Hypercalcemia

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 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 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.

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.

Researchers are evaluating a new tool called VISOR in adults aged 18 to 80 who have kidney or ureter stones measuring 1 to 3 cm. The study aims to determine if VISOR is safe and effective in clearing stones during surgery by using its built-in features such as flushing, suction, pressure control, and stone-breaking and removal. The main questions are whether VISOR can clear stones successfully for at least 90% of participants within 24 hours after surgery, keep serious complications below 5%, and maintain safe pressure levels inside the kidney during the procedure. All participants will undergo stone removal surgery using the investigational VISOR device. This device integrates irrigation and suction with real-time pressure monitoring to keep kidney pressure below 30 mmHg during surgery. It uses a holmium laser to break stones while simultaneously removing fragments. After surgery, participants will have a CT scan within 24 hours to check if stones are cleared, followed by a follow-up imaging test (CT or ultrasound) around 4 weeks later to monitor any complications and the longer-term stone-free rate. Participants will be closely monitored during and after surgery with continuous pressure tracking and assessments for any ureteral injuries or infections. They will attend a follow-up visit about 4 weeks after surgery for imaging and health evaluation related to the procedure. Researchers will measure the immediate and 1-month stone-free rates, operative time, intraoperative kidney pressure, and rates of complications to evaluate the safety and effectiveness of VISOR. Total participation includes surgery, immediate post-op imaging, and follow-up within about one month.

Researchers are evaluating the effects of amorphous calcium carbonate (ACC) on bone mineral density (BMD) in postmenopausal women, comparing results with those from the FREEDOM substudy. This study focuses on women aged 60 to 90 years who have a BMD T-score between -4.0 and -2.5. It aims to assess ACC's impact both with and without the addition of Denosumab treatment, an osteoporosis therapy, in an open-label setting. Participants are assigned to one of two groups: the A arm includes women who meet National Health Insurance (NHI) criteria for Denosumab and receive 5 ACC tablets daily plus a 60 mg Denosumab injection every 6 months; the B arm includes women who do not meet NHI criteria or prefer not to receive Denosumab and take 5 ACC tablets daily only. All participants with certain vitamin D levels receive daily vitamin D3 supplements. The study spans 7 clinic visits over 24 months, including screening, treatment start, and follow-up visits. During visits, researchers perform BMD assessments and blood draws at baseline and months 1, 6, 12, and 24. They monitor changes in lumbar spine BMD as the primary outcome, along with overall BMD and bone turnover markers over 2 years. Participants are expected to comply with vitamin D intake limits and complete study procedures, allowing researchers to evaluate the effects of ACC with or without Denosumab on bone health.

Researchers are studying ways to improve the detection of parathyroid tumors in people with primary hyperparathyroidism, including sporadic and heritable forms, as well as parathyroid cancer. This trial evaluates whether PET/MRI and NeuroEXPLORER PET/CT scans using an 18F-Fluorocholine (18F-FCH) tracer provide better localization of parathyroid glands compared to the current standard, 4-dimensional computed tomography (4D-CT). The study is conducted by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and aims to measure the positive predictive value of these imaging methods. Participants will receive an injection of the 18F-FCH tracer before undergoing PET/MRI and NeuroEXPLORER PET/CT scans, after which their vital signs will be monitored during the procedures. They will also have a 4D-CT scan with an iodine-based contrast dye, which is the current standard for locating parathyroid glands. Following the imaging, participants will undergo surgery to remove the affected parathyroid gland, and may stay in the hospital for up to three nights. The study includes up to four visits, including screening and follow-up. During the study, participants will have physical exams, blood samples taken, and the imaging tests described above. After surgery, a follow-up visit will occur about six months later, which may be conducted remotely. The main outcomes measured are the accuracy and predictive value of the new PET/MRI and PET/CT scans compared to the standard 4D-CT. Researchers will also monitor participant safety and recovery throughout the study period, which may last up to several years until final data collection in 2036.

Researchers are conducting a study called Acutelines, a large data and biobank project at the University Medical Center Groningen in the Netherlands. It focuses on patients with a wide range of acute medical conditions who present to the Emergency Department. The goal is to improve how acute diseases are recognized and treated, understand their outcomes, and support personalized medicine by collecting detailed clinical data, imaging, and biomaterials over time. Participants have their medical information, including demographics, health status, medical history, vital signs, diagnostic tests, and treatments, systematically collected. Biomaterials such as blood, urine, feces, and hair are gathered from patients who meet certain severity criteria. Data collection occurs during hospital admission, including continuous monitoring, and continues with follow-ups at 3 months, 1 year, 2 years, and 5 years after the initial emergency visit. Throughout the study, various assessments are performed, such as quality of life, physical functioning, mental health, symptoms, and hospital length of stay. Researchers collect data on mortality and other health outcomes for up to 50 years. The study uses digital tools to automate data capture and integrates information from multiple healthcare sources. Participants will be monitored closely during hospitalization and at scheduled intervals afterward to help improve understanding and treatment of acute diseases.

Researchers are evaluating the potential usefulness of 11C/18F-MET/FET positron emission tomography/computed tomography (PET/CT) imaging for diagnosing primary and metastatic lesions in patients with various amino acid transporter system (AATS)-related diseases, including primary hyperparathyroidism and glioma. The study aims to measure how well this imaging method detects these lesions by analyzing uptake values and diagnostic accuracy. Each participant receives a single intravenous injection of the 11C/18F-MET/FET tracer, followed by PET/CT imaging within a specified time frame. This observational study involves patients undergoing the scan either for initial assessment or to detect recurrence of disease. The imaging uptake in lesions will be quantified using the maximum standardized uptake value (SUVmax). Participants will be evaluated with PET/CT scans, and the researchers will assess diagnostic measures such as sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy. The primary outcome is the standardized uptake value measured within 30 days, along with diagnostic efficacy. The total study period extends up to the end date in 2033, with assessments occurring shortly after imaging.

Researchers are evaluating the effects of a single infusion of zoledronic acid (ZOL) compared to placebo in patients with primary hyperparathyroidism (PHPT) undergoing parathyroidectomy (PTX). PHPT is an endocrine disorder characterized by high calcium levels, reduced bone density, increased fracture risk, kidney calcifications, and cardiovascular problems. The study aims to determine if ZOL given before surgery influences bone health, cardiovascular measures, and kidney function one year after PTX. Participants will be randomly assigned to receive either a 4 mg intravenous infusion of ZOL or a placebo saline solution 2 to 4 weeks before their PTX surgery. The trial is double-blinded, so neither patients nor researchers know who receives which treatment. All patients will be advised to take daily calcium and vitamin D supplements after surgery. The study includes extensive imaging such as DXA, high-resolution CT scans, cardiac CT, and ultrasounds, along with blood and urine tests to assess bone density, bone microarchitecture, biochemical markers, coronary artery calcium score, arterial stiffness, and renal calcifications. Participants, who are postmenopausal women or men over 50 with PHPT and low bone density, will be assessed at baseline and again one year after surgery. They will complete questionnaires on symptoms and quality of life. Safety monitoring includes tracking side effects, blood tests, and scans. The primary outcome is the change in bone mineral density at the lumbar spine one year after PTX. Secondary outcomes include bone density changes at other skeletal sites, bone turnover markers, cardiovascular measures, and kidney calcifications. The study duration for participants is approximately one year after surgery.