Hypoparathyroidism Clinical Trial
Official title:
A Randomized, Two Phase, Adaptive Then Crossover Open-label, Study Comparing Amorphous Calcium Carbonate (ACC) Supplement Versus Commercially Available Crystalline Calcium Supplements (CCS) in the Management of Primary Hypoparathyroidism.
Primary objective:
Phase I Proof of concept: treatment with smaller doses of elemental calcium from ACC
compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0
mg/dL).
Phase II To test the hypothesis that treatment with smaller doses of elemental calcium from
ACC compared to CCS can maintain target serum calcium (corrected for albumin) values
(7.0-10.0 mg/dL).
Secondary objectives:
Phase I
- ACC dose selection - to confirm the conversion factor of ACC from CCS
- To determine the effect of food on ACC absorption
Phase II
- To test the hypothesis that treatment with smaller doses of elemental calcium from ACC
compared to CCS will not cause an increase in hypercalciuria in patients with
hypoparathyroidism
- To test the hypothesis that smaller doses of elemental calcium from ACC can reduce the
side effects related with high calcium consumption.
Amorphical has a strong basis to believe that the ACC product is better absorbed compared to
the commercially available CCS products and therefore, can maintain desirable target albumin
corrected calcium values in serum (CA) with smaller doses of elemental calcium from ACC. As
results, the burden of taking high doses of calcium supplementation along with the side
effects of the standard therapy (gastrointestinal discomfort and hypercalciuria) will be
reduced.
Testing serum CA and urine calcium values in subjects with hypoparathyroidism may provide a
straightforward method to test this hypothesis.
The study is designed to be conducted with extra precaution in order to avoid disturbing the
fragile balance between CA levels in serum and calcium levels urine. The crossover design of
phase II of the study allows a more accurate and reliable comparison of results attributable
to the specific treatment within the same individual. In addition, the subjects will
continue consuming all their routine medication throughout the trial. The subjects in the
control arm will consume their routine calcium supplement doses thus, will be treated with a
standard of care.
Eligible subjects will be treated as follows:
Phase I Ten (10) subjects previously diagnosed and chronically treated for primary
hypoparathyroidism will be enrolled. The daily CCS intake will be gradually replaced by
reduced amount of elemental calcium from ACC. Five (5) subjects will consume the ACC before
having a meal and the other five (5) subjects will consume the ACC after having a meal. The
safety and the efficacy of the treatment will be closely monitored throughout this phase.
The absorption of ACC will be evaluated using weekly serum calcium corrected for albumin
(CA) value tests. Excretion of calcium in urine will be tested at screening and at the end
of phase I.
I-Day -21 (+/-17) Screening: Subjects with a diagnosed primary hypoparathyroidism (see
section 4.1 for definitions), and who are treated with calcium and vitamin D supplementation
at least 1 year prior to the beginning of the study and are without major renal or hepatic
disease, will be invited to the Clinical Research Center. At the clinic, subjects will be
interviewed, their medical history and their current medication will be documented and they
will sign an informed consent form (ICF). Subjects will be referred to perform blood tests
for serum calcium, P, creatinine and albumin levels. Calculation of albumin corrected
calcium (CA) will be performed. Subjects will be instructed to perform 24 hour urine
collection for Ca, P and creatinine. Subjects will be asked to fill out a food and
medication diary for 3 consecutive days to evaluate their daily dietary calcium intake.
Women of childbearing age will undergo a urine pregnancy test. Eligible subjects, complying
with all inclusion criteria and having none of the exclusion criteria will be enrolled to
the study.
Subjects will be informed by phone or on site whether they are eligible to enter the study.
I-Day 0: Eligible subjects will arrive at the Clinical Research Center where they will be
asked about any changes in their medical condition since their last visit. Blood tests will
be performed to define serum calcium, P and albumin baseline values. Calculation CA at
baseline will be performed.
Subjects will receive a pack of ACC tablets, each tablet containing 50, 100 or 200 mg
elemental calcium (according to the daily total amount of calcium supplementation, 14 day
supply + 5 spare tablets). The replacement of CCS with ACC will be calculated according to
the following formula:
NTDC = ITDC - [0.1×ITDC (mg CCS)] + [0.05×ITDC (mg ACC)]
*ITDC - Initial total daily calcium intake (mg)
**NTDC - New total daily calcium intake (mg)
10% (in mg) out of the initial total daily intake of elemental calcium will be replaced by
5% of elemental calcium from ACC (in mg, calculated out of the initial total daily intake).
The daily intake of vitamin D will remain the same.
The calculation for the number of tablets per day will be performed specifically for each
subject (according to the daily dosage of calcium supplementation) by the doctor.
Subjects will be instructed to take XXX ACC tablets a day, according to their individual
calculated NTDC:
1. Five subjects will be instructed to take XXX tablets in the morning after a meal, XXX
in midday after a meal and XXX in the evening after a meal.
2. Five subjects will be instructed to take XXX tablets in the morning before having a
meal, XXX in midday before having a meal and XXX in the evening before having a meal.
Subjects will be instructed to continue their routine medications consumption during the
trial.
I-Day 3 (±1): Subjects will arrive at the Clinical Research Center and their serum calcium,
P and albumin levels will be tested. Calculation of CA will be performed to exclude
hypocalcaemia (Ca<7.0 mg/dL). If CA values are within the desired target range (7.0-10.0
mg/dl), subjects will continue to take the calcium doses that were instructed on I-day 0. If
CA values are below 7.0 mg/dl or above 10.0 mg/dl, changes to the calcium intake will be
made, according to the doctor's decision.
I-Day 7 (±1): Subjects will arrive at the Clinical Research Center and their serum calcium,
P and albumin levels will be tested. Calculation of CA will be performed:
1. Conversion factor 0.5:
If CA = baseline, then 20% (in mg, calculated out of the initial total daily intake) of
elemental calcium will be replaced by 10% of elemental calcium from ACC (in mg,
calculated out of the initial total daily intake).
NTDC = ITDC - [0.2×ITDC (mg CCS)] + [0.1×ITDC (mg ACC)]
2. Conversion factor 0.75:
If CA < baseline, then 10% (in mg, calculated out of the initial total daily intake) of
elemental calcium will be replaced by 7.5% of elemental calcium from ACC (in mg,
calculated out of the initial total daily intake).
NTDC = ITDC - [0.1×ITDC (mg CCS)] + [0.075×ITDC (mg ACC)] CA <7.00 mg/dl will enforce
end of treatment.
3. Conversion factor 0.25:
If CA > baseline, then 10% (in mg, calculated out of the initial total daily intake) of
elemental calcium will be replaced by 2.5% of elemental calcium from ACC (in mg, calculated
out of the initial total daily intake).
NTDC = ITDC - [0.1×ITDC (mg CCS)] + [0.025×ITDC (mg ACC)] Subjects will be asked about any
side effects or AEs that may have occurred and changes in concomitant medications since
their last visit. Subjects will be asked about symptoms and signs related with a change in
serum calcium levels (tetany, facial grimacing, paresthesias, muscle aches, arrhythmia,
depression). Subjects will receive instructions regarding the new doses of ACC and will be
reminded to take XXX tablets a day (according to their individual calculated NTDC), XXX in
the morning, XXX in midday and XXX in the evening, before or after a meal (based on their
initial assignment). Subjects will be reminded to continue their routine medications
consumption during the trial.
I-Day 10 (±1): Subjects will arrive at the Clinical Research Center and their serum calcium,
P and albumin levels will be tested. Calculation of CA will be performed to exclude
hypocalcaemia (Ca<7.0 mg/dL). If CA levels are within the desired target range (7.0-10.0
mg/dl), subjects will continue to take the calcium doses that were instructed on I-day 7. If
CA levels are below 7.0 mg/dl or above 10.0 mg/dl, changes to the calcium intake will be
made, according to the doctor's decision.
