Hypoparathyroidism Post-surgicalPhase 4HYPOCARE treatNCT07034677
Treatment With Indapamide in Patients With Post-Surgical Hypoparathyroidism
A Phase 4 study testing Indapamide 1.5 MG SR in people with Hypoparathyroidism Post-surgical, run by Lars Rejnmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism Post-surgical
- What is being tested?
- Indapamide 1.5 MG SR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2025to Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Endocrinology and Internal Medicine
Aarhus, 8200
20257127, sarthorn@rm.dk
About this study
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.
Read the 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.
- Conditions
- Hypoparathyroidism Post-surgical
- Being tested
- Indapamide 1.5 MG SR, Placebo
- Keywords
- hypoparathyroidism, indapamide, hypercalciuria
- Medical subject headings
- Hypoparathyroidism, Hypercalciuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indapamide 1.5 MG SRDrug
14 days treatment with indapamide 1.5 mg/day compared to placebo
PlaceboDrug
14 days treatment with placebo
| Study group | Role | What they receive |
|---|---|---|
| Indapamide | Active comparator | 14 days with active drug Indapamide 1.5 mg/day Receives: Drug: Indapamide 1.5 MG SR |
| Placebo | Placebo comparator | 14 days with placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 15
Secondary outcomes (3)
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.
Measured: Day 15
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
Measured: Day 15
Safety (blood pressure)
To assess the safety (blood pressure) of daily treatment with Indapamide for 14 days compared to placebo
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoparathyroidism Post-surgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lars Rejnmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Rejnmark, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034677
- Sponsor's protocol ID
- CTIS 2024-516000-41-01
- Other IDs
- 2024-516000-41-01
- Acronym
- HYPOCARE treat
- Status last verified
- Aug 2025
- First submitted
- 15 Jun 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Indapamide in Patients With Post-Surgical Hypoparathyroidism
- ClinicalTrials.gov ID
- NCT07034677
- Acronym / sponsor ID
- HYPOCARE treat / CTIS 2024-516000-41-01
- Conditions
- Hypoparathyroidism Post-surgical
- Keywords
- hypoparathyroidism, indapamide, hypercalciuria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Lars RejnmarkUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indapamide | Active comparator | Drug: Indapamide 1.5 MG SR14 days with active drug Indapamide 1.5 mg/day |
| Placebo | Placebo comparator | Drug: Placebo14 days with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indapamide 1.5 MG SR14 days treatment with indapamide 1.5 mg/day compared to placebo | Drug | Indapamide |
| Placebo14 days treatment with placebo | Drug | Placebo |
Primary outcome
Urinary calcium excretion
Time frame: 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
3 secondary outcomes
Ionized calcium
Time frame: Day 15
Sodium diet
Time frame: Day 15
Safety (blood pressure)
Time frame: Day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indapamide 1.5 MG SR in people with Hypoparathyroidism Post-surgical, run by Lars Rejnmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Thornhøj, MD (+4540491821, sarthorn@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary calcium excretion (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.