Outcome measures
| Measure |
Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
n=7 Participants
Participants diagnosed with Arterial Calcifications due to Deficiency in CD73 (ACDC) will receive Etidronate. Etidronate will be administered orally at total dose of 20mg/kg daily x 14 days, followed by 10 weeks off study drug (12 weeks = one cycle). Participants may receive up to 12 cycles of etidronate.
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Changes in Hand Joint Calcification Based on Hand X-ray Before and During Etidronate in Participants Diagnosed With ACDC
Left Hand Pre-Treatment
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241.16 score on a scale
Interval 148.45 to 333.87
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Changes in Hand Joint Calcification Based on Hand X-ray Before and During Etidronate in Participants Diagnosed With ACDC
Left Hand On Treatment
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275.15 score on a scale
Interval 173.43 to 376.88
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Changes in Hand Joint Calcification Based on Hand X-ray Before and During Etidronate in Participants Diagnosed With ACDC
Right Hand Pre Treatment
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255.77 score on a scale
Interval 119.4 to 392.13
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Changes in Hand Joint Calcification Based on Hand X-ray Before and During Etidronate in Participants Diagnosed With ACDC
Right Hand On Treatment
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360.20 score on a scale
Interval 209.41 to 510.98
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SECONDARY outcome
Timeframe: Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment)Population: One participant received 11 drug cycles due to discontinuation of the drug by the manufacturer.
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.
Outcome measures
| Measure |
Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
n=7 Participants
Participants diagnosed with Arterial Calcifications due to Deficiency in CD73 (ACDC) will receive Etidronate. Etidronate will be administered orally at total dose of 20mg/kg daily x 14 days, followed by 10 weeks off study drug (12 weeks = one cycle). Participants may receive up to 12 cycles of etidronate.
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Simple Disease Activity Index Score at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Pre-Treatment
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18.5919 score on a scale
Interval 14.5739 to 22.6099
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Simple Disease Activity Index Score at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
On-treatment
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8.2987 score on a scale
Interval 5.1215 to 11.4759
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Simple Disease Activity Index Score at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Post-treatment
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5.0098 score on a scale
Interval 1.1502 to 8.8693
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SECONDARY outcome
Timeframe: Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment)Population: One participant received 11 drug cycles (not 12 cycles) due to discontinuation of the drug by the manufacturer.
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.
Outcome measures
| Measure |
Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
n=7 Participants
Participants diagnosed with Arterial Calcifications due to Deficiency in CD73 (ACDC) will receive Etidronate. Etidronate will be administered orally at total dose of 20mg/kg daily x 14 days, followed by 10 weeks off study drug (12 weeks = one cycle). Participants may receive up to 12 cycles of etidronate.
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Duke Activity Status Index Score at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Pre-Treatment
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47.2282 score on a scale
Interval 41.0117 to 53.4447
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Duke Activity Status Index Score at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
On-treatment
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46.6314 score on a scale
Interval 41.8702 to 51.3926
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Duke Activity Status Index Score at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC
Post-treatment
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50.8242 score on a scale
Interval 44.6566 to 56.9917
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SECONDARY outcome
Timeframe: Up to 2 years (pre-treatment), 3 years (on-treatment) and up to 1 year (post-treatment)Population: One participant received 11 drug cycles (not 12 cycles) due to discontinuation of the drug by the manufacturer.
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.
Outcome measures
| Measure |
Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
n=7 Participants
Participants diagnosed with Arterial Calcifications due to Deficiency in CD73 (ACDC) will receive Etidronate. Etidronate will be administered orally at total dose of 20mg/kg daily x 14 days, followed by 10 weeks off study drug (12 weeks = one cycle). Participants may receive up to 12 cycles of etidronate.
