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Showing 1-20 of 24 trials
NCT00743782
This randomized crossover study will evaluate the safety, efficacy, and pharmacodynamics of synthetic human PTH 1-34 (PTH) delivered by an insulin pump (omnipod) compared with twice- daily subcutaneous injections. We predict pump delivery of PTH will simultaneously normalize blood and urine mineral levels with minimal or no fluctuations throughout the day, thus resulting in a more physiologic pharmacodynamic profile because this method of delivery mimics normal parathyroid gland function. Furthermore, we hypothesize that pump therapy will require lower PTH doses and will normalize markers of bone turnover. We anticipate the improved metabolic control when PTH is delivered by pump will be evident both in adults with surgically induced hypoparathyroidism and in children with more severe forms of hypoparathyroidism where there is an unmet need for improved therapy.
NCT07345494
The purpose of this registry study is to collect both prospective and retrospective data in women exposed to palopegteriparatide during pregnancy to assess risk of pregnancy and maternal complications, and adverse effects on the developing fetus, neonate, and infant and to assess infant outcomes through at least the first year of life.
NCT06961071
This study is being done to see if transplanting parathyroid tissue into the forearm will help hypo-parathyroid patients achieve parathyroid hormone (PTH) levels that would help normalize their serum calcium and phosphorus levels. The parathyroid tissue used in this study will come from cadaveric tissues that were donated at the time of the death of the donor(s).
NCT07395388
This randomized controlled trial aims to evaluate the efficacy of intraoperative methylene blue (MB) spray in improving the identification and preservation of the recurrent laryngeal nerve (RLN) and parathyroid glands (PGs) during thyroidectomy. The study compares outcomes between patients receiving topical MB spray and those undergoing conventional visual dissection alone. Primary outcomes include the incidence of RLN injury and postoperative serum calcium levels.
NCT05793853
This is a prospective three-year natural history study of adults with hypoparathyroidism. The goal is to monitor patients with hypoparathyroidism to define end-organ damage in the context of the disease. The study objectives are to: 1. Build a prospective cohort of patients to study HPT-associated end-organ damage. 2. Determine end-organ physiologic consequences of HPT. 3. Elucidate determinants of HPT-associated end-organ damage. Funding Source - FDA OOPD
NCT07197450
This study aims to evaluate the safety and efficacy of a novel PTH replacement therapy drug in patients with hypoparathyroidism. The drug is an mRNA drug which will be translated into PTH after intravenous administration, to achieve the therapeutic effect.
NCT01922440
The main aim of this study is to find out the long-term safety and effectiveness profile of recombinant human parathyroid hormone (1-84) (rhPTH\[1-84\]) treatment in participants with chronic hypoparathyroidism under conditions of routine clinical practice. Participants will be treated according to their clinic's standard practice determined by the treating doctors. Each participant will fill out a study questionnaire during a routine doctor visit.
NCT07160348
This is a crossectional study that will be conducted at several tertiary centers in Greece. To participate in the study, patients should be ≥18 years of age, fluent in Greek language, diagnosed with chronic HP, on optimal treatment with calcium and active vitamin D metabolites. Chronic HP is defined when continuous therapy with calcium and vitamin D is required for \>12 months. Exclusion criteria will include: 1. Patients inadequately controlled with conventional therapy: 1. corrected serum Ca (cCa) ≤8 mg/dl or cCa ≤8.2 mg/dl with symptoms of hypocalcemia 2. serum P \>5.5 mg/dl 2. Age \>80 years 3. Presence of neoplastic disease 4. Pregnancy 5. Diagnosis of psychiatric disease or cognitive impairment 6. Participants experiencing other comorbidities that may affect QoL 7. Lack of informed consent The study will seek approval from the Ethics in Research Committee of its participating center. All participants will be informed about the objectives of the study and will sign an informed consent. The HPES-Symptom was developed in accordance with the Food and Drug Administration guidance and best research practices for PRO measure development. The methodology used has been previously described. The first step of the translation process requires two forward translations of the English version of the questionnaire. The translations will be done by two translators who are native speakers of the target (Greek) language and can understand the English version. Then a reconciled translation is made based on the two translations - that is, the chief investigator will review the two translations to achieve the best possible version by choosing one of the two translations or by combining them on the basis of their correctness, wording etc. The next step requires translating the reconciled version back into English, again done by two translators who will be native speakers of English or at least will have a very good command of English.
NCT06765941
The goal of this randomized clinical trial is to learn if there are any added benefits of using near-infrared autofluorescence (NIRAF) probe-based imaging system (the PTeye) for intraoperative identification of parathyroid glands (PGs) during thyroid surgery in comparison to visual identification of PGs by the surgeon's naked eyes without PTeye. The main questions it aims to answer are: * Is number of PGs identified intraoperatively and preserved in situ larger in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? * Is number of patients with undetectable or low parathormone serum level on postoperative day 1 fewer in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? * Is number of patients requiring substitution therapy with calcium and vitamin D analogue fewer after thyroid operations with PTeye versus surgeon's naked eyes without PTeye in a short-term (\< 6 weeks) and/or in a long-term (at 6 months) follow-up? * Is numer of inadvertenly removed and reimplanted PGs fewer in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? * Is number of frozen sections fewer in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? * Is number of PGs identified by pathologist in the surgical specimen fewer in in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? * Is number of patients with symptomatic hypoparathyroidism within 30 days of the operation fewer in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? The hypothesis explored in this study is that use of PTeye in comparison to the surgeon's naked eyes may be beneficial for intraoperative identification and preservation of PGs in thyroid surgery leading to reduced risk of postoperative hypoparathyroidism. A prospective, randomized study with 2 arms: use of PTeye vs. visual identification of PGs without PTeye (n=77 patients, each). The primary outcome measure is number of intraoperatively identified PGs with use of PTeye vs without it.
NCT05022667
This study will see if the use of near infrared autofluorescence (NIRAF) detection with a 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during total thyroidectomy (TTx) is better than surgeon's detection alone. It compares risk, benefits and outcomes in TTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
NCT06579430
Background Near-infrared fluorescence guided surgery with indocyanine green (ICG) was introduced for parathyroid perfusion assessment during total thyroidectomy in 2016. ICG can visualize tissue perfusion, since it becomes completely and permanently fixed to plasma proteins in the bloodstream, and circulates in the intravascular compartment only. ICG was already approved in 1956 for clinical use of tissue perfusion. However, until now there is still no (parathyroid) universal standard imaging protocol for ICG-guided fluorescent surgery including quantitative evaluation. Main research question To develop a standardized universal imaging protocol for the assessment of parathyroid perfusion during total thyroidectomy with ICG including quantitative evaluation of the fluorescent signal. • Design (including population, confounders/outcomes) This will be a proof-of-concept, prospective cohort study of patients undergoing an ICG-guided fluorescent total thyroidectomy to evaluate parathyroid gland perfusion. The main study endpoint is quantification of the fluorescent signal of ICG stratified by the occurrence of hypoparathyroidism. Hypoparathyroidism will be defined as a decrease in PTH of \>70% at the first postoperative day. Furthermore, we will calculate the sensitivity of our model for the prediction of hypoparathyroidism. Secondary outcomes are data from surgery, pre- and postoperative lab values (including calcium, PTH, albumin) and postoperative medication use. Expected results We expect that the results of this study will lead to the development of a universal standard imaging protocol for ICG-guided fluorescent total thyroidectomy.
NCT06499246
Hypoparathyroidism following thyroid surgery presents significant challenges, often leading to debilitating symptoms and reduced quality of life despite conventional treatment. Having now reported the first successful case of a deceased donor fresh tissue parathyroid allotransplant with immunosuppression in a transplant-naive recipient, the purpose of this study is to further assess the safety and efficacy of this procedure in patients with severe intractable post-surgical hypoparathyroidism.