I-Day 14 (±1): Subjects will arrive at the Clinical Research Center and their serum calcium,
P and albumin levels will be tested. Calculation of CA will be performed to exclude
hypocalcaemia (Ca<7.0 mg/dL). If none of the conversion formulas (a-c, I-Day 7) resulted in
serum calcium values within the desired target range (7.0-10.0 mg/dL), the study will be
terminated.
Subjects will be asked about any side effects or AEs that may have occurred and changes in
concomitant medications since their last visit. Subjects will be asked about symptoms and
signs related with a change in serum calcium levels (tetany, facial grimacing, paresthesias,
muscle aches, arrhythmia, depression).
50% of the initial daily supplementation of CCS will be replaced by ACC based on the
conversion factor found in I-day 7 (formulas a-c):
1. Conversion factor 0.5: 50% (in mg, calculated out of the initial total daily intake) of
elemental calcium will be replaced by 25% of elemental calcium from ACC (in mg,
calculated out of the initial total daily intake).
NTDC = ITDC - [0.5×ITDC (mg CCS)] + [0.25×ITDC (mg ACC)]
2. Conversion factor 0.75: 50% (in mg, calculated out of the initial total daily intake)
of elemental calcium will be replaced by 37.5% of elemental calcium from ACC (in mg,
calculated out of the initial total daily intake).
NTDC = ITDC - [0.5×ITDC (mg CCS)] + [0.375×ITDC (mg ACC)]
3. Conversion factor 0.25: 50% (in mg, calculated out of the initial total daily intake)
of elemental calcium will be replaced by 12.5% of elemental calcium from ACC (in mg,
calculated out of the initial total daily intake).
NTDC = ITDC - [0.5×ITDC (mg CCS)] + [0.125×ITDC (mg ACC)] Subjects will receive a pack of
ACC tablets, each tablet containing 50, 100 or 200 mg elemental calcium (according to their
individual calculated NTDC, 14 day supply + 5 spare tablets). Subjects will receive
instructions regarding the new doses of ACC and will be reminded to take XXX capsules a day,
XXX in the morning, XXX in midday and XXX in the evening, before or after a meal (based on
their initial assignment). Subjects will be reminded to continue their routine medications
consumption during the trial.
I-Day 21 (±1): Subjects will arrive at the Clinical Research Center and their serum calcium,
P and albumin levels will be tested. Calculation of CA will be performed to exclude
hypocalcaemia (Ca<7.0 mg/dL). Subjects will be asked about any side effects or AEs that may
have occurred and changes in concomitant medications since their last visit. Subjects will
be asked about symptoms and signs related with a change in serum calcium levels (tetany,
facial grimacing, paresthesias, muscle aches, arrhythmia, depression). If CA levels are
below 7.0 mg/dl, or above 10.0 mg/dl, subject will be excluded from the study (based on the
doctor's decision). If CA levels are within the desired target range (7.0-10.0 mg/dL), a
complete replacement of the daily supplementation of CCS with ACC will be performed, based
on the conversion factor found in I-day 7 (formulas a-c):
1. Conversion factor 0.5: 100% (in mg) of the elemental calcium initial total daily intake
will be replaced by 50% of elemental calcium from ACC (in mg, calculated out of the
initial total daily intake).
NTDC = ITDC - [ITDC (mg CCS)] + [0.5×ITDC (mg ACC)]
2. Conversion factor 0.75: 100% (in mg) of the elemental calcium initial total daily
intake will be replaced by 75% of elemental calcium from ACC (in mg, calculated out of
the initial total daily intake).
