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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516000-41-01 | EU Trial (CTIS) Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indapamide | Active Comparator | 14 days with active drug Indapamide 1.5 mg/day |
|
| Placebo | Placebo Comparator | 14 days with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indapamide 1.5 MG SR | Drug | 14 days treatment with indapamide 1.5 mg/day compared to placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 15 |
| Sodium diet |
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Inclusion Criteria:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Thornhøj, MD | Contact | +4540491821 | sarthorn@rm.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology and Internal Medicine | Recruiting | Aarhus | 8200 | Denmark |
Only IPD used in the results publication
start data is time of publication and end 5 years after publication
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
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| ID | Term |
|---|---|
| D007011 | Hypoparathyroidism |
| D053565 | Hypercalciuria |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D007190 | Indapamide |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Placebo |
| Drug |
14 days treatment with placebo |
|
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
| Day 15 |
| Safety (blood pressure) | To assess the safety (blood pressure) of daily treatment with Indapamide for 14 days compared to placebo | Day 15 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Sulfur Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |