14 Clinical Trials for Various Conditions
The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering corrected serum calcium \</= 11.5 mg/dL (2.9 millimoles /L) by day 10.
RATIONALE: Zoledronate may help to relieve some of the symptoms caused by bone metastases. It is not yet known if zoledronate is more effective than no further therapy in relieving symptoms of bone metastases or preventing disease progression. PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in treating patients who have solid tumors that have spread to the bone.
This is a dose escalation study to determine the maximum tolerable dose of Parathyroid Hormone-related Protein, PTHrP, or Parathyroid Hormone, PTH, that can be given safely over one week in healthy African-American volunteers. The investigators plan to infuse low doses of intravenous PTHrP or PTH to determine if it leads to a sustained and progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy (HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally, the investigators will assess the direct influence of PTHrP and PTH on vitamin D metabolism, markers of bone turnover, and fractional excretion of calcium. These results will be compared to previous studies of Caucasian volunteers.
This is a dose escalation study to determine the maximum tolerable dose of Parathyroid Hormone-related Protein, PTHrP, that can be given safely over one week. The investigators plan to infuse low doses of intravenous PTHrP to determine if it leads to a sustained and progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy (HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally, the investigators will assess the direct influence of PTHrp on markers of bone turnover, and plasma 1,25 (OH)2 vitamin D regulation in healthy human volunteers.
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. It is not yet known whether monoclonal antibody is more effective than zoledronate in treating women who have breast cancer and bone metastases. PURPOSE: Randomized phase I/II trial to compare the effectiveness of monoclonal antibody with that of zoledronate in treating women who have breast cancer and bone metastases.
The purpose of this registry is to create a database that collects clinical data to improve knowledge about primary hyperparathyroidism.
This study is intended to evaluate the safety, tolerability, and possible effectiveness of an investigational humanized monoclonal antibody (CAL) to the parathyroid hormone-related protein (PTHrP) when compared to zoledronic acid in patients with breast cancer metastatic to bone. The study will also evaluate the possible effects of both study drugs on performance status, markers of bone metabolism, and skeletal events related to bone metastasis including elevated blood calcium levels, bone pain, metastatic lesions, complications and interventions. The levels of CAL in the blood will also be evaluated.
This study will evaluate the benefits and side effects of a new medication called Cinacalcet for treating patients with primary hyperparathyroidism associated with multiple endocrine neoplasia type 1 (MEN1) or type 2A (MEN2A). Patients with primary hyperparathyroidism have elevated levels of blood calcium caused by too much parathyroid hormone released by one or more parathyroid tumors. The parathyroids are small glands located in the neck. Most cases of primary hyperparathyroidism are due to a single overactive parathyroid gland, but in MEN1 and MEN2A, several glands are overgrown and overactive. Cinacalcet decreases the secretion of parathyroid hormone. Patients 18 years of age and older with primary hyperparathyroidism and MEN1 or MEN2A and who are not candidates for parathyroid surgery may be eligible for this study. Participants are admitted to the Clinical Center for 1 week blood and urine tests and imaging studies, and initiation of Cinacalcet treatment. They take the drug by mouth and have daily blood tests until the dosage required to achieve normal blood calcium levels is determined. Patients return to the hospital 2 weeks later for 1 week to evaluate the response to the drug and make any necessary adjustments. Treatment may continue for as long as 1 year with 1-week admissions every 3 months to monitor the benefits and side effects of Cinacalcet. Evaluations may include the following: * Blood and urine analyses. * Measurement of gastric acid secretion. For this test, a soft plastic tube is inserted into the nose or mouth and then swallowed and then gently removed about an hour later. * Injections of secretin, calcium and arginine into a vein and collection of blood samples to measure the responding increase in levels of gastrin, calcitonin and insulin, respectively. These tests are used to diagnose and monitor hormone secretion from endocrine tumors and are used in this study to assess the response to Cinacalcet treatment. * Radioisotope test to evaluate tumors of the endocrine organs. A radioactive substance injected into a vein is taken up by the endocrine tissue and the concentrated radioactivity is measured. * Imaging tests, such as MRI and CT, to detect or follow growing tumors in the pituitary, neck, and abdomen. CT is a special type of x-ray machine that visualizes tissues, such as thyroid or parathyroid tumors. MRI uses a magnetic field and radio waves to obtain pictures of different tissues in the head, neck and abdomen. * DEXA scan to assess bone density. This test uses standard low-intensity x-rays.
Diseases of mineral metabolism such as familial multiple endocrine neoplasia type 1 (FMEN1), familial hypocaliuric hypercalcemia (FHH), familial hyperparathyroidism (FH), and pseudohypoparathyroidism (PHP) are known as hereditary abnormalities. Meaning these conditions are passed from parents to their children through genes. These specific conditions result in abnormal levels of calcium in the blood. This study was designed to help researchers understand more about the genes that are responsible for these disorders. By learning more about the genetic process involved in hereditary abnormalities, new tests and treatments can be developed. Subjects for this study will be members of families that have had relatives diagnosed with a disease of mineral metabolism. Participants will be asked to give blood samples for DNA extraction. DNA is the part of cells that carries genetic information. The DNA will be analyzed and the results given to the subjects. Genetic counseling will be provided to subjects to aid in interpreting their results....
The goal of this study is to assess whether using PTeye (AiBiomed, Santa Barbara, CA) - a NIRAF detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries. By being able to quickly and definitively locate parathyroid glands while in the operating room, the duration of surgical procedure could be further reduced. In addition, the number of frozen section biopsy and associated costs can be minimized. Furthermore, repeat surgeries as a result of missing a diseased parathyroid gland at the time of the initial parathyroidectomy for hyperparathyroidism could potentially be avoided.
This study will see if the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
Observational Phase: Patients whose parathyroid activity is elevated above normal are referred to as having hyperparathyroidism. This study will help researchers better understand the causes of hyperparathyroidism and to evaluate and improve methods for diagnosis and treatment. Patients diagnosed with or suspected of having hyperparathyroidism will be selected to participate. In addition, patients with related conditions, such as parathyroid tumors, will also be selected. Subjects will be asked to provide blood and urine for testing to confirm their condition. They will then be surgically treated by removal of the parathyroid gland(s) (parathyroidectomy). Subjects with parathyroid tumors will undergo several diagnostic tests to determine the exact location of the tumor as well as the tumor's activity. The tests may include; ultrasounds, nuclear scanning, CT scans, MRI, and specialized blood testing. Sometimes parathyroidectomy leads to hypoparathyroidism. Options for treating the patients after the surgical procedure will also be addressed. Calcium and Vitamin D supplements are typically the mainstay of post parathyroidectomy therapy. Other potential treatments include transplanting the parathyroid gland(s) to other areas of the body. Clinical Trial: An imaging substudy was added to this protocol in 2018. Patients with multiple endocrine neoplasia type 1 (MEN1) will have 68Gallium-Dotatate Positron Emission Tomography (PET) - Computed Tomography (CT), 18F-DOPA PET/CT, MRI, and CT scans and the number of lesions detected by each of these types of scans will be compared.
This phase II trial studies the side effects and how well tivantinib works in treating patients with relapsed, or relapsed and refractory multiple myeloma. Tivantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.