HyperparathyroidismNCT02591160
Optimal HCTZ Cessation for Diagnosis of Hyperparathyroidism
A study testing HCTZ cessation in people with Hyperparathyroidism, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Primary hyperparathyroidism (PHPT) is the most common cause of hypercalcemia in the ambulatory setting. PHPT may be cured with surgery and indications for intervention have been defined and include urinary calcium/creatinine clearance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperparathyroidism
- What is being tested?
- HCTZ cessation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 13 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Elevated calcium on at least two separate draws with coexistent elevated parathyroid hormone (PTH) on at least one occasion.
- Taking Hydrochlorothiazide for hypertension
- Following a "wash period", patients must have a normal range 25-hydroxy Vitamin D level, thyroid stimulation hormone (TSH) and serum magnesium levels.
- Controlled blood pressure
- Willingness to comply with serial sampling
- English as the primary language
- Adults 18 years and older
Who cannot join
- Unable to cease Hydrochlorothiazide for any reason
- Congestive heart failure
- Renal insufficiency (GFR <60)
- Cardiovascular event in the last 3 months - include myocardial infarction, new onset atrial fibrillation, and new onset bundle branch block
- Take lithium or other diuretic medication in last 3 months
- Positive family history of familial hypocalciuric hypercalcemia (FHH)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Hydrochlorothiazide Cessation in Diagnosis of Hyperparathyroidism
Primary hyperparathyroidism (PHPT) is the most common cause of hypercalcemia in the ambulatory setting. PHPT may be cured with surgery and indications for intervention have been defined and include urinary calcium/creatinine clearance. Hydrochlorothiazide (HCTZ), the most commonly prescribed medication for hypertension, reduces urinary calcium excretion and confounds urinary testing. As a result, it is universally recommended that thiazide diuretics be stopped in advance of urinary testing. To date, no studies are available to provide evidence-based guidance as to how long HCTZ must be held for urinary calcium excretion to return to steady state in PHPT. The objective of this study is to serially calculate urinary calcium/creatinine clearance ration in patients with suspected PHPT while holding HCTZ to determine the minimum duration of medication cessation necessary for urinary calcium clearance to reach steady state.
Read the detailed description
In this study, adult patients will submit serum and 24 hour urine samples prior to HCTZ cessation and at the following intervals after cessation: 4-6 days, 14-16 days, 28-30 days, adn 90-92 days. To minimize confounding variable, patients will take supplemental Vitamin D and Calcium, monitor their daily calcium intake, and monitor blood pressure weekly. Alternative, non-diuretic, antihypertensive medication(s) may be prescribed at the discretion of the enrolling provider.
- Conditions
- Hyperparathyroidism
- Being tested
- HCTZ cessation
- Medical subject headings
- Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCTZ cessationProcedure or surgery
Patients will stop taking their HCTZ for 3 months
| Study group | Role | What they receive |
|---|---|---|
| HCTZ cessation | Other | Patients will stop taking HCTZ for 3 months while submitting serial blood and 24 hour urine samples Receives: Procedure: HCTZ cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days for Calcium/Creatinine Clearance to normalize after stopping HCTZ
Determination of the HCTZ cessation window
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startMay 2015
- Primary completion13 Sep 2017
- Study completion13 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert P. Zitsch III, University of Missouri-Columbia
- Investigators
- Robert P Zitsch, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591160
- Sponsor's protocol ID
- 1213821
- Status last verified
- Jan 2018
- First submitted
- 27 Oct 2015
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Hydrochlorothiazide Cessation in Diagnosis of Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT02591160
- Acronym / sponsor ID
- 1213821
- Conditions
- Hyperparathyroidism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- 13 Sep 2017 (actual)
- Study completion
- 13 Sep 2017 (actual)
- First posted
- 29 Oct 2015 (estimated)
- 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.
Primary hyperparathyroidism (PHPT) is the most common cause of hypercalcemia in the ambulatory setting. PHPT may be cured with surgery and indications for intervention have been defined and include urinary calcium/creatinine clearance. Hydrochlorothiazide (HCTZ), the most commonly prescribed medication for hypertension, reduces urinary calcium excretion and confounds urinary testing. As a result, it is universally recommended that thiazide diuretics be stopped in advance of urinary testing. To date, no studies are available to provide evidence-based guidance as to how long HCTZ must be held for urinary calcium excretion to return to steady state in PHPT. The objective of this study is to serially calculate urinary calcium/creatinine clearance ration in patients with suspected PHPT while holding HCTZ to determine the minimum duration of medication cessation necessary for urinary calcium clearance to reach steady state.
Detailed description
In this study, adult patients will submit serum and 24 hour urine samples prior to HCTZ cessation and at the following intervals after cessation: 4-6 days, 14-16 days, 28-30 days, adn 90-92 days. To minimize confounding variable, patients will take supplemental Vitamin D and Calcium, monitor their daily calcium intake, and monitor blood pressure weekly. Alternative, non-diuretic, antihypertensive medication(s) may be prescribed at the discretion of the enrolling provider.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCTZ cessation | Other | Procedure: HCTZ cessationPatients will stop taking HCTZ for 3 months while submitting serial blood and 24 hour urine samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Elevated calcium on at least two separate draws with coexistent elevated parathyroid hormone (PTH) on at least one occasion.
- Taking Hydrochlorothiazide for hypertension
- Following a "wash period", patients must have a normal range 25-hydroxy Vitamin D level, thyroid stimulation hormone (TSH) and serum magnesium levels.
- Controlled blood pressure
- Willingness to comply with serial sampling
Key exclusion criteria (6 listed)
- Unable to cease Hydrochlorothiazide for any reason
- Congestive heart failure
- Renal insufficiency (GFR <60)
- Cardiovascular event in the last 3 months - include myocardial infarction, new onset atrial fibrillation, and new onset bundle branch block
- Take lithium or other diuretic medication in last 3 months
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 |
|---|---|---|
| HCTZ cessationPatients will stop taking their HCTZ for 3 months | Procedure or surgery | HCTZ cessation |
Primary outcome
Number of days for Calcium/Creatinine Clearance to normalize after stopping HCTZ
Time frame: 2-3 years
Determination of the HCTZ cessation window
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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. This study is not recruiting at the moment.
Robert P Zitsch, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCTZ cessation in people with Hyperparathyroidism, run by University of Missouri-Columbia at 1 site in United States.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 8 Jan 2018. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days for Calcium/Creatinine Clearance to normalize after stopping HCTZ (time frame: 2-3 years). 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 8 Jan 2018.