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Hypoparathyroidism clinical trials

View clinical trials related to Hypoparathyroidism.

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NCT ID: NCT06288490 Terminated - Hypoparathyroidism Clinical Trials

A Single Arm Study Comparing ACC Supplement to CCS in Management of Hypoparathyroidism

AMCS009
Start date: April 2013
Phase: N/A
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: NCT06222606 Recruiting - Thyroid Cancer Clinical Trials

Surgery for Thyroid Cancer With or Without Autofluorescence to Prevent Hypoparathyroidism

Start date: January 2024
Phase: N/A
Study type: Interventional

The study aims to test if use of autofluorescence imaging (AF) reduces the risk of developing hypoparathyroidism (hypoPT) following surgery for thyroid cancer, either total thyroidectomy (TT) or completion hemithyroidectomy (cHT).

NCT ID: NCT06020820 Completed - Clinical trials for Post-Thyroidectomy Hypoparathyroidism

Effectiveness Of Cervical Rehabilitation Program After Thyroidectomy

Start date: October 25, 2022
Phase: N/A
Study type: Interventional

The aim of this research is to determine the Effects of cervical rehabilitation program on neck pain, ROM and disability after thyroidectomy. Randomized controlled trials will be done at Pakistan ordinance factory (POF) Hospital. The sample size will be 52. The subjects were divided in two groups, with 26 subjects in Group A and 26 in Group B. Study duration was of 6 months. Sampling technique applied was Non probability Convenience Sampling technique. Both males and females of aged 30-50 years with thyroidectomy were included. Tools used in the study are Numeric Pain Rating Score (NPRS), goniometer and neck disability index (NDI).

NCT ID: NCT05965167 Active, not recruiting - Hypoparathyroidism Clinical Trials

Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo

Start date: May 11, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to characterize and compare the pharmacokinetics of hPTH(1 34) after treatment with a modified oral formulation (EBP11 and EBP22) versus two dose levels of Entera Bio's extensively studied oral EBP05 1.5 mg and 2.5 mg as well as the commercial Forteo 0.02 mg subcutaneous injection.

NCT ID: NCT05793853 Recruiting - Hypoparathyroidism Clinical Trials

Hypoparathyroidism Natural History

SHINE
Start date: August 25, 2022
Phase:
Study type: Observational

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. Funding Source- FDA OOPD

NCT ID: NCT05778071 Recruiting - Clinical trials for Endocrine System Diseases

Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism

CALYPSO
Start date: June 7, 2023
Phase: Phase 3
Study type: Interventional

This study is investigating the safety and efficacy of eneboparatide (AZP-3601) in patients with chronic hypoparathyroidism (cHP). During the first 24 weeks of the trial, participants will be randomized to receive eneboparatide or placebo. Study treatment is blinded: patients and doctors will not know which group each patient has been randomized to. All patients will start with a fixed dose of study treatment (eneboparatide or placebo), administered subcutaneously with a pre-filled pen. Study treatment will be individually titrated. After completion of the first 24 weeks, patients will be treated in the open label extension part of the study for 28 weeks. During this phase, all patients (including patients that were in the placebo group) will receive eneboparatide.

NCT ID: NCT05735015 Recruiting - Clinical trials for Post-Surgical Hypoparathyroidism

Study of the PTH-independent Effects of Encaleret on Mineral Homeostasis in Subjects With Postsurgical Hypoparathyroidism (PSH)

Start date: September 1, 2023
Phase: Phase 2
Study type: Interventional

Background: Parathyroid glands in the neck make a hormone that keeps blood calcium levels stable. Sometimes these glands are damaged or removed during neck surgery. This can lead to a condition called postsurgical hypoparathyroidism (PSH). People with PSH have low levels of calcium in their blood. Calcium and vitamin D pills can help them keep their blood calcium levels steady. But this can increase calcium in the urine and result in kidney problems. New treatments for PSH are needed. Objective: To test a drug (encaleret) in people with PSH. Eligibility: People aged 18 or older who have PSH. Design: Participants will be in the study for 6 months. They will have a screening visit and a treatment visit. Screening will take up to 2 days. Participants will have a physical exam. They will have blood and urine tests and tests of their heart function. They will have an ultrasound of their kidneys; they will lie on a table for 15 to 30 minutes while a wand is moved over their back. Treatment will require participants to stay in the clinic for 7 days and 6 nights. They will take the study drug (encaleret) by mouth twice a day for 5 days. They will have a small, flexible tube inserted into a vein; this will remain in place during the visit. Blood samples will be taken through the tube 4 to 9 times each day. Participants urine will be collected. Participants will have follow-up blood tests 1 week after leaving the clinic. They will have 3 follow-up phone calls.

NCT ID: NCT05684029 Recruiting - Thyroid Cancer Clinical Trials

Near-Infrared Autofluorescence With PTH Test Strip as an SOP of Parathyroid in Thyroid Surgery

PTFINDER
Start date: November 1, 2022
Phase:
Study type: Observational

This is a prospective study aiming to establish near-infrared autofluorescence technology and PTH test strip as a standardized process for finding and identifying parathyroid glands in thyroid surgery.

NCT ID: NCT05654701 Available - Hypoparathyroidism Clinical Trials

Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism

Start date: n/a
Phase:
Study type: Expanded Access

To provide palopegteriparatide (TransCon PTH), an investigational parathyroid hormone (PTH) replacement therapy in an expanded access setting for adult patients with hypoparathyroidism who have previously received PTH-treatment, who meet the eligibility criteria for this protocol as described below and have a clear unmet medical need that cannot be adequately treated by a commercial product or a clinical trial.

NCT ID: NCT05642741 Recruiting - Thyroidectomy Clinical Trials

Validation of a Hypoparathyroidism Self-questionnaire

SEV-HYPOPARA
Start date: May 2, 2023
Phase:
Study type: Observational

The aim of this study is to evaluate, for patients with post-thyroidectomy hypoparathyroidism (HoPT), the severity of their HoPT and to validate clinical scores from a self-administered questionnaire related to this disease (questionnaire which evaluates the severity of clinical symptoms related to HoPT and their impact on quality of life) in order to assess the severity of HoPT and to optimize support.