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 imaging method with Fluorine-18 bound to Choline to detect parathyroid adenomas in participants who have elevated calcium and abnormal parathyroid hormone levels but whose standard 99mTc Sestamibi SPECT/CT scans are negative or unclear. This single-center, single-arm trial focuses on improving detection of suspected parathyroid adenomas. Participants will receive an intravenous injection of 18F Fluorocholine at a dose of 5 mCi ± 20%. About 45 to 60 minutes after the injection, they will undergo a low-dose CT scan from the skull base to mid thighs, followed by a static PET emission scan over the same region. The study does not use a comparison group or placebo. During the study, researchers will monitor the number of parathyroid lesions detected by PET/CT within one hour after imaging. Participants will be assessed for liver and kidney function, and their physical status will be evaluated. Safety monitoring includes checking heart rhythm and confirming pregnancy status for women. The trial is expected to continue until July 2027, and participants will be closely observed during and shortly after the imaging procedure.

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.

Researchers are studying individuals with bone and mineral disorders to better understand these conditions and improve knowledge about bone biology. The study allows patients with various skeletal diseases to be evaluated and treated at the NIH Clinical Center, while also offering training opportunities for NIH trainees. The research includes collecting bone specimens from patients to support further study of bone diseases. Participants receive evaluations that include medical history reviews, physical exams, and standard tests such as blood and urine analysis, X-rays, bone densitometry, bone scans, CT scans, and MRI. Bone samples may be collected either from tissue removed during planned surgical procedures or via bone biopsy as part of the evaluation. No experimental treatments or tests are involved; all procedures are part of routine care for skeletal diseases. Throughout the study, patients undergo clinical assessments tailored to their diagnosis at specific times. Researchers collect and analyze clinical data and biological specimens, including genetic and biochemical tests on surgical waste material. The study aims to build a database containing detailed information and specimens from participants to support future research. Participation duration and specific assessments vary depending on each participant's condition and 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 medication's 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.

Researchers are evaluating the safety, tolerability, and effectiveness of palopegteriparatide at doses greater than 30 mcg per day in adults with hypoparathyroidism. This phase 3 trial focuses on adults who have been living with chronic hypoparathyroidism for at least 26 weeks and are already receiving treatment with palopegteriparatide at doses of 30 mcg/day or higher. The study aims to provide more evidence on the treatment effects and safety of higher doses of this medication. Participants will receive subcutaneous injections of palopegteriparatide once daily, with doses starting at or above 30 mcg. They will be randomly assigned to one of two groups using different dose titration algorithms to find an optimal dose. Both groups receive the same medication delivered by a prefilled pen designed for single-patient use. The treatment period lasts for 78 weeks, during which the dose may be progressively adjusted based on individual needs. Throughout the study, participants will have regular visits to monitor safety and treatment effects, including laboratory tests to check calcium levels and other relevant biomarkers. The primary outcome focuses on treatment efficacy measured after 26 weeks. The trial includes ongoing monitoring of laboratory parameters and safety assessments, with participation lasting up to 78 weeks in total. This helps researchers better understand how the medication works at higher doses in adults with hypoparathyroidism.

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 drug's 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.

Researchers are conducting an observational study to understand how much palopegteriparatide passes into breast milk in lactating women who are being treated with YORVIPATH for hypoparathyroidism. The study focuses on women who have chosen to breastfeed while receiving this medication as part of their usual care. It aims to provide important information about the medication's transfer during breastfeeding. Participants in this study are lactating females currently taking palopegteriparatide under normal clinical care. The study observes these women without altering their treatment, tracking the medication levels in breast milk. The main study period lasts 6 days during which breast milk samples will be collected to evaluate the transfer of the drug. During participation, women will provide breast milk samples over the 6-day observation period. Researchers will assess the amount of palopegteriparatide in the milk to understand potential exposure to infants. Participants must have stable doses of the medication and primarily breastfeed their infants. The study includes informed consent and follows the participants' usual medical care throughout.