Ongoing Clinical Trials for Hypoparathyroidism
Currently, there are 6 clinical trials investigating new treatments and surgical techniques for hypoparathyroidism. These studies are taking place across multiple European countries and focus on hormone replacement therapies, medications to improve calcium management, and surgical methods to prevent the condition after thyroid surgery.
Clinical trial locations
- Belgium
- Denmark
- Study on Indapamide for Patients with Chronic Post-Surgical Hypoparathyroidism
- Study on the Effectiveness and Safety of Eneboparatide, Calcitriol, and Calcium Carbonate for Patients with Chronic Hypoparathyroidism
- Study on the Safety and Effectiveness of TransCon PTH for Adults with Hypoparathyroidism
- France
- Germany
- Hungary
- Italy
- Netherlands
- Norway
- Poland
- Portugal
- Spain
- Study on the Effectiveness and Safety of Eneboparatide in Patients with Chronic Hypoparathyroidism
- Study on the Effectiveness and Safety of Eneboparatide, Calcitriol, and Calcium Carbonate for Patients with Chronic Hypoparathyroidism
- Study on Using Indocyanine Green to Protect Parathyroid Glands During Thyroid Surgery for Patients with Hypothyroidism
Study on Indapamide for Patients with Chronic Post-Surgical Hypoparathyroidism
This trial, conducted in Denmark, investigates whether Indapamide, a medication typically used for other conditions, can help manage calcium levels in people who developed chronic post-surgical hypoparathyroidism. The condition occurs when parathyroid glands are damaged or removed during surgery, leading to difficulty maintaining proper calcium balance.
Main inclusion criteria: Participants must be 18 years or older and have been diagnosed with chronic post-surgical hypoparathyroidism for more than one year. They need to be taking at least 1 microgram of active vitamin D daily and have specific blood calcium levels (ionized plasma calcium between 1.15-1.25 mmol/L). Vitamin D levels must be at least 50 nmol/L, and magnesium levels must exceed 0.65 mmol/L. Participants must be able to read and understand Danish and provide informed consent.
Main exclusion criteria: The study excludes individuals who do not have chronic post-surgical hypoparathyroidism and those who cannot give proper consent.
Focus and goal: The trial examines how 14 days of daily Indapamide treatment affects the amount of calcium excreted in urine compared to placebo. It also monitors changes in blood calcium levels and the need for vitamin D and calcium supplements. Participants will follow a sodium-restricted diet during the placebo period to assess its impact on calcium management.
Investigational drug: Indapamide is a thiazide-like diuretic that works by inhibiting sodium reabsorption in the kidneys, which may help reduce calcium loss in urine. The study aims to determine if this medication can improve calcium management in people with post-surgical hypoparathyroidism.
Study of Indocyanine Green Angiography to Prevent Hypoparathyroidism in Patients Undergoing Total Thyroid Removal
This French study tests whether using a special imaging dye called indocyanine green during thyroid surgery can help surgeons better identify and protect the parathyroid glands, potentially preventing hypoparathyroidism after surgery.
Main inclusion criteria: Participants must be adults aged 18 or older who need complete thyroid removal surgery. They must be covered by health insurance, able to understand and agree to study procedures, and willing to sign informed consent. Both men and women can participate.
Main exclusion criteria: People under 18 or over 65 years old cannot participate. Those with previous thyroid surgery, known low calcium levels before surgery, allergies to indocyanine green, pregnancy or breastfeeding, kidney disease, medications affecting calcium levels, parathyroid disorders, serious heart, liver or blood disorders, or mental conditions affecting study compliance are excluded.
Focus and goal: The trial compares outcomes between patients who receive indocyanine green imaging during surgery and those who undergo standard surgery. The dye helps surgeons visualize blood flow to the parathyroid glands under special infrared light, making it easier to preserve these important structures. Calcium levels are monitored for up to 6 months after surgery.
Investigational drug: Indocyanine green is administered as an injection at up to 0.5 milligrams per kilogram of body weight. The dye binds to blood proteins and fluoresces under near-infrared light, allowing surgeons to see the parathyroid glands and their blood supply more clearly during the procedure.
