Treatment With Indapamide in Patients With Post-Surgical Hypoparathyroidism

Phase 4

Recruiting

• Conditions: Hypoparathyroidism Post-surgical
• Interventions: Drug: Indapamide 1.5 MG SR; Drug: Placebo

• Registration Number: NCT07034677
• Lead Sponsor: Lars Rejnmark

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-15
• Study First Submitted QC: 2025-06-15
• Last Update Submitted: 2025-06-15
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Chronic post surgical hypoparathyroidism diagnosed > 1 year ago
2. Age ≥ 18 years
3. Require treatment with active vitamin D ≥ 1 µg/day
4. Ionized plasma calcium between 1.15-1.25 mmol/L
5. 25(OH)D vitamin ≥ 50 nmol/L
6. Plasma magnesium > 0.65 mmol/L
7. Able to read and understand Danish
8. Willing and able to sign the informed consent form

Exclusion Criteria

1. Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m3

2. Active cancer or former (except thyroid and basal cell skin) cancer treatment < 1 year ago

3. Pregnancy, pregnancy plans, or breastfeeding < 1 year ago

4. Abnormal arterial pressure at time of screening defined as symptomatic hypotension or systolic blood pressure < 100 mmHg

5. Plasma potassium < 3.5 mmol/L

6. Any current disease that might affect the calcium metabolism such as but not limited to:

   1. Recent prolonged immobility
   2. Untreated diabetes (HbA1c > 53 mmol/mol)
   3. Severe liver disease or hepatic encephalopathy
   4. Untreated thyroid disease

7. Current disease that might affect gastrointestinal absorption

8. Use of medications such as lithium or diuretics within 4 weeks prior to start of treatment

9. Known allergy or sensitivity to Indapamide, its excipients or sulfonamides

10. Known galactosemia, lactase deficiency, or glucose-galactose malabsorption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Indapamide	Indapamide 1.5 MG SR	14 days with active drug Indapamide 1.5 mg/day
Placebo	Placebo	14 days with placebo

Primary Outcome Measures

Name	Time	Method
Urinary calcium excretion	After 14 days of treatment	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 Outcome Measures

Name	Time	Method
Ionized calcium	14 days of treatment	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.
Sodium diet	14 days of treatment	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
Safety (blood pressure and AE)	14 days of treatment	To assess the safety (blood pressure and number of adverse events) of daily treatment with Indapamide for 14 days compared to placebo

Trial Locations

Locations (1)

Department of Endocrinology and Internal Medicine; 🇩🇰 Aarhus, Denmark