Authorised Therapeutic use (Phase IV) Hypoparathyroidism

HYPOCARE TREAT

EU CTIS ID: 2024-516000-41-01

What this study is testing

To investigate the effect of daily treatment with Indapamide for 14 days compared to placebo on urinary calcium excretion in patients with chronic post-surgical hypoparathyroidism

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Chronic post surgical hypoparathyroidism diagnosed > 1 year ago
  • Age ≥ 18 years
  • Require treatment with active vitamin D ≥ 1 µg/day
  • Ionized plasma calcium between 1.15-1.25 mmol/L
  • 25(OH)D vitamin ≥ 50 nmol/L
  • Plasma magnesium > 0.65 mmol/L

You likely can't join if

  • Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m3
  • Known allergy or sensitivity to Indapamide, its excipients or sulfonamides
  • Known galactosemia, lactase deficiency, or glucose-galactose malabsorption
  • Active cancer or former (except thyroid and basal cell skin) cancer treatment < 1 year ago
  • Pregnancy, pregnancy plans, or breastfeeding < 1 year ago
  • Abnormal arterial pressure at time of screening defined as symptomatic hypotension or systolic blood pressure < 100 mmHg
See the full eligibility criteria
Who can join
  • Chronic post surgical hypoparathyroidism diagnosed > 1 year ago
  • Age ≥ 18 years
  • Require treatment with active vitamin D ≥ 1 µg/day
  • Ionized plasma calcium between 1.15-1.25 mmol/L
  • 25(OH)D vitamin ≥ 50 nmol/L
  • Plasma magnesium > 0.65 mmol/L
  • Able to read and understand Danish
  • Willing and able to sign the informed consent form
What rules you out
  • Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m3
  • Known allergy or sensitivity to Indapamide, its excipients or sulfonamides
  • Known galactosemia, lactase deficiency, or glucose-galactose malabsorption
  • Active cancer or former (except thyroid and basal cell skin) cancer treatment < 1 year ago
  • Pregnancy, pregnancy plans, or breastfeeding < 1 year ago
  • Abnormal arterial pressure at time of screening defined as symptomatic hypotension or systolic blood pressure < 100 mmHg
  • Plasma potassium < 3.5 mmol/L
  • Any current disease that might affect the calcium metabolism such as but not limited to: Recent prolonged immobility, untreated diabetes (HbA1c > 53 mmol/mol), severe liver disease or hepatic encephalopathy, untreated thyroid disease
  • Current disease that might affect gastrointestinal absorption
  • Use of medications such as lithium or diuretics within 4 weeks prior to start of treatment

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.