NTDC = ITDC - [ITDC (mg CCS)] + [0. 75×ITDC (mg ACC)]
3. Conversion factor 0.25: 100% (in mg) of the elemental calcium initial total daily
intake will be replaced by 25% of elemental calcium from ACC (in mg, calculated out of
the initial total daily intake).
NTDC = ITDC - [ITDC (mg CCS)] + [0.25×ITDC (mg ACC)] Subjects will receive instructions
regarding the new doses of ACC and will be reminded to take XXX tablets a day, XXX in the
morning, XXX in midday and XXX in the evening, before or after a meal (based on their
initial assignment). Subjects will be reminded to continue their routine medications
consumption during the trial.
Subjects will receive a container to perform 24 hour urine collection prior to their next
scheduled visit.
I-Day 27 (±1) by phone: Subjects will be reminded to perform 24 hour urine collection.
I-Day 28 (±1) - Termination of phase I: Subjects will arrive at the Clinical Research Center
and their serum calcium, P and albumin levels will be tested. Calculation of CA will be
performed. Subjects will provide the container of 24 hour urine collection for Ca, P and
creatinine to test calciuria. Subjects will be asked about any side effects or AEs that may
have occurred and changes in concomitant medications since their last visit. Subjects will
be asked about symptoms and signs related with a change in serum calcium levels (tetany,
facial grimacing, paresthesias, muscle aches, arrhythmia, depression).
Phase I results will be examined before deciding whether or not to embark on the crossover
portion of the study planned for Phase II. Phase I data will be summarized, showing for each
subject, by arm and overall the relationship between CA levels by amount of ACC replacement
of CCS received.
Phase II Ten (10) subjects previously diagnosed and chronically treated for primary
hypoparathyroidism will be enrolled. Subjects participated in phase I will be offered to
participate in phase II as well. If needed, new subjects will be enrolled.
The subjects will be randomly assigned to one of the following treatments for 6 weeks:
1. Standard of care (CCS) - The same elemental calcium dosage that was used routinely
prior to the study.
2. ACC - The established dosage of elemental calcium from ACC (based on the conversion
factor and the fed/fasted conditions found in phase I of the study).
The two formulations will be administered with the regular daily dosage of vitamin D (1-alfa
D3).
At the end of the treatment, each group will receive the alternative formulation for another
6 weeks.
The superior absorption of ACC will be evaluated using weekly blood tests to calculate serum
CA values. Excretion of calcium in urine will be tested at screening and in the end of each
treatment.
II-Day -21 (+/-17) Screening: Subjects with a diagnosed primary hypoparathyroidism (see
section 4.1 for definitions), and who receiving calcium and vitamin D supplementation at
least 1 year prior to the beginning of the study and are without major renal or hepatic
disease, will be invited to the Clinical Research Center . At the clinic, subjects will be
interviewed, their medical history and their current medication will be documented and they
will sign an informed consent form (ICF). Subjects will be referred to perform blood tests
for Calcium, P and albumin levels. Calculation of CA will be performed. Subjects will be
instructed to perform 24 hour urine collection for Ca, P and creatinine levels. Subjects
will be asked to fill out a food and medication diary for 3 consecutive days to evaluate
their daily dietary calcium intake. Women of childbearing age will undergo a urine pregnancy
test. Eligible subjects, complying with all inclusion criteria and having none of the
exclusion criteria will be enrolled to the study.
Subjects will be informed by phone or on site whether they are eligible to enter the study.
II-Day 0: Eligible subjects will arrive at the Clinical Research Center where they will be
asked about any changes in their medical condition since their last visit. Blood tests will
be performed to define serum calcium, P and albumin baseline values. CA values will be
calculated at baseline.
Subjects will be randomly assigned to one of the following treatments:
1. Standard-of-care (CCS) - The same elemental calcium dosage that was used routinely
prior to the study.
2. ACC - The established dosage of elemental calcium from ACC (based on the conversion
factor and the fed/fasted conditions found in phase I of the study).
