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Hypoparathyroidism clinical trials

View clinical trials related to Hypoparathyroidism.

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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: NCT00824226 Completed - Hypoparathyroidism Clinical Trials

Magnesium Treatment in Hypoparathyroidism

Start date: January 2009
Phase: N/A
Study type: Interventional

Study hypothesis: supplementary magnesium may influence the blood calcium level in treated hypoparathyroid patients. Patients will be treated with supplementary magnesium (350 mg/day) for 3 weeks. Calcium and other relevant blood parameters will be measured before the treatment, at the end of treatment and 2 weeks after stopping treatment.

NCT ID: NCT00793689 Completed - Hypoparathyroidism Clinical Trials

Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test After Total Thyroidectomy

Start date: March 2008
Phase: N/A
Study type: Observational

In the study will be included patients that have undergone total thyroidectomy and do not display obvious clinical or laboratory hypoparathyroidism. On the third postoperative day and before the patient's exit from the hospital, the patient will undergo an intravenous infusion test with 35ml/m2 dilution of 8.4%(w/v) sodium bicarbonate in two minutes. Three months after the operation, if the study conditions are still met, the patient will undergo an additional parathyroid hormone (PTH) measurement and sodium bicarbonate infusion test and the parathyroid function will be evaluated again.

NCT ID: NCT00743782 Completed - Hypoparathyroidism Clinical Trials

Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism

Start date: August 22, 2008
Phase: Early Phase 1
Study type: Interventional

This study will evaluate the safety, biological activity, and pharmacokinetics of PTH delivered by subcutaneous injection compared with an infusion pump. We anticipate pump delivery of PTH will be more physiologic because it mimics normal parathyroid gland secretion of PTH. We expect that pump delivery will simultaneously normalize blood and urine calcium, phosphorus and magnesium levels with minimal or no fluctuations throughout the day. Pump therapy will require lower PTH doses and should normalize markers of bone turnover. We expect the improved metabolic control during pump therapy will be especially evident in patients with more severe forms of hypoparathyrodism where there is an unmet need for improved therapy.

NCT ID: NCT00732615 Completed - Hypoparathyroidism Clinical Trials

Use of NPSP558 in the Treatment of Hypoparathyroidism

REPLACE
Start date: December 18, 2008
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT00730210 Completed - Hypoparathyroidism Clinical Trials

Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of Life

HypoPTH
Start date: June 2008
Phase: Phase 2
Study type: Interventional

The aim of the study is to assess whether PTH (1-84) therapy posses advantages compared to conventional treatment in patients with hypoparathyroidism on muscle function, quality of life, calcium homeostasis, bone metabolism, and body composition.