Treatment With Indapamide in Patients With Post-Surgical Hypoparathyroidism

NCT07034677 | Recruiting Phase 4 DMC

• 2 other identifiers: CTIS 2024-516000-41-012024-516000-41-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoparathyroidism Post-surgical

Keywords

hypoparathyroidism; indapamide; hypercalciuria

Outcome Measures

Primary Outcomes (1)

• Urinary calcium excretion

  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

  Day 15

Secondary Outcomes (3)

• Ionized calcium

  Day 15

• Sodium diet

  Day 15

• Safety (blood pressure)

  Day 15

Study Arms (2)

Indapamide

ACTIVE COMPARATOR

14 days with active drug Indapamide 1.5 mg/day

Drug: Indapamide 1.5 MG SR

Placebo

PLACEBO COMPARATOR

14 days with placebo

Drug: Placebo

Interventions

Indapamide 1.5 MG SR DRUG

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

Indapamide

Placebo DRUG

14 days treatment with placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lars Rejnmark: lead

Study Sites (1)

Department of Endocrinology and Internal Medicine

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Hypoparathyroidism; Hypercalciuria

Interventions

Indapamide

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Sarah Thornhøj, MD

CONTACT

+4540491821; sarthorn@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Ph.D., DMSc, prof

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: June 24, 2025
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: start data is time of publication and end 5 years after publication
• Access Criteria: By contacting the leading author of the publication in order to make a data sharing agreement, which should be signed. Proposal for agreement must contain planned analyses. Statistical analyses have to be approved by independent review before published. Data sharing agreement needs to be approved by the Technology Transfer Office (TTO), Aarhus University Hospital, Denmark

Locations

DK (1)