Subjects that were assigned to the ACC treatment arm, will receive a pack of ACC tablets,
each tablet containing 200 mg elemental calcium (35 day supply + 5 spare tablets). Subjects
assigned to the CCS treatment arm will continue to take their routine calcium
supplementation.
The exact dosage of calcium supplementation will be determined for each subject according
the known medical history.
Subjects will be instructed to continue their routine medications consumption during the
trial.
II-Day 3 (±1): Subjects will arrive at the Clinical Research Center and their serum calcium,
P and albumin levels will be tested. Calculation of CA will be performed to exclude
hypocalcaemia (Ca<7.0 mg/dL). If CA values are within the desired target range (7.0-10.0
mg/dl), subjects will continue to take the calcium doses that were instructed on II-day 0.
If CA levels are below 7.0 mg/dL or above 10.0 mg/dL, changes to calcium intake will be
made, according to the doctor's decision
II-Day 7 (±1): Subjects will arrive at the Clinical Research Center and their serum calcium,
P and albumin levels will be tested. Calculation of CA will be performed. Subjects will be
asked about any side effects or AEs that may have occurred and changes in concomitant
medications since their last visit. Subjects will be asked about symptoms and signs related
with a change in serum calcium levels (tetany, facial grimacing, paresthesias, muscle aches,
arrhythmia, depression). Adjustments of ACC or CCS intake will be performed if necessary.
Subjects will be reminded to take the calcium supplementation according to their assignment
instructions.
Subjects will be reminded to continue their routine medications consumption during the
trial.
II-Day 10 (±1): Subjects will arrive at the Clinical Research Center and their serum
calcium, P and albumin levels will be tested. Calculation of CA will be performed to exclude
hypocalcaemia (Ca<7.0 mg/dL). If CA levels are within the desired target range (7.0-10.0
mg/dl), subjects will continue to take the calcium doses that were instructed on II-day 7.
If CA levels are below 7.0 mg/dL, or above 10.0 mg/dL, changes to the calcium intake will be
made, according to the doctor's decision
II-Day 14 (±1): Subjects will arrive at the Clinical Research Center and their serum
calcium, P and albumin levels will be tested. Calculation of CA will be performed. Subjects
will be asked about any side effects or AEs that may have occurred and changes in
concomitant medications since their last visit. Subjects will be asked about symptoms and
signs related with a change in serum calcium levels (tetany, facial grimacing, paresthesias,
muscle aches, arrhythmia, depression).
Subjects will be reminded to take the calcium supplementation according to their assignment
instructions.
Subjects will be reminded to continue their routine medications consumption during the
trial.
II-Day 21 (±1): Subjects will arrive at the Clinical Research Center and their serum
calcium, P and albumin will be tested. Calculation of CA will be performed. Subjects will be
asked about any side effects or AEs that may have occurred and changes in concomitant
medications since their last visit. Subjects will be asked about symptoms and signs related
with a change in serum calcium levels (tetany, facial grimacing, paresthesias, muscle aches,
arrhythmia, depression).
Subjects will be reminded to take the calcium supplementation according to the instructions.
Subjects will be reminded to continue their routine medications consumption during the
trial.
Subjects will receive a container to perform 24 hour urine collection prior to their next
scheduled visit.
II-Day 34 (±1) by phone: Subjects will be reminded to perform 24 hour urine collection.
II-Day 35 (±1): Subjects will arrive to the Clinical Research Center and their serum
calcium, P and albumin levels will be tested. Calculation of CA will be performed. Subjects
will provide the container with 24 hour urine collection for Ca, P and creatinine to test
calciuria. Subjects will be asked about any side effects or AEs that may have occurred and
changes in concomitant medications since their last visit. Subjects will be asked about
symptoms and signs related with a change in serum calcium levels (tetany, facial grimacing,
paresthesias, muscle aches, arrhythmia, depression).