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Peak Metabolic Equivalents (METS) During Treadmill Test at Pre-treatment, On-treatment and Post- Treatment of Etidronate in Participants Diagnosed With ACDC
Left Lower Extremity Pre-Treatment
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6.2514 Metabolic Equivalents
Interval 5.4057 to 7.0971
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Peak Metabolic Equivalents (METS) During Treadmill Test at Pre-treatment, On-treatment and Post- Treatment of Etidronate in Participants Diagnosed With ACDC
Left Lower Extremity On-Treatment
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6.2577 Metabolic Equivalents
Interval 5.4467 to 7.0687
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Peak Metabolic Equivalents (METS) During Treadmill Test at Pre-treatment, On-treatment and Post- Treatment of Etidronate in Participants Diagnosed With ACDC
Left Lower Extremity Post-Treatment
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6.2888 Metabolic Equivalents
Interval 5.406 to 7.1717
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Peak Metabolic Equivalents (METS) During Treadmill Test at Pre-treatment, On-treatment and Post- Treatment of Etidronate in Participants Diagnosed With ACDC
Right Lower Extremity Pre-Treatment
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6.2514 Metabolic Equivalents
Interval 5.4057 to 7.0971
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Peak Metabolic Equivalents (METS) During Treadmill Test at Pre-treatment, On-treatment and Post- Treatment of Etidronate in Participants Diagnosed With ACDC
Right Lower Extremity On-Treatment
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6.2577 Metabolic Equivalents
Interval 5.4467 to 7.0687
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Peak Metabolic Equivalents (METS) During Treadmill Test at Pre-treatment, On-treatment and Post- Treatment of Etidronate in Participants Diagnosed With ACDC
Right Lower Extremity Post-Treatment
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6.2888 Metabolic Equivalents
Interval 5.406 to 7.1717
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Adverse Events
Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
n=7 participants at risk
Participants diagnosed with Arterial Calcifications due to Deficiency in CD73 (ACDC) will receive Etidronate. Etidronate will be administered orally at total dose of 20mg/kg daily x 14 days, followed by 10 weeks off study drug (12 weeks = one cycle). Participants may receive up to 12 cycles of etidronate.
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Nervous system disorders
Stroke
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14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
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Gastrointestinal disorders
Abdominal pain
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14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
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Gastrointestinal disorders
Constipation
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14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
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Gastrointestinal disorders
Lower gastrointestinal hemorrhage
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14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
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Infections and infestations
Lung infection
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14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
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Infections and infestations
Skin infection
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28.6%
2/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
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Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
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Vascular disorders
External iliac artery stenosis
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
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|
Vascular disorders
Jump graft on the bypass area declining function of previous graft
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
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Other adverse events
| Measure |
Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
n=7 participants at risk
Participants diagnosed with Arterial Calcifications due to Deficiency in CD73 (ACDC) will receive Etidronate. Etidronate will be administered orally at total dose of 20mg/kg daily x 14 days, followed by 10 weeks off study drug (12 weeks = one cycle). Participants may receive up to 12 cycles of etidronate.
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|---|---|
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Gastrointestinal disorders
Abdominal pain
|
28.6%
2/7 • Number of events 9 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Gastrointestinal disorders
Bloating
|
28.6%
2/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
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|
Gastrointestinal disorders
Dental caries
|
28.6%
2/7 • Number of events 3 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
7/7 • Number of events 34 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Gastrointestinal disorders
Dyspepsia
|
28.6%
2/7 • Number of events 4 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Gastrointestinal disorders
Esophagitis
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Gastrointestinal disorders
Gastritis
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
28.6%
2/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Gastrointestinal disorders
Nausea
|
71.4%
5/7 • Number of events 21 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Gastrointestinal disorders
Periodontal disease
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Gastrointestinal disorders
Toothache
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Gastrointestinal disorders
Vomiting
|
57.1%
4/7 • Number of events 9 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
2/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Metabolism and nutrition disorders
Cholesterol high
|
28.6%
2/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
57.1%
4/7 • Number of events 4 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
42.9%
3/7 • Number of events 3 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Cardiac disorders
Premature atrial contractions
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Cardiac disorders
Left atrial enlargement; Incomplete right bundle branch block
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Cardiac disorders
Chest pain - cardiac