NCT06449729
Endocrine determinants of renal function in patients with hypoparathyroidism on conventional treatment: a cross-sectional study (ENDORSE)
NCT06288490
Primary objective: Phase I Proof of concept: treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL). Phase II To test the hypothesis that treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL). Secondary objectives: Phase I * ACC dose selection - to confirm the conversion factor of ACC from CCS * To determine the effect of food on ACC absorption Phase II * To test the hypothesis that treatment with smaller doses of elemental calcium from ACC compared to CCS will not cause an increase in hypercalciuria in patients with hypoparathyroidism * To test the hypothesis that smaller doses of elemental calcium from ACC can reduce the side effects related with high calcium consumption. Amorphical has a strong basis to believe that the ACC product is better absorbed compared to the commercially available CCS products and therefore, can maintain desirable target albumin corrected calcium values in serum (CA) with smaller doses of elemental calcium from ACC. As results, the burden of taking high doses of calcium supplementation along with the side effects of the standard therapy (gastrointestinal discomfort and hypercalciuria) will be reduced. Testing serum CA and urine calcium values in subjects with hypoparathyroidism may provide a straightforward method to test this hypothesis. The study is designed to be conducted with extra precaution in order to avoid disturbing the fragile balance between CA levels in serum and calcium levels urine. The crossover design of phase II of the study allows a more accurate and reliable comparison of results attributable to the specific treatment within the same individual. In addition, the subjects will continue consuming all their routine medication throughout the trial. The subjects in the control arm will consume their routine calcium supplement doses thus, will be treated with a standard of care.
NCT00581828
The purpose is to perform a one-year study designed to assess whether treatment of hypovitaminosis D increases intestinal absorption of calcium, subsequent retention of calcium within bone, decreases bone turnover, and favorably impacts upon skeletal muscle mass, functional status, measures of physical function and quality of life. I hypothesize that treatment of hypovitaminosis D results in improved intestinal calcium absorption, greater retention of calcium within the bone reservoir and improved physical function, quality of life and muscle mass.
NCT04671719
PTH secretion defects (grouped under the name hypoparathyroidism) are due to abnormalities in the PTH gene, abnormalities in the development of the parathyroid glands which synthesize PTH or abnormalities of the calcium sening receptor whose role is to adapt PTH level to ambient calcium level. In contrast, primary hyperparathyroidism in children is also exceptional; expressed by hypercalcemia, with a renal and bon risk. Pseudo-hypoparathyroidism, now known under the term inactivating PTH / PTHrP Signaling Disorder or iPPSD, are rare pathologies characterized by resistance to the action of PTH sometimes associated with other symptoms, in particular chondrodysplasia. They are linked to a defect in the action of a factor in the signaling pathway of G protein-coupled receptors that activate the production of cyclic AMP (cAMP). IPPSDs are most often due to a molecular defect in the GNAS gene, subject to parental imprint. Fibrous dysplasia / McCune-Albright syndrome is a rare disease caused by somatic "gain-of-function" mutations in the GNAS gene located on chromosome 20q13 leading to activation of the protein Gαs and inappropriate production of intracellular cyclic adenosine monophosphate (cAMP). The clinical phenotype is determined by the location and extent of the tissues affected by this mutation. Autotaxin (ATX) is a protein secreted by different tissues including the liver, fatty tissue, and bone. Today, ATX is described as the major source of LPA in the bloodstream. LPA interacts with one of its receptors on the surface of the cell membrane. Depending on the receptor engaged, one or more Gα subunits (G12 / 13, GQ, Gi / o or Gs) will activate multiple cell signaling pathways. In bone, ATX is expressed by osteoclasts and osteoblasts. Recent laboratory data have shown that PTH stimulates ATX expression in osteoblasts in a dose-dependent manner. The objective of this study is to provide clinical proof of concept that the PTH / Gαs / ATX pathway is truly significant in physiology and pathology, by studying the full spectrum of PTH and GNAS pathologies. If this proof of concept is obtained, therapeutic applications will probably be possible in the long term.