Subjects previously assigned to the CCS treatment arm will receive a pack of ACC tablets,
each tablet containing 200 mg elemental calcium (35 day supply + 5 spare tablets). Subjects
previously assigned to the ACC treatment arm, will be instructed to resume their regular CCS
supplementation.
The exact dosage of calcium supplementation for each subject will be determined by the known
medical history.
Subjects will be reminded to continue their routine medications consumption during the
trial.
II-Day 38 (±1): Subjects will arrive at the Clinical Research Center and their serum
calcium, P and albumin levels will be tested. Calculation of CA will be performed to exclude
hypocalcaemia (Ca<7.0 mg/dL). If CA levels are within the desired target range (7.0-10.0
mg/dl), subjects will continue to take the calcium doses that were instructed on II-day 35.
If CA levels are below 7.0 mg/dl or above 10.0 mg/dl, changes to the calcium intake will be
made, according to the doctor's decision
II-Day 42 (±1): Subjects will arrive at the Clinical Research Center and their serum
calcium, P and albumin levels will be tested. Calculation of CA will be performed. Subjects
will be asked about any side effects or AEs that may have occurred and changes in
concomitant medications since their last visit. Subjects will be asked about symptoms and
signs related with a change in serum calcium levels (tetany, facial grimacing, paresthesias,
muscle aches, arrhythmia, depression). Adjustments of ACC or CCS intake will be performed if
necessary.
Subjects will be reminded to take the calcium supplementation according to their assignment
instructions.
Subjects will be reminded to continue their routine medications consumption during the
trial.
II-Day 45 (±1): Subjects will arrive at the Clinical Research Center and their serum
calcium, P and albumin levels will be tested. Calculation of CA will be performed to exclude
hypocalcaemia (Ca<7.0 mg/dL). If CA levels are within the desired target range (7.0-10.0
mg/dl), subjects will continue to take the calcium doses that were instructed on II-day 42.
If CA levels are below 7.0 mg/dl or above 10.0 mg/dl, changes to the calcium intake will be
made, according to the doctor's decision
II-Day 49 (±1): Subjects will arrive at the Clinical Research Center and their serum
calcium, P and albumin levels will be tested. Calculation of CA will be performed. Subjects
will be asked about any side effects or AEs that may have occurred and changes in
concomitant medications since their last visit. Subjects will be asked about symptoms and
signs related with a change in serum calcium levels (tetany, facial grimacing, paresthesias,
muscle aches, arrhythmia, depression).
Subjects will be reminded to take the calcium supplementation according to their assignment
instructions.
Subjects will be reminded to continue their routine medications consumption during the
trial.
II-Day 56 (±1): Subjects will arrive at the Clinical Research Center and their serum
calcium, P and albumin levels will be tested. Calculation of CA will be performed. Subjects
will be asked about any side effects or AEs that may have occurred and changes in
concomitant medications since their last visit. Subjects will be asked about symptoms and
signs related with a change in serum calcium levels (tetany, facial grimacing, paresthesias,
muscle aches, arrhythmia, depression).
Subjects will be reminded to take the calcium supplementation according to their assignment
instructions.
Subjects will be reminded to continue their routine medications consumption during the
trial.
Subjects will receive a container to perform 24 hour urine collection prior to their next
scheduled visit.
II-Day 69 (±1) by phone: Subjects will be reminded to perform 24 hour urine collection.
II-Day 70 (±1) - Termination of phase II: Subjects will arrive at the Clinical Research
Center and their serum calcium, P and albumin levels will be tested. Calculation of CA will
be performed. Subjects will provide the container with 24 hour urine collection for Ca, P
and creatinine to test calciuria. Subjects will be asked about any side effects or AEs that
may have occurred and changes in concomitant medications since their last visit. Subjects
will be asked about symptoms and signs related with a change in serum calcium levels
(tetany, facial grimacing, paresthesias, muscle aches, arrhythmia, depression).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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