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Cardiac disorders
Palpitations
|
42.9%
3/7 • Number of events 4 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Cardiac disorders
Sinus bradycardia
|
42.9%
3/7 • Number of events 3 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Psychiatric disorders
Anxiety
|
28.6%
2/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Psychiatric disorders
Vivid dreams
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
14.3%
1/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Immune system disorders
Allergic reaction
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
2/7 • Number of events 3 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Investigations
Cholesterol high
|
28.6%
2/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Investigations
Creatinine increased
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Investigations
Lymphocyte count decreased
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Investigations
Weight gain
|
28.6%
2/7 • Number of events 3 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Investigations
Weight loss
|
28.6%
2/7 • Number of events 3 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Investigations
White blood cell decreased
|
14.3%
1/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
71.4%
5/7 • Number of events 9 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
42.9%
3/7 • Number of events 3 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
28.6%
2/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Musculoskeletal and connective tissue disorders
Calcaneus spur
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Musculoskeletal and connective tissue disorders
Joint inflammation/pain
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
71.4%
5/7 • Number of events 5 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Reproductive system and breast disorders
Pelvic pain
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Ear and labyrinth disorders
Ear pain
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Infections and infestations
Cold symptoms
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Infections and infestations
Streptococcus pyogenes
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Infections and infestations
Strep agalactiae Urinary tract infection
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Infections and infestations
Laryngitis
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Infections and infestations
Skin infection
|
28.6%
2/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Infections and infestations
Upper respiratory infection
|
28.6%
2/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
General disorders
Malaise
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
28.6%
2/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Nervous system disorders
Dizziness
|
42.9%
3/7 • Number of events 5 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Nervous system disorders
Dysgeusia
|
42.9%
3/7 • Number of events 7 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Nervous system disorders
Headache
|
42.9%
3/7 • Number of events 9 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Nervous system disorders
Memory impairment
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Nervous system disorders
Paresthesia
|
28.6%
2/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Nervous system disorders
Presyncope
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Nervous system disorders
Somnolence
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Nervous system disorders
Syncope
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Renal and urinary disorders
Hematuria
|
28.6%
2/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Renal and urinary disorders
Hemoglobinuria
|
14.3%
1/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Renal and urinary disorders
Elevated urine phosphorus
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Renal and urinary disorders
Renal calculi
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Renal and urinary disorders
Urinary frequency
|
14.3%
1/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
General disorders
Edema limbs
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
General disorders
Fatigue
|
71.4%
5/7 • Number of events 9 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
General disorders
Left inguinal hernia surgery
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
General disorders
Arthralgia flare swelling of right hand
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
General disorders
Arthralgia flare swelling of right wrist
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
General disorders
Swelling of finger on fourth MCP of right hand
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
General disorders
Hemorrhoids
|
14.3%
1/7 • Number of events 2 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
General disorders
Injection site reaction
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
General disorders
Non-cardiac chest pain
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Blood and lymphatic system disorders
Anemia
|
42.9%
3/7 • Number of events 4 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Injury, poisoning and procedural complications
Fracture
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
28.6%
2/7 • Number of events 3 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Skin and subcutaneous tissue disorders
Blister on right 4th toe
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
14.3%
1/7 • Number of events 3 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Endocrine disorders
Hyperparathyroidism
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
General disorders
Flu like symptoms
|
42.9%
3/7 • Number of events 5 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Vascular disorders
Hypertension
|
28.6%
2/7 • Number of events 5 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Eye disorders
Blurred vision
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
|
Eye disorders
Dry eye
|
14.3%
1/7 • Number of events 1 • 37 months
Adverse events will be captured from the start of the first etidronate administration (day 0) until 30 days following the last dose of treatment. Following this period, any observed or volunteered adverse events will NOT be reported or recorded unless they are greater than Grade 1 and deemed possibly, probably or definitely related to a procedure, test or screening examination that was administered as part of this protocol.
|
Additional Information
Alessandra Brofferio, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301.496.2634
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place