Hyperparathyroidism

Researchers are investigating the effectiveness of the "Pontic-shield" technique in preserving the alveolar ridge after tooth extraction. This study compares this technique with two other approaches: ridge preservation using deproteinized bovine bone and a porcine collagen membrane, and no intervention after extraction (fresh socket). The trial aims to understand which method better maintains bone structure, addressing challenges in long-term dental implant success. The study is a three-arm randomized clinical trial. Participants are assigned to one of three groups: the experimental group receiving the "Pontic-shield" technique, where a 1mm thick fragment of the tooth root is left in place; the positive control group receiving ridge preservation with bovine bone and collagen membrane; and the negative control group receiving no insertion after extraction, allowing the blood clot to form naturally. A cone-beam computed tomography scan is done before extraction and again four months after to evaluate bone changes. Participants will undergo tooth extraction and assigned treatment. Their bone resorption is measured from extraction day to four months after. Satisfaction is also assessed using a visual analogue scale during the first week post-surgery. The study includes adults aged 18 to 80 who require extraction of specific teeth and agree to participate. Safety and healing are monitored throughout. Total follow-up lasts at least four months after extraction to assess outcomes.

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 TS-172 in adults with hyperphosphatemia who are receiving hemodialysis due to chronic kidney disease. This open-label, single-arm clinical study aims to assess how well TS-172 controls serum phosphorus levels in this patient group. The study is sponsored by Taisho Pharmaceutical Co., Ltd. and focuses on patients who have been on hemodialysis three times a week for at least 12 weeks. Participants will receive oral TS-172 once daily at doses ranging from 20 to 60 mg. The study monitors the achievement rate of target serum phosphorus levels by Week 8. Secondary measures include changes in serum phosphorus concentration, corrected serum calcium levels, and the serum calcium-phosphorus product up to Week 8. During the study, participants will undergo regular blood tests to measure phosphorus and calcium levels and monitor parathyroid hormone concentrations. Researchers will track changes from baseline to evaluate treatment effects. The study does not involve blinding or placebo groups. Participants will be followed from screening through Week 8 to assess safety and efficacy outcomes.

Researchers are evaluating the long-term safety and effectiveness of the drug TS-172 in patients with hyperphosphatemia who are undergoing hemodialysis. This Phase 3 study focuses on patients who have chronic kidney disease and have been receiving hemodialysis or hemodiafiltration three times a week for at least 12 weeks. The study is sponsored by Taisho Pharmaceutical Co., Ltd. and aims to assess the impact of TS-172 on controlling phosphate levels. Participants will receive oral TS-172 at doses ranging from 20 to 60 mg per day while continuing their prescribed phosphate binder regimen without changes in dosage during the study. The trial includes a treatment period lasting up to 52 weeks to monitor the drug's safety and efficacy in managing serum phosphorus levels within a specified range. No placebo or comparator groups are mentioned, and the study is open-label without masking. During the trial, participants will have regular assessments to monitor adverse events and serum phosphorus concentrations. The primary outcome measure is the incidence of adverse events within 26 to 52 weeks of treatment. Patients must meet specific eligibility criteria regarding their dialysis treatment, phosphate binder use, and serum phosphorus levels. The total participation duration will be at least one year from the start of treatment, with safety monitored throughout the study period.

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 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 a phase 3 trial to study TS-172, an oral drug, in patients with hyperphosphatemia who are on hemodialysis. The study is designed as randomized, placebo-controlled, and double-blind to evaluate the effect of TS-172 combined with phosphate binders. The purpose is to understand how well TS-172 controls serum phosphorus levels in this patient group. Participants will receive either TS-172 at doses of 20 to 60 mg per day or a placebo, both given by mouth. The study involves continuing the use of phosphate binders at stable doses during the trial. The treatment period lasts up to 8 weeks, during which the impact on phosphorus and calcium levels will be assessed. During the trial, participants will have their serum phosphorus, corrected calcium, and calcium-phosphorus product measured regularly, with the main focus on achieving target phosphorus levels by week 8. The study includes careful monitoring of parathyroid hormone levels and follow-up visits to ensure safety and track treatment effects. Overall participation spans the treatment period and related assessments up to 8 weeks.

Brain calcification is a common finding seen in various conditions including metabolic, neurological, developmental disorders, infectious diseases, trauma, toxic exposures, and also in normal aging. Researchers aim to better understand the clinical and genetic features of brain calcification by following a group of people with this condition over time. This observational study is designed to gather long-term information about brain calcification and its hereditary aspects. Participants include patients who have brain calcium deposits confirmed by CT scans, their relatives, and unrelated healthy individuals. The study involves observing and collecting data without any treatment intervention. The cohort will be followed for up to 20 years to monitor the occurrence and characteristics of hereditary brain calcification. During the study, participants will undergo assessments including CT scans to measure calcification levels and regular follow-ups to track changes. Researchers will record the incidence of hereditary brain calcification and gather clinical and genetic data. The study also involves obtaining informed consent and ensuring participants adhere to scheduled visits and procedures throughout the observation period.