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.
AMOR-1 contains Amorphous Calcium Carbonate (ACC) nanoparticles, which provide higher calcium absorption and bioavailability compared to the crystalline form. Therefore, significantly smaller doses of elemental calcium provided by ACC may be sufficient to maintain the desired serum calcium levels in people with hypoparathyroidism. The lower calcium doses can potentially reduce the adverse effects, associated with long-term, high daily doses of calcium supplementation, consumed by these patients. The main question for the study is: Can replacing the current calcium supplement with AMOR-1, which contains half the amount of elemental calcium, maintain blood calcium levels in people with hypoparathyroidism? Patients with a history of hypoparathyroidism will be randomized in a 2:1 ratio to receive either AMOR-1 or Control (the conventional crystalline calcium carbonate supplement), respectively. Their current dose of calcium supplement will be gradually replaced with AMOR-1 or the Control over 2-4 weeks. At the end of the replacement phase, participants in the AMOR-1 arm are anticipated to receive 50% of the elemental calcium compared to their initial intake from the crystalline calcium supplements. Subjects in the Control arm will maintain their initial elemental calcium intake. Following this replacement phase, the participants will continue receiving their individual dose of AMOR-1 or the Control for an additional 10-12 weeks (Dose Maintenance phase). At the end of this phase, the participants will revert to their initial calcium supplement and will be monitored for an additional month until the end of the study. All participants will receive an active form of vitamin D in parallel to the study treatment. Throughout the study, participants will be routinely monitored for safety and efficacy, including calcium levels in the blood and urine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Investigational arm: Tablets containing 250mg elemental calcium from Amorphous Calcium Carbonate (ACC).
Control arm: Crystalline Calcium Carbonate (CCC) oral tablet contains 500 mg elemental calcium.
Assuta Ashdod medical center
Ashdod, Israel, Israel
Lin Medical Center
Haifa, Israel, Israel
Hadassah Ein Kerem Medical Center
Jerusalem, Israel, Israel
Rabin Medical Center, Belinson Campus
Petah Tikva, Israel, Israel
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
Time frame: 14 weeks
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.
Time frame: Week 4 to Week 14
Urinary Calcium Excretion
Change From Baseline in Urinary Calcium Excretion
Time frame: Week 14
Urine calcium excretion above 300mg/24h
Incidence of increase in urine calcium excretion (\>300 mg/24h) during Dose Maintenance
Time frame: Week 4 to Week 14
GI symptoms
Incidence of GI symptoms associated with calcium intake
Time frame: Week 4 to Week 14
Symptoms associated with hypocalcemia
Incidence of symptoms associated with hypocalcemia
Time frame: Week 4 to Week 14
Hypoparathyroidism Patient Experience Scale (HPES)- Experience (HPES) - Symptom
Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) - Symptom total score at Week 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Barzilai Medical Center
Ashkelon, Israel
Soroka Medical Center
Beersheba, Israel
Rambam Medical Center
Haifa, Israel
Sheba Medical Center
Ramat Gan, Israel
Kaplan Medical Center
Rehovot, Israel
Time frame: Week 14
HPES - Impact
Change from baseline in HPES - Impact total score at Week 14
Time frame: Week 14
HPES - Symptom - Physical Domain
Change from baseline HPES - Symptom - Physical Domain score at Week 14
Time frame: Week 14
HPES - Symptom - Cognitive Domain
Change from baseline in HPES - Symptom - Cognitive Domain score at Week 14
Time frame: Week 14
HPES - Impact - Physical Functioning Domain
Change from baseline in HPES - Impact - Physical Functioning Domain score at Week 14
Time frame: eek 14
HPES - Impact - Daily Life Domain
Change from baseline in HPES - Impact - Daily Life Domain score at Week 14
Time frame: Week 14
HPES - Impact - Psychological Well-Being Domain
Change from baseline in HPES - Impact - Psychological Well-Being Domain score at Week 14
Time frame: Week 14
HPES - Impact - Social Life and Relationships Domain
Change from baseline in HPES - Impact - Social Life and Relationships Domain score at Week 14
Time frame: Week 14
36-item Short Form (SF-36) survey
Change From baseline in health-related quality-of-life measured with 36-item Short Form (SF-36) survey at Week 14
Time frame: Week 14