This clinical trial aims to evaluate the efficacy and safety of AMOR-1, consisting of Amorphous Calcium Carbonate (ACC) as the active drug substance, in treating hypocalcemia in adults with hypoparathyroidism.
An understanding, ability, and willingness to fully comply with study procedures and restrictions.
Ability to voluntarily provide written, signed, and dated informed consent as applicable to participants in the study.
Adult males or females 18 or older (prior to screening). Those < 25 years old will be examined radiologically (Bone age X-ray of non-dominant wrist and hand) to ensure epiphyseal closure prior to enrollment into the study.
Hypoparathyroidism patients, from any etiology, who are on currently available Standard of Care (SoC) e.g., calcium supplement and active vitamin D metabolite/analog.
Any disease that might affect calcium metabolism or calcium-phosphate homeostasis other than hypoparathyroidism, such as active hyperthyroidism, Paget's disease of bone, Type 1 or poorly controlled Type 2 diabetes mellitus (HbA1c > 9%), acromegaly, multiple endocrine neoplasia types I and II, Cushing's syndrome or disease, acute pancreatitis, malnutrition, recent prolonged immobility.
Severe liver disease (Child-Pugh score >9) (US FDA, 2003) or hepatic transaminases (ALT and AST) > 3 times the upper limit.
Severe renal insufficiency defined as estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2.
Clinical history of symptomatic renal stones within the past 3 months. Subjects with asymptomatic renal stones are permitted.
Parallel
AMOR-1
DrugInvestigational arm: Tablets containing 250mg elemental calcium from Amorphous Calcium Carbonate (ACC).
Crystalline Calcium Carbonate
DrugControl arm: Crystalline Calcium Carbonate (CCC) oral tablet contains 500 mg elemental calcium.
Percentage of Subjects Who Achieved the Primary Composite Endpoint at Week 14
The composite efficacy endpoint is defined as: Subject had a reduction from baseline in total daily dose of oral calcium supplementation of at least 50%, and an albumin-adjusted total serum calcium concentration level between 8.0 mg/dL (incl.) and 10.0 mg/dL (incl.), and no increase from baseline in vitamin D metabolite/analog
Albumin-adjusted serum calcium
Proportion of participants who achieved albumin-adjusted serum calcium concentrations above, below, or in the range of 8.0 mg/dl and 10.0 mg/dl during Dose Maintenance.
Urinary Calcium Excretion
Change From Baseline in Urinary Calcium Excretion
Urine calcium excretion above 300mg/24h
Incidence of increase in urine calcium excretion (\>300 mg/24h) during Dose Maintenance
GI symptoms
Incidence of GI symptoms associated with calcium intake
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