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Treatment With Indapamide in Patients With Post-Surgical Hypoparathyroidism

ConditionHypoparathyroidism Post-surgical
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorLars Rejnmark

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: IndapamideActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
Day 15

Secondary outcomes

1

Ionized calcium

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.

Time frame
Day 15
2

Sodium diet

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

Time frame
Day 15
3

Safety (blood pressure)

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

Time frame
Day 15

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lars Rejnmark

Lead sponsor

University of Aarhus

Sponsor institution

Source ClinicalTrials.gov
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