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Hypoparathyroidism clinical trials

View clinical trials related to Hypoparathyroidism.

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NCT ID: NCT02652884 Recruiting - Clinical trials for Transient Hypoparathyroidism

Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy

Corthyroid
Start date: January 2016
Phase: Phase 4
Study type: Interventional

The incidence of thyroid cancer (TC) has increased exponentially worldwide. The increase in diagnosed cases brings about an increase in the number of surgeries performed on the thyroid gland, especially total thyroidectomy (TT), given that at present is still the gold standard of treatment. Transient postoperative hypoparathyroidism (HPT) is one of the most frequent complications, with an incidence of between 10 and 46% according to different sources. HPT involves longer hospital stay, serial measurements of blood glucose, treatment with calcium and vitamin D (with potential risk of hypercalcemia) and therefore an increase in terms of the costs of the health system. While the investigators know the analgesic, anti-inflammatory, immunomodulatory and anti emetic of corticosteroids in thyroid surgery, the literature available to date is discordant in the use of steroid and its interaction with the HPT making clear the need for randomized clinical trials specific to analyze these variables more accurately. As inflammation and edema constitute a proposed surgical manipulation in the pathogenesis of HPT component, investigators decided t conduct a prospective randomized, triple-blind, in order to assess the potential benefits of the most common postoperative complication reported in TT. Our primary objective is to evaluate the safety and efficacy of single-dose corticosteroids deposit immediately postintubation in preventing the development of transient hypoparathyroidism (PTH, serum calcium and symptoms) in patients after TT.

NCT ID: NCT02551120 Active, not recruiting - Clinical trials for Pseudohypoparathyroidism

Characterization of Patients With Non-surgical Hypoparathyroidism and Pseudohypoparathyroidism

Start date: June 2014
Phase:
Study type: Observational

Hypoparathyroidism (hypoPT) and pseudohypoparathyroidism (Ps-hypoPT) are rare diseases, characterized by low levels of parathyroid hormone [PTH] and plasma calcium or high plasma PTH and low plasma calcium, respectively. A recently study by the investigators' group, identified 123 living persons with idiopathic hypoPT and 62 living persons with Ps-hypoPT, only few of these have been genetic tested. The aim of the study is to perform a detailed clinical and genetic characterization of Danish patients with idiopathic hypoPT and Ps-hypoPT. Patients will be examined by questionnaires, biochemistry, scans, bone biopsies and genetic tests. Furthermore the investigators aim to perform family tracing for the hereditary forms. The prevalence of magnesium depletion will be assessed as well. In addition to providing new information on symptoms, co-morbidity, and prognosis for this group of patients, the investigators presume that the study may improve their understanding on calcium homeostasis and bone metabolism in general.

NCT ID: NCT02152228 Completed - Hypoparathyroidism Clinical Trials

A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism

Start date: July 2014
Phase: Phase 2
Study type: Interventional

This is an observational, international, open label, pilot study to evaluate the safety, tolerability and efficacy of an oral PTH (1-34) preparation produced by Entera Bio in adult hypoparathyroid volunteers.

NCT ID: NCT01922440 Active, not recruiting - Hypoparathyroidism Clinical Trials

A Registry for Participants With Chronic Hypoparathyroidism

PARADIGHM
Start date: July 30, 2013
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT01815021 Completed - Hypoparathyroidism Clinical Trials

A Study Comparing Amorphous Calcium Carbonate (ACC) Versus Crystalline Calcium CCS) in Hypoparathyroidism Patients

AMCS009
Start date: April 2013
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT01498341 Completed - Hypoparathyroidism Clinical Trials

Hypoparathyroidism in Denmark

HypoPT
Start date: August 2011
Phase: N/A
Study type: Observational

The purpose of this study is to identify the number of persons in Denmark with the diagnose hypoparathyroidism, autosomal dominant hypocalcaemia or pseudohypoparathyroidism. Also the investigators want to identify the causes and symptoms of these patients and their prognosis.

NCT ID: NCT01455181 Completed - Hypoparathyroidism Clinical Trials

A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary

REPEAT
Start date: August 19, 2011
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the effect of 6-months of treatment with NPSP558 in reducing requirements for supplemental oral calcium and active vitamin D, while maintaining stable total serum calcium levels in adult subjects with hypoparathyroidism.

NCT ID: NCT01297309 Completed - Hypoparathyroidism Clinical Trials

A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)

Start date: April 6, 2011
Phase: Phase 3
Study type: Interventional

This study is a long-term, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.

NCT ID: NCT01268098 Completed - Hypoparathyroidism Clinical Trials

Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)

Start date: February 9, 2011
Phase: Phase 3
Study type: Interventional

Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.

NCT ID: NCT01199614 Active, not recruiting - Hypoparathyroidism Clinical Trials

HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism

Start date: December 2009
Phase: Phase 3
Study type: Interventional

This is an open-label study of PTH(1-84) treatment that seeks: 1. To determine the actions of PTH(1-84) to provide long term control of serum calcium and urinary calcium excretion with use of standard amounts of calcium and vitamin D supplementation. 2. To determine the extent to which PTH(1-84) improves quality-of-life on long-term basis. 3. To establish the safety of PTH(1-84) when administered for up to 12 years. 4. To attempt to quantify improvements in the typical signs/symptoms of hypoparathyroidism post PTH administration. There will be one visit conducted every six months in the study offices of the principal investigator, Dr. John Bilezikian. In addition to these visits, there will be, for new patients who have not used PTH (1-84) before, a Screening Visit four weeks prior to the baseline visit for the purpose of performing screening labs as well as a Pre-Baseline Local Quest Lab performed to ensure stability prior to Baseline.