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NCT Number: NCT07034677

Treatment With Indapamide in Patients With Post-Surgical Hypoparathyroidism

The aim of this study is to investigate the effect of daily treatment with Indapamide for 14 days on urinary calcium excretion in patients with post surgical hypoparathyroidisme.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Endocrinology and Internal Medicine

Aarhus, 8200, Denmark

Location status: Recruiting

Location contact

About this study

The aim of this study is to investigate the effect of daily treatment with Indapamide for 14 days on urinary calcium excretion in patients with post surgical hypoparathyroidisme.

Patients will do weekly blood sampling and 24 hour urine collection every second week.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m3
  • 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
  • Known allergy or sensitivity to Indapamide, its excipients or sulfonamides
  • Known galactosemia, lactase deficiency, or glucose-galactose malabsorption

Treatment and study plan

Indapamide 1.5 MG SR

Drug

14 days treatment with indapamide 1.5 mg/day compared to placebo

Placebo

Drug

14 days treatment with placebo

Primary outcomes

  1. Urinary calcium excretion

    Time frame: Day 15

    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

Secondary outcomes

  1. Ionized calcium

    Time frame: Day 15

    To assess if treatment with Indapamide can affect the level of ionized calcium in the blood during treatment with Indapamide and hereby reduce the need for supplementation with oral calcium and active vitamin D.

  2. Sodium diet

    Time frame: Day 15

    assess the efficacy of a low sodium diet in the placebo period on plasma ionized calcium and on the 24-hour urinary calcium excretion in patients with hypoparathyroidism

  3. Safety (blood pressure)

    Time frame: Day 15

    To assess the safety (blood pressure) of daily treatment with Indapamide for 14 days compared to placebo

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Thornhøj, MD

CONTACT

[email protected]

+4540491821

Sponsors and collaborators

Lead sponsor

Lars Rejnmark

Other

Registry information

Acronym: HYPOCARE treat

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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