Parathyroid Disorder

Researchers are evaluating whether 18F-choline positron-emission-tomography computed tomography 18F-ch-PET-CT is better than conventional imaging methods like ultrasonography and sestamibi scintigraphy at locating diseased parathyroid glands in adults with primary hyperparathyroidism pHPT. The study aims to improve surgical precision, increase cure rates, reduce complications, and shorten operation times. Primary hyperparathyroidism causes problems like kidney stones and bone weakness because of enlarged parathyroid glands producing too much hormone. This open, randomized clinical trial compares two imaging approaches before surgery. One group receives 18F-ch-PET-CT imaging, while the other undergoes standard ultrasonography and sestamibi scintigraphy. Patients are randomly assigned to one of these groups. The study will measure how long the surgery takes and look at cure rates, complication rates, and the accuracy of each imaging method. The trial is conducted at a single center and does not involve blinding. Participants will have their imaging results and surgery details recorded. Researchers will monitor operation times from start to finish and evaluate cure by checking calcium levels one month after surgery. They will also track complications like nerve damage or persistent disease. Data are collected securely in a national registry. The study aims to include 100 participants and expects to complete analyses within a few years. Safety monitoring includes assessment of potential side effects from the imaging agents used.

Researchers are evaluating the use of a PET isotope called Fluorine-18 18F attached to Choline in people suspected of having parathyroid adenoma who have negative or unclear results from the standard 99mTc Sestamibi SPECTCT scan. The study focuses on detecting parathyroid adenomas using this new imaging technique in a single-center, single-arm trial. Participants receive an intravenous injection of 18F Fluorocholine about 5 mCi with a 20% margin, followed 45 to 60 minutes later by a low dose CT scan from the skull base to mid-thighs. This is immediately followed by a static PET emission scan over the same area, aiming to locate parathyroid adenomas more effectively than the standard scan. During the study, participants undergo the PETCT imaging process once, and researchers measure the number of lesions detected within an hour after the scan. Safety is monitored through blood tests and heart monitoring prior to the scan. The total participation time is brief and focused on imaging and related assessments.

Researchers are evaluating the safety and effectiveness of XH-02, an mRNA nucleic acid drug that produces parathyroid hormone PTH in the body, to treat adults with hypoparathyroidism. This condition involves low PTH levels leading to low calcium in the blood. Previous studies have shown that subcutaneous injection of XH-02 is safe and effective, and this expanded phase 2 study aims to confirm these findings in a larger group of patients. Participants will receive different doses of XH-02 by subcutaneous injection. Some will get a single dose ranging from 40 to 160 micrograms, while others will receive multiple doses of 40 to 160 micrograms daily or every other day for a total of five doses. The study includes several groups receiving these different dosing regimens to assess safety and treatment response. Throughout the study, participants will undergo various blood and urine tests to measure PTH levels, calcium, phosphorus, magnesium, vitamin D, and other markers. Safety is monitored by recording adverse events from the first dose up to 30 days for non-serious events and 3 months for serious events. The study will follow participants for these assessments to evaluate both safety and how well the drug works over time.

Researchers are collecting data in women who have been exposed to palopegteriparatide during pregnancy to understand the risks to the mother, fetus, and infant. This observational registry study aims to assess pregnancy outcomes, maternal complications, and any adverse effects on the developing fetus, newborn, and infant up to at least one year of age. The study focuses on women with hypoparathyroidism who have been treated with this medication around conception or during pregnancy. Participants include pregnant women who have taken at least one dose of YORVIPATH palopegteriparatide within 15 days before conception or during pregnancy. The medication is prescribed according to normal clinical practice. The study gathers data from these women without altering their treatment and includes only those who provide informed consent or assent with parental consent as applicable. During the study, researchers will collect information on the number of fetuses, pregnancy outcomes, congenital malformations, adverse events, hospitalizations, growth and development milestones, signs of calcium imbalance, infant developmental issues, mortality, and maternal complications. Data will be tracked up to 21 months after exposure to understand both short- and longer-term effects. Participants will provide medical information through healthcare providers, and ongoing monitoring will support safety assessments throughout this period.

This research aims to study and treat individuals with various bone and mineral disorders at the NIH Clinical Center. It provides an opportunity to collect bone specimens for research and to increase knowledge of skeletal diseases, supporting further studies in bone biology. Participants include those with both common and rare bone and mineral metabolism disorders, with evaluations tailored to each diagnosis. Participants receive standard care evaluations and treatments for their bone conditions, without experimental procedures. Assessments include medical history, physical exams, blood and urine tests, and imaging such as X-rays, CT scans, MRIs, bone densitometry, and bone scans. Bone samples may be collected during planned surgeries or through bone biopsies as part of participant evaluation. Throughout the study, participants undergo medical assessments and specimen collection at times specific to their diagnosis. Researchers analyze clinical and research specimens, including genetic and biochemical evaluations of surgical waste materials. The study also aims to create a database of participant information and biological samples to support future research. Participation duration and specific procedures vary by individual needs.

Researchers are evaluating the efficacy and safety of Pacitol Injection paricalcitol in patients with secondary hyperparathyroidism who have stage 5D chronic kidney disease and are receiving hemodialysis. This observational study aims to understand how this medication affects parathyroid hormone levels and other related health measures in this specific patient group. The study is sponsored by Boryung Pharmaceutical Co., Ltd. Participants are hemodialysis patients scheduled to receive Pacitol Injection according to product guidelines. The study observes their response to the medication over time without altering their treatment. The primary measurement is the proportion of subjects whose parathyroid hormone levels meet therapeutic targets 12 weeks after starting the medication. Secondary measurements include hormone levels at 24 weeks, changes in hormone levels compared to before treatment, incidence of anemia, and changes in calcium and phosphorus levels. During the study, participants will be monitored at regular intervals up to 24 weeks to assess hormone levels and other health indicators. Researchers will collect data on safety and efficacy outcomes, including the occurrence of anemia and changes in mineral metabolism. Participants must understand and cooperate with study procedures and complete the study. The study is expected to conclude in April 2026.

Researchers are evaluating the safety, tolerability, and effectiveness of EXT608 in adults with hypoparathyroidism, a condition characterized by low parathyroid hormone levels affecting calcium balance. This Phase 2, multicenter, randomized, double-blind, placebo-controlled trial aims to better understand how this modified parathyroid hormone attached to vitamin D may work in this population. The study is sponsored by Extend Biosciences Inc. and focuses on adults aged 18 to 65 years who have had hypoparathyroidism for at least 12 months. Participants will receive either EXT608 or a placebo via subcutaneous injection once a week. The trial includes a multiple ascending dose phase, starting with a 50 microgram dose for 4 weeks, followed by individualized dosing for another 8 weeks. The placebo group will receive fixed doses for 4 weeks, then variable doses for 8 weeks. This dosing schedule allows researchers to assess the medications effects at different dose levels and monitor participants closely. During the 12-week treatment period, participants will be monitored for safety and tolerability through tracking of adverse events and laboratory tests. Researchers will also assess pharmacokinetics, serum calcium levels, and calcium supplementation needs. Participants will be asked to comply with study procedures, including using a smartphone diary to record medication doses and symptoms. The trial includes detailed evaluation of laboratory results and clinical outcomes to better understand the impact of EXT608 for hypoparathyroidism.

This trial evaluates the safety and treatment effects of palopegteriparatide at doses above 30 mcgday in adults with hypoparathyroidism. It focuses on adults already receiving palopegteriparatide at doses of 30 mcgday or higher, aiming to provide more evidence about treatment impact and safety. The study is conducted in the United States and is a Phase 3 randomized clinical trial. Participants receive daily subcutaneous injections of palopegteriparatide, with dosing individually adjusted through either a novel or previously tested titration algorithm. All participants receive the active drug during the 78-week treatment period. The trial compares two dosing algorithms to find an optimal dose for each participant. Throughout the study, participants are monitored for efficacy primarily at 26 weeks and continue treatment for a total of 78 weeks. Assessments include laboratory tests to confirm vitamin D, magnesium, and calcium levels, as well as safety and tolerability evaluations. The trial aims to understand how well the drug works and its safety profile over this extended period.

Researchers are evaluating the use of etelcalcetide to treat secondary hyperparathyroidism SHPT in children and adolescents aged 2 to under 18 years who have chronic kidney disease CKD and are on hemodialysis. This phase 3 study aims to assess the drugs effectiveness, safety, how it is processed by the body pharmacokinetics, and how it affects the body pharmacodynamics in this pediatric population. Participants will receive etelcalcetide alongside their standard care. The treatment involves multiple doses with titration to find the right dosage. The study is open-label and single-arm, meaning all participants receive the medication and are monitored over time. The trial includes treatment periods lasting up to 31 weeks. During the study, participants will undergo regular assessments including blood tests to measure changes in parathyroid hormone levels, calcium, and phosphorus. Researchers will monitor drug levels in the blood before and after dialysis sessions, track any side effects, and evaluate safety. The main outcome is the percent change in intact parathyroid hormone from baseline between weeks 20 to 26. The total participation time varies but includes ongoing monitoring throughout the treatment period.

This observational study focuses on lactating female participants who are receiving therapeutic doses of YORVIPATH palopegteriparatide as part of their usual medical care and who have chosen to breastfeed their infants. The purpose is to assess the potential transfer of palopegteriparatide into breast milk, providing important information about exposure during breastfeeding for females with hypoparathyroidism. Participants in this study are lactating females treated with YORVIPATH according to normal clinical practice. The study observes those who have been on a stable daily dose of YORVIPATH for at least 14 days prior to sample collection. This is an opportunistic study that does not involve changes to their treatment but monitors the presence of the drug in breast milk over a six-day period. During the study, participants provide breast milk samples to evaluate the transfer of palopegteriparatide. The main outcome measured is the amount of the drug present in breast milk over six days. Participants continue their usual care and dosing schedules, and researchers collect data without altering treatment. The total participation duration depends on dosing stability and sample collection timing, with no additional interventions beyond monitoring.