Treatment With Indapamide in Patients With Post-Surgical Hypoparathyroidism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indapamide 1.5 MG SR, Placebo.
- Who it may be relevant to
- Registry conditions: Hypoparathyroidism Post-surgical. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Indapamide 1.5 MG SR
14 days treatment with indapamide 1.5 mg/day compared to placebo - Drug Placebo
14 days treatment with placebo
Primary outcome measures
- Urinary calcium excretion [Time frame: Day 15]
Secondary outcome measures (3)
- Ionized calcium [Time frame: Day 15]
- Sodium diet [Time frame: Day 15]
- Safety (blood pressure) [Time frame: Day 15]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- Department of Endocrinology and Internal Medicine — Aarhus
Identifiers
NCT: NCT07034677 · CTIS 2024-516000-41-01 · 2024-516000-41-01