BridgeMD
Tests treatment safety and results for Hypoparathyroidism
Official title Evaluating the Safety and Efficacy of AMOR-1 as a Treatment for Hypocalcemia Associated With Hypoparathyroidism in Adults
ClinicalTrials.gov ID: NCT06547151
What this study is testing
What is AMOR-1?
AMOR-1 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hypoparathyroidism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Hypoparathyroidism patients, from any etiology, who are on currently available Standard of Care (SoC) e.g., calcium supplement and active vitamin D...
- Oral calcium ≥ 1000 mg QD above the normal dietary calcium intake
You likely can't join if
- Any disease that might affect calcium metabolism or calcium-phosphate homeostasis other than hypoparathyroidism, such as active hyperthyroidism...
- 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. people with asymptomatic renal stones are permitted.
- Poorly controlled short bowel syndrome, bowel resection, tropical sprue, celiac disease, ulcerative colitis, and Crohn's disease.
- Chronic or severe cardiac disease within the past 6 months including but not limited to heart failure classified as NYHA Class II-IV (Dolgin and...
See the full eligibility criteria
- 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...
- Hypoparathyroidism patients, from any etiology, who are on currently available Standard of Care (SoC) e.g., calcium supplement and active vitamin D metabolite/analog.
- Oral calcium ≥ 1000 mg QD above the normal dietary calcium intake
- Albumin-adjusted total serum calcium concentration level between 7.5 mg/dL and 10.5 mg/dL, or if outside of this range, considered not clinically significant by the Investigator.
- Vitamin D metabolite/analog therapy with calcitriol ≥0.25μg QD or alfacalcidol ≥0.50 μg QD.
- Serum 25-hydroxyvitamin D (25OHD) ≥50 nmol/l (20 ng/ml), or if below, considered not clinically significant by the Investigator.
- No change of treatment for hypocalcemia over the last 3 months prior to Screening as reported by the patient or through medical documentation, or if a change has occurred, it is expected to remain stable, as determined...
- Absence or stable symptoms from hypocalcemia over the last 3 months prior to Screening as reported by the patient or through medical documentation.
- For people receiving thyroid replacement therapy, the dose is stable for at least 6 weeks prior to screening and the TSH serum levels are within the normal range. A serum TSH level below the lower limit of the normal...
- Female people who are postmenopausal (12 consecutive months of spontaneous amenorrhea and age \>= 51 years), or who are surgically sterilized may be enrolled, as may women of childbearing potential who had a negative...
- 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...
- 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. people with asymptomatic renal stones are permitted.
- Poorly controlled short bowel syndrome, bowel resection, tropical sprue, celiac disease, ulcerative colitis, and Crohn's disease.
- Chronic or severe cardiac disease within the past 6 months including but not limited to heart failure classified as NYHA Class II-IV (Dolgin and NYHA, 1994), uncontrolled arrhythmias, bradycardia (resting heart rate \...
- History of active or untreated malignancy (excluding thyroid cancer or basal cell skin cancer) within the past 2 years. For thyroid cancers, low-risk well-differentiated thyroid cancer that is stable does not require a...
- Seizure disorder/epilepsy with a history of a seizure within the previous 6 months prior to screening.
- Acute gout within 6 months prior to screening.
- Cerebrovascular accident within 6 months prior to Screening.
- people dependent on regular parenteral calcium infusions (e.g., calcium gluconate) to maintain calcium homeostasis.
- Use of prohibited medications within respective prohibited periods prior to screening such as loop diuretics (30 days), raloxifene hydrochloride (3 months), lithium (30 days), methotrexate at dose \>20 mg per week, or...
- Thiazide diuretics may be permitted if the dosage has remained stable for three months prior to screening, and there is no expected need for a dosage change during the trial.
- Other drugs known to influence calcium and bone metabolism, such as calcitonin, cinacalcet hydrochloride, and fluoride tablets within 3 months prior to screening.
- Use of oral bisphosphonates within 6 months or IV bisphosphonate preparations within 12 months prior to screening.
- Previous treatment with PTH/parathyroid hormone-related protein-like drugs, including PTH(1-84) and PTH(1-34) within 30 days prior to screening.
- Current use of Amorphous Calcium Carbonate (ACC) food supplement.
- History of diagnosed substance abuse or alcohol dependence within the previous 3 years.
- Pregnant/ breastfeeding patients.
The study team makes the final eligibility decision.
Where it's taking place
- Ashdod, Israel, Israel
- Jerusalem, Israel, Israel
- Petah Tikva, Israel, Israel
- Ashkelon, Israel
- Beersheba, Israel
- Haifa, Israel
- Ramat Gan, Israel
- Rehovot, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ashdod, Israel, Israel; Jerusalem, Israel, Israel; Petah Tikva, Israel, Israel; Ashkelon, Israel; Beersheba, Israel; Haifa, Israel and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.