Study on the Effectiveness and Safety of Eneboparatide in Patients with Chronic Hypoparathyroidism
This Spanish trial evaluates eneboparatide, a new medication that mimics the action of parathyroid hormone, for managing chronic hypoparathyroidism. The study aims to determine if this treatment can help patients reduce their dependence on vitamin D and calcium supplements.
Main inclusion criteria: Participants must be between 18 and 80 years old with documented chronic hypoparathyroidism for at least 12 months. They need low parathyroid hormone levels and specific calcium levels in blood tests. Participants must require at least 0.5 micrograms of calcitriol or 1 microgram of alphacalcidol daily, plus at least 1000 mg of additional oral calcium daily. They must successfully complete an optimization period with stable calcium levels and have normal kidney function with an estimated glomerular filtration rate of at least 30 mL/minute/1.73 m². Participants must be able to self-administer daily injections or have someone assist them.
Main exclusion criteria: People with other serious medical conditions, those currently in another clinical trial, recent or planned surgery, pregnancy or breastfeeding, drug or alcohol abuse, allergies to the study medication, inability to follow study procedures, unstable mental health conditions, cancer diagnosis in the past five years, or severe kidney or liver disease are excluded.
Focus and goal: Over 24 weeks, the study compares eneboparatide with placebo to assess whether the medication can help patients maintain normal calcium levels while reducing their need for active vitamin D and oral calcium supplements. The trial also evaluates changes in symptoms and physical functioning.
Investigational drug: Eneboparatide is a parathyroid hormone receptor agonist administered daily through subcutaneous injection using a pre-filled pen. It works by stimulating the same receptors as natural parathyroid hormone, helping to regulate calcium levels in the body.
Study on Using Indocyanine Green to Protect Parathyroid Glands During Thyroid Surgery for Patients with Hypothyroidism
This Spanish study examines whether indocyanine green dye can help surgeons better identify and preserve parathyroid glands during thyroid removal surgery, potentially reducing the risk of developing hypoparathyroidism afterward.
Main inclusion criteria: Participants must be 18 years or older and require total thyroidectomy with or without central cervical lymph node removal due to thyroid disease. They must be able to understand the study and sign informed consent. Both men and women can participate.
Main exclusion criteria: Patients with hypothyroidism cannot participate in this particular trial.
Focus and goal: The study uses indocyanine green during surgery to visualize blood flow patterns around the parathyroid glands. Surgeons compare outcomes with and without using the dye. Blood tests measure parathyroid hormone and calcium levels before surgery, within 24 hours after, and at 1, 3, 6, and 12 months follow-up. The primary aim is to determine if the imaging technique helps prevent permanent hypoparathyroidism.
Investigational drug: Indocyanine green is administered intravenously during surgery. The dye binds to plasma proteins and can be visualized using near-infrared fluorescence imaging, making it easier for surgeons to see the blood vessels supplying the parathyroid glands and avoid damaging them during thyroid removal.
Study on the Effectiveness and Safety of Eneboparatide, Calcitriol, and Calcium Carbonate for Patients with Chronic Hypoparathyroidism
This large international trial spans 10 European countries and investigates eneboparatide as a treatment for chronic hypoparathyroidism. The study examines whether this hormone replacement therapy can help patients maintain normal calcium levels while reducing their need for conventional supplements.
Main inclusion criteria: Participants must be between 18 and 80 years old with chronic hypoparathyroidism documented for at least 12 months in medical records. They need low parathyroid hormone levels and specific serum calcium levels. Daily treatment requirements include at least 0.5 micrograms of calcitriol or 1 microgram of alphacalcidol, plus at least 1000 mg of extra oral calcium beyond dietary intake. Participants must successfully complete an optimization period achieving specific calcium levels in two tests at least one week apart. Normal serum magnesium levels are required, with vitamin D levels between 30 and 70 ng/mL. Kidney function must show an estimated glomerular filtration rate of at least 30 mL/minute/1.73 m². Participants must be able to perform daily self-injections in the abdomen or have someone assist them using a pre-filled pen.
Main exclusion criteria: People with conditions other than hypoparathyroidism, unwillingness to stop interfering medications, certain medical history conditions, pregnancy or breastfeeding, and inability to comply with study procedures are excluded.
Focus and goal: The 24-week treatment period compares eneboparatide with placebo to evaluate effectiveness in reducing the need for active vitamin D and oral calcium supplements while maintaining normal serum calcium levels. The study assesses changes in symptoms and physical functioning throughout the treatment period.
Investigational drug: Eneboparatide is administered as a daily subcutaneous injection using a pre-filled pen. As a parathyroid hormone receptor agonist, it mimics the action of natural parathyroid hormone to help regulate calcium levels in the body. The trial includes accompanying medications such as calcitriol and calcium carbonate for calcium management.
Study on the Safety and Effectiveness of TransCon PTH for Adults with Hypoparathyroidism
This trial, conducted in Italy, Germany, Norway, and Denmark, studies TransCon PTH, a medication designed to provide sustained release of parathyroid hormone. The study evaluates whether this treatment can help adults with hypoparathyroidism maintain normal calcium levels.
Main inclusion criteria: Participants must be 18 years or older and able to give themselves daily injections under the skin using a pre-filled pen, or have someone assist them. They need chronic hypoparathyroidism present for at least 26 weeks, which can be due to surgery, autoimmune issues, genetic reasons, or unknown causes. A stable dose of active vitamin D and calcium supplements is required for at least 12 weeks before starting. Participants must adjust their supplements to reach target levels of vitamin D, magnesium, and calcium before enrollment. Body Mass Index must be between 17 and 40 kg/m². Those 25 years or younger need an x-ray showing bone growth is complete. Kidney function must show an estimated glomerular filtration rate greater than 30 mL/min/1.73m². Thyroid-stimulating hormone levels must be within normal limits, and any thyroid hormone replacement therapy must be stable for at least 12 weeks.
Main exclusion criteria: Only adults 18 years or older with confirmed hypoparathyroidism can participate. Vulnerable populations who cannot give consent or are in dependent relationships are excluded.
Focus and goal: The study begins with a randomized phase where participants receive either TransCon PTH or placebo, followed by an open-label extension where all participants receive the active treatment. The primary focus is monitoring changes in blood and urine calcium levels over four weeks, along with assessing the need for additional vitamin D and calcium supplements. The trial aims to determine if TransCon PTH can maintain normal calcium levels without requiring additional supplements.
Investigational drug: TransCon PTH contains palopegteriparatide and is administered as a daily subcutaneous injection using a pre-filled pen. The medication provides sustained release of parathyroid hormone, helping to regulate calcium and phosphate balance in the body as a hormone replacement therapy.
Summary
The six ongoing clinical trials for hypoparathyroidism represent diverse approaches to managing this condition. Three trials focus on hormone replacement therapies, with eneboparatide being tested in two separate studies and TransCon PTH in another. These medications aim to replace the missing parathyroid hormone and help patients reduce their dependence on conventional calcium and vitamin D supplements.
Two trials investigate the use of indocyanine green dye during thyroid surgery to help surgeons better identify and preserve parathyroid glands, potentially preventing hypoparathyroidism from developing after surgery. One trial in Denmark explores whether Indapamide, a medication typically used for other purposes, might help manage calcium levels in people who already have the condition following surgery.
The largest trial, testing eneboparatide combined with calcitriol and calcium carbonate, spans 10 European countries including the Netherlands, Denmark, Belgium, Italy, Spain, Germany, France, Hungary, Poland, and Portugal. This widespread geographic distribution suggests strong interest in developing new treatment options for this rare condition. Denmark appears particularly active in hypoparathyroidism research, hosting three different trials.
Together, these studies address both prevention of hypoparathyroidism through improved surgical techniques and better management of chronic cases through new medications. The variety of approaches reflects the ongoing need for improved treatments that can help patients maintain normal calcium levels with fewer side effects and better quality of life.
