Actively Recruiting
Treatment With Indapamide in Patients With Post-Surgical Hypoparathyroidism
Led by Lars Rejnmark · Updated on 2025-08-11
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the effects of daily treatment with Indapamide on urinary calcium levels in patients who have post-surgical hypoparathyroidism. The trial focuses on patients diagnosed with this condition more than a year ago and evaluates how Indapamide influences calcium excretion compared to a placebo. The study is a randomized, triple-blind Phase 4 trial designed to provide insights into managing calcium levels in this specific patient group. Participants will receive either Indapamide 1.5 mg daily or a placebo for 14 days. The trial includes two study arms: one with the active drug Indapamide and the other with placebo treatment, each lasting for 14 days. The treatments are taken daily, and participants are monitored closely throughout the treatment period to assess the drug's effect on calcium excretion. During the study, participants will undergo weekly blood sampling and collect 24-hour urine samples every two weeks to monitor calcium and other relevant blood levels. Researchers will measure urinary calcium excretion on day 15 as the primary outcome, along with ionized calcium levels, sodium diet, and blood pressure safety assessments. The study runs from August 2025 to December 2025, with careful safety monitoring and follow-up throughout the trial period.
CONDITIONS
Brief Title
Treatment With Indapamide in Patients With Post-Surgical Hypoparathyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic post surgical hypoparathyroidism diagnosed more than 1 year ago
- Age 18 years or older
- Require treatment with active vitamin D at least 1 microgram per day
- Ionized plasma calcium between 1.15 and 1.25 mmol/L
- 25(OH)D vitamin level at least 50 nmol/L
- Plasma magnesium above 0.65 mmol/L
- Able to read and understand Danish
- Willing and able to sign the informed consent form
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73 m2
- Active cancer or cancer treatment within 1 year, except thyroid and basal cell skin cancer
- Pregnancy, plans to become pregnant, or breastfeeding within the past year
- Abnormal arterial pressure at screening including symptomatic hypotension or systolic blood pressure below 100 mmHg
- Plasma potassium below 3.5 mmol/L
- Diseases affecting calcium metabolism such as recent prolonged immobility, untreated diabetes (HbA1c over 53 mmol/mol), severe liver disease or hepatic encephalopathy, untreated thyroid disease
- Current diseases affecting gastrointestinal absorption
- Use of lithium or diuretics within 4 weeks before treatment start
- Known allergy or sensitivity to Indapamide, its excipients, or sulfonamides
- Known galactosemia, lactase deficiency, or glucose-galactose malabsorption
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive daily treatment with either Indapamide 1.5 mg or placebo for 14 days to study the effect on urinary calcium excretion.
Weekly blood sampling and 24-hour urine collection every second week
Trial Site Locations
Total: 1 location
1
Department of Endocrinology and Internal Medicine
Aarhus, Denmark, 8200
Actively Recruiting
Research Team
S
Sarah Thornhøj, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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