NCT02824718
Hypoparathyroidism is a rare condition in which the parathyroid glands fail to produce sufficient amount of parathyroid hormone or the parathyroid hormone produced lacks biologic activity. The most common cause of hypoparathyroidism is damage to or removal of the parathyroid glands due to neck surgery for another condition. Occurrence of hypercalciuria under treatment is a frequent concern in primary hypoparathyroidism, limiting correction of hypocalcemia. Hypoparathyroidism can also be caused by an autoimmune process. In rare cases, hypoparathyroidism may occur as a genetic disorder inherited as an autosomal recessive, autosomal dominant or X-linked recessive trait. The autosomal dominant hypocalcemia (ADH) is mainly caused by heterozygous activating mutations in the CASR gene encoding CaSR). As other severe presentation of primary hypothyroidism, ADH is characterized by the increased risk to develop hypercalciuria and nephrolithiasis. The purpose of the study is to compare two therapeutic approaches in severe hypoparathyroidism in order to limit the risk of nephrocalcinosis and renal failure when attempting to correct hypocalcemia: rhPTH(1-34) vs association of active vitamin D and hydrochlorothiazide. The European Society of Endocrinology Clinical has indeed recently published guidelines for the treatment of chronic hypoparathyroidism in adults. These guidelines suggest considering treatment with a thiazide diuretic In a patient with hypercalciuria and replacement therapy with PTH in patients who do not stably and safely maintain their serum and urinary calcium in the target range.
NCT04690842
We implemented a previously reported algorithm based on intra-postoperative PTH measurements with selected cut-off values, both to predict post-thyroidectomy hypoparathyroid hypocalcemia, and to guide postsurgical management. The objective of the study was to assess if this strategy was useful to reduce hypocalcemia, post-surgery calcium sampling and hospitalization length.
NCT03425747
Hypoparathyroidism is an endocrinopathy characterized by a deficient secretion or action of PTH associated with low calcium level. According to the European guideline (2015), standard treatment includes oral calcium salts and active vitamin D metabolites to relieve symptoms of hypocalcaemia, maintain serum calcium levels in the low normal range and improve the patient's QoL Calcium carbonate is most often used and less expensive than other calcium preparations and contains the highest concentration of elemental calcium per gram (42%). It requires gastric hydrochloric acid to form carbonic acid (H2CO3) that immediately decomposes into water (H2O) and carbon dioxide (CO2). CO2 is responsible for its side effects such as flatulence, constipation and general gastrointestinal disorders. Therefore, in some patients it is better to find an alternative to calcium carbonate. Calcium citrate should be recommended to patients with achlorhydria or on treatment with proton pump inhibitors (PPI) as well as to patients who preferred to take supplements outside mealtimes. furthermore, patients with hypoparathyroidism have an increased risk of kidney stones. Kidney stones are formed by calcium salts, among which the most frequent ones are calcium-oxalate (70-80%), followed by calcium-phosphate and uric acid. Citrate salts are widely used in the treatmentof nephrolithiasis, since have shown an inhibitory effect on kidney stone formation. Up to now, there are no studies aimed to investigate the efficacy of calcium citrate in the management of subjects with chronic hypoparathyroidism. In particular, we will investigate if calcium citrate compared to calcium carbonate does not affect the risk of renal stones, if it is able to maintain normal calcium levels and, if it has an impact on QOL, in subjects with chronic hypoparathyroidism.
NCT04126941
Pediatric hypoparathyroidism is an orphan disease. Conventional management combines native and active vitamin D, calcium supplementation and sometimes phosphate binders, with the risk of long term hypercalciuria, nephrocalcinosis and further renal impairment. The use of teriparatide has been reported in adults (daily or bi-daily subcutaneous infusions) and in children (rather continuous subcutaneous infusion) as second-line therapy. The objective of this study is to obtain efficacy and safety data on the use of teriparatide in children with hypoparathyroidism to improve our knowledge of their management.