Hypoparathyroidism Post-surgical
Conditions
Keywords
hypoparathyroidism, indapamide, hypercalciuria
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.
Interventions
14 days treatment with indapamide 1.5 mg/day compared to placebo
DRUGPlacebo
14 days treatment with placebo
Sponsors
Lars Rejnmark
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary calcium excretion | Day 15 | 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
| Measure | Time frame | Description |
|---|---|---|
| Ionized calcium | Day 15 | 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 | Day 15 | 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) | Day 15 | To assess the safety (blood pressure) of daily treatment with Indapamide for 14 days compared to placebo |
Countries
Denmark
Contacts
Primary ContactSarah Thornhøj, MD
Outcome results
None listed