Treatment With Indapamide in Patients With Post-Surgical Hypoparathyroidism

NCT ID: NCT07034677

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Hypoparathyroidism Post-surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Indapamide

14 days with active drug Indapamide 1.5 mg/day

Group Type ACTIVE_COMPARATOR

Indapamide 1.5 MG SR

Intervention Type DRUG

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

Placebo

14 days with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

14 days treatment with placebo

Interventions

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Indapamide 1.5 MG SR

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

Intervention Type DRUG

Placebo

14 days treatment with placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lars Rejnmark

OTHER

Sponsor Role lead

Responsible Party

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Lars Rejnmark

MD, Ph.D., DMSc, prof

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Endocrinology and Internal Medicine

Aarhus, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Sarah Thornhøj, MD

Role: CONTACT

+4540491821

Facility Contacts

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Role: primary

Other Identifiers

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2024-516000-41-01

Identifier Type: CTIS

Identifier Source: secondary_id

CTIS 2024-516000-41-01

Identifier Type: -

Identifier Source: org_